Women & Health
ISSN: 0363-0242 (Print) 1541-0331 (Online) Journal homepage: http://www.tandfonline.com/loi/wwah20
Effects of Active/Passive Interventions on Pain, Anxiety and Quality of Life in Women with Fibromyalgia: Randomized Controlled Pilot Trial Gamze EKİCİ PT, PhD, Edibe Unal PT, PhD, Turkan Akbayrak PT, PhD, Naciye Vardar-Yagli PT, PhD, Yavuz Yakut PT, PhD & Erdem Karabulut PhD To cite this article: Gamze EKİCİ PT, PhD, Edibe Unal PT, PhD, Turkan Akbayrak PT, PhD, Naciye Vardar-Yagli PT, PhD, Yavuz Yakut PT, PhD & Erdem Karabulut PhD (2016): Effects of Active/Passive Interventions on Pain, Anxiety and Quality of Life in Women with Fibromyalgia: Randomized Controlled Pilot Trial, Women & Health, DOI: 10.1080/03630242.2016.1153017 To link to this article: http://dx.doi.org/10.1080/03630242.2016.1153017
Accepted author version posted online: 16 Feb 2016.
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Date: 18 February 2016, At: 15:49
Effects of active/passive ınterventions on pain, anxiety and quality of life in women with fibromyalgia: Randomized controlled pilot trial
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Gamze Ekici, PT, PhD
Edibe Unal, PT, PhD, Turkan Akbayrak, PT, PhD, Naciye Vardar-Yagli, PT, PhD, and Yavuz Yakut, PT, PhD
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Department of Physiotherapy and Rehabilitation, Faculty of Health Science, Hacettepe University, Ankara, Turkey
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Erdem Karabulut, PhD
Department of Biostatistics, Faculty of Medicine, Hacettepe University, Ankara, Turkey Abstract
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This study was compared the effects of Pilates exercises and connective tissue massage (CTM) on pain intensity, pain-pressure threshold and tolerance, anxiety, progress, and health-related
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quality of life in females with fibromyalgia. It was a pilot, assessor masked, randomized controlled trial conducted between January and August 2013. Twenty-one women with
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fibromyalgia were randomly assigned to the pilates exercise program (six of whom did not complete the program), and 22 were randomly assigned to CTM (one of whom did not complete this program). Each group received the assigned intervention three times per week during a four-
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Faculty of Health Science, Hacettepe University, Ankara, Turkey
week period. Visual analogue scale, algometry, state-trait anxiety inventory, fibromyalgia impact questionnaire and Nottingham Health Profile were used at baseline and at the end of treatments.
Significant improvements were found in both groups for all parameters. However, the scores for pain-pressure threshold were significantly elevated and the symptoms of anxiety were
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significantly diminished in the exercise group compared to the massage group. Thus, exercise and massage might be used to provide improvements in women with fibromyalgia. The exercise group showed more advantages than massage group and thus might be preferred for patients with
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fibromyalgia. However, an adequately powered trial is required to determine this with certainty.
Revised 02 Sep 2015 Accepted 07 Sep 2015
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CONTACT Gamze Ekici
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Received 26 Jun 2014
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E-mail: [email protected]
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Faculty of Health Science, Hacettepe University, 06100, Samanpazarı-Ankara, Turkey.
INTRODUCTION
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KEYWORDS: fibromyalgia, connective tissue massage, Pilates exercises, anxiety, quality of life
The etiology of Fibromyalgia (FM) is not known (Balasubramaniam et al., 2007). However, both somatic and psychological factors play a role in the development and persistence of FM (Wolfe et al., 1990). Moreover, mounting data have suggested an overlap between FM and psychiatric conditions, including depression and anxiety (Amital et al., 2006). Anxiety disorders have
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increasingly been identified as co-morbid psychiatric concerns in patients with chronic pain (Williams, 2003). In addition, chronic pain seriously affects Health Related Quality of Life (HRQoL). FM is a complex syndrome, associated with significant functional and HRQoL
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impairments (Breivik et al., 2006). FM also occurs more frequently among females than males
Treatment of FM is difficult (Goldenberg et al., 2004). Conventional treatments do not
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appear to manage the problem effectively, which has led to alternative forms of treatment (Quinna et al., 2007). The aim of treating FM is to decrease pain and increase function by means
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of a multimodal therapeutic strategy which, in most cases, includes pharmacologic and nonpharmacologic interventions (Sarzi-Puttini et al., 2007; Bieber et al., 2006; Wolfe et al., 1997). Examples of non-pharmacologic treatment approaches for FM have included exercise, electrotherapy, patient education, self-management programs (Sim and Adams, 1999), massage
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techniques, cryotherapy, and acupuncture (Offenbacher and Stuck, 2000; Çıtak-Karakaya et al.
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2006). Patients choose these non-pharmacologic approaches for a number of reasons, including dissatisfaction with conventional treatments and/or concerns over the toxicity of drugs (Quinna
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et al., 2007). However, consensus has not been reached about which treatment approach is the best.
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(Amital et al., 2006).
Previous studies have examined Pilates Exercises (PE) for chronic pain and have shown
the effectiveness of PE for osteoarthritis (Yakut et al., 2006), ankylosing spondylitis (Roşu et al., 2013) and non-specific low back pain (Donzelli et al., 2006). Also, the first clinical study which
showed the effects of PE for FM was reported in 2009 (Altan et al., 2009).
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PE can be defined as a comprehensive body–mind conditioning, the main goals of which are efficient movement, core stability and enhanced performance (Sperling de Souza and Vieira, 2006; Akuthota and Nadler, 2004; Blum, 2002; Anderson and Spector, 2000; Muscolino and
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Cipriani, 2004). In other words, PE was developed to create a healthy body, a healthy mind and a
includes physical and mental conditioning and provides thorough training to improve strength,
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flexibility, balance and postural awareness by stretching and strengthening exercises (Blum, 2002).
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Connective Tissue Massage (CTM) is a manipulative therapy in which the connective tissue reflex zones are stimulated by a gentle shear force in a specific sequence with the aim of reducing pain, restoring balance in the autonomic nervous system and inducing segmental and
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suprasegmental reflex effects on the visceral and hormonal systems (Çıtak-Karakaya et al. 2006; Ebner, 1978; Goats and Keir, 1991; Holey, 2000; Holey, 1995). Physical and emotional
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symptoms have been improved by CTM in individuals with FM (Çıtak-Karakaya et al. 2006;
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Brattberg, 1999).
The current randomized controlled pilot trial was undertaken to assess and compare the
effectiveness of PE, an active-group therapy, and CTM, a passive-personalized therapy, in the
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healthy life. Its philosophy integrates the mind with the musculoskeletal system. Thus, PE
management of FM in females.
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METHODS
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Participants
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Medicine, Ankara, Turkey and was conducted in accordance with the rules of the Declaration of
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Helsinki. It was also registered with the clinical trial registry. Written and oral information was given to all patients before testing. All participants gave their informed written consent for was conducted between January and August 2013. Patients
were
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participation. The trial
eligible for the study if they met the following inclusion criteria: being female (FM occurs more frequently in females than males (Amital et al., 2006), so only the female patients were recruited in this study); being over 25 years old, meeting the criteria for FM as defined by the American
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College of Rheumatology (ACR) (Wolfe et al., 1990), having moderate pain (>5 based on Visual Analogue Scale (VAS)) before the baseline visit having pain in the neck and shoulder region,
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and never having been treated for FM.
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The criteria for exclusion were: infection, fever, increased tendency to bleed, severe
physical impairment, inflammatory disease, cardiopulmonary disorders, uncontrolled endocrine disorders, allergic disorders, pregnancy, malignancy, severe psychiatric illnesses, and factors
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This study protocol was approved by the Ethics Committee of Hacettepe University, Faculty of
known to affect autonomic function or medication usage. The participants were asked not to use any analgesics, muscle relaxants, non-steroidal anti-inflammatories and anti-depressants during the three days before the first appointment, during the treatment and at the end of the treatment.
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Participants were selected according to the eligibility criteria from the outpatients seen during the study period who were directed by the clinicians to the Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Hacettepe University, Ankara. The sample was
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derived from a population of 74 FM outpatients. Thirty-one of the patients were not included due
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Assignment to Treatment Groups
Patients who met the inclusion criteria were randomly assigned to one of two groups. The
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assignment of the treatment procedure for the first participant was determined by a closed envelope that included a letter. Two letters indicated the different treatment approaches: PE and CTM. The first participant chose a letter that assigned her to one of these treatments and included instructions for one of the treatment procedures and the name of the treatment provider.
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For the first selection, the fourth researcher did not know which treatment was selected by the participant and asked the participant to tell her to which therapy group she had been assigned.
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After this, women who met the entry criteria were randomly assigned in a 1:1 ratio to one of the
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two treatment groups, PE or CTM, by the fourth researcher, who took a random envelope from the box with sealed envelopes. These women were also given a letter; but this time the fourth researcher had knowledge about the content of the letters.
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to meeting the exclusion criteria (Figure 1).
Twenty-one FM patients were
assigned the PE program, and 22 were assigned to receive CTM. PE was organized by the first researcher, and CTM was applied by second researcher. Only the third researcher who assessed the participants before and after the treatments was masked as to the treatment group assignments of each participant. Each group received the assigned treatment three times per
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week during a four-week period. Both the PE and CTM were performed by two experienced physiotherapists (PTs); each had a minimum of 16 years of clinical experience.
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Interventions
certified and experienced trainer. This treatment group consisted of 20 minutes of warm up and
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cool down (10 minutes before and 10 minutes after the exercises) and 40 minutes of PE. PE activity level was increased gradually, from 5 repetitions to 10. In the second week participants
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performed one repetition; in the third and fourth weeks, two repetitions were added to the ongoing exercises, and also new, higher-level exercises were added according to the group progress.
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CTM was applied in a sitting position, without back support. The thighs and feet were fully supported. A pillow was placed on the participant’s lap for forearm support. The backs of the
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participants were bare and straight for optimal tension of the connective tissue. For creating traction between the cutaneous tissues, the middle fingers were used bilaterally (Brattberg,
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1999). CTM was started from the lumbo-sacral area (basic section) and progressed to the lower thoracic, scapular, inter-scapular, and cervico-occipital sections, according to the vascular
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Each session time was one hour per treatment in the PE group, which was conducted by a
response of the connective tissue. CTM took 5 to 20 minutes in each session, depending on the treated area.
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Outcome Measures All participants provided demographic data and the self-report questionnaires including: the
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State-Trait Anxiety Inventory (STAI) (Spielberger, 2005), the Nottingham Health Profile (NHP)
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pressure (PP) threshold, tolerance and pain intensity were also evaluated by algometry (Fryer and
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Hodgson, 2005) and a Visual Analogue Scale (VAS) (Breivik et al., 2006). All participants were assessed with all of these instruments again at the end of the study.
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Self-evaluation of the pain intensity was obtained by VAS ratings. The VAS was used to measure each patient’s average pain for the last month (Breivik et al., 2006). An algometry (J Tech USA) with a one cm2 tip was used to determine PP threshold and
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tolerance levels from the upper trapezius muscle bilaterally, which is one of the tender points used for diagnosis of FM (Wolfe et al., 1990; Fryer and Hodgson, 2005). Patients were instructed
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to indicate when they first perceived pain (threshold) and when the pain became unbearable
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(tolerance), and then the pressure was stopped (Akbayrak et al., 2002). The STAI is a 40-item self-report assessment that differentiates between state anxiety (S-
anxiety) and trait anxiety (T-anxiety). The Turkish-validated version of the STAI was used (Oner
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(Aksu et al., 2004), and the Fibromyalgia Impact Questionnaire (FIQ) (Bennett, 2005). Pain
and Le Compete, 1983). High scores indicate high anxiety (Spielberger, 2005). The Turkish-validated version of the FIQ was also used (Sarmer et al., 2000). The FIQ is a brief 10-item self-administered instrument. In the revised version of the FIQ, item 1 is about physical functioning. For items 2 and 3, patients indicated the number of days that they felt well
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or missed work because of FM symptoms. Items 4 through 10 are 10 cm VASs marked in onecm increments on which the patient rated work difficulty, pain, fatigue, morning tiredness, stiffness, anxiety and depression (Bennett, 2005). A higher value indicates a higher impact of the
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disorder.
into six areas of health: energy (NHP-E), pain (NHP-P), emotional reactions (NHP-ER), sleep
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(NHP-S), social isolation (NHP-SI) and physical mobility (NHP-PM). All the parameters are summed to obtain the NHP total (NHP TOT) (Aksu et al., 2004). The Turkish version of the
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NHP was administered (Küçükdeveci et al., 2000).
Measurements were performed for each participant two times: at baseline and end of treatments. The participants were examined individually in a test room by the third researcher
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Data Analyses
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who was masked as to treatment assignment of each participant.
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Data were analyzed by Statistical Package for the Social Sciences (SPSS) Version of 17. The results were expressed as mean±standard deviation (SD) of each score. The Wilcoxon Rank test was used to analyze the data from baseline and at the end of treatment. The Mann-Whitney U-
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The NHP is a self-administered, subjective health status questionnaire with 38 items, divided
test was used to examine differences in outcome measures between the groups at baseline and at the end of treatment. Significant differences were found in baseline values of NHP-SI, NHP-PM, NHP TOT and pain intensity between the groups. No differences between the groups were observed for other baseline charecteristics (Table 1) and FIQ scores (Table 2). Thus, no other
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potentially confounding variables, beyond the baseline values of the measures, were identified. Analyses were needed to determine which intervention was more effective, controlling for differences between the two treatment groups in the baseline values of the four measures of
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interest. Mann-Whitney U-tests were performed for the differences between all baseline and the
intervention. In addition, analyses were undertaken to determine which intervention was more
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effective by eliminating the effects that could result from differences in baseline values of the four measure of interest. These analyses were undertaken for all parameters in this study.
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Because these variables were not normally distributed, non-parametric Quade’s rank analysis of covariance test was used for controlling the effect of baseline values for NHP-SI, NHP-PM, NHP TOT and pain intensity when examining differences between groups in the change in the values
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RESULTS
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for these measures. Level of significance was accepted at 0.05.
The average age and educational attainment of the PE participants were 37.13±6.37 and
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12.60±5.03 years; in the CTM group they were 36.86±7.73 and 12.71±5.10 years, respectively. No significant differences were observed in age, educational attainment , height, weight or body
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end of treatment values in each group to show the amount of the change associated with each
mass index (BMI) at baseline (Table 1). Also, 17 (47.2 %) of the participants were married; 12 (33.3 %) were single, and 7 (19.4 %) were divorced. Six participants could not complete
(unwillingness to continue n = 3, health problem n = 1, unknown n = 2) the Pilates exercise program. One participant dropped out from the CTM group (Figure 1), resulting in differences in
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the numbers of participants in the two groups and suggesting greater difficulty in compliance with the Pilates treatment that with the CTM. The baseline values of some subitems of the NHP (NHP-E, NHP-P, NHP-ER and NHP-S), Pain
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pressure, STAI and FIQ did not differ significantly between the intervention groups. However,
NHP-SI (p = .005), NHP-PM (p = .001), NHP-TOT (p = .03) and in the VAS (p = .009) (Table
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2).
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In unadjusted analyses, scores at the end of treatment did not differ between the treatment groups for the VAS and NHP, including energy, pain, emotional reactions, social isolation, sleep, and physical mobility sub-items, which were decreased in both groups (p>0.05). Scores of PP threshold and tolerance increased in both treatment groups, but no difference in overall PP was
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found between the groups. However, the PP threshold of the right (p = .031) and left (p = .014) trapezius were significantly elevated in the PE group compared to CTM group at the end of
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treatment. The unadjusted scores obtained from the State-anxiety and Trait-anxiety decreased in
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both groups, and the State-anxiety was significantly lessened in the PE group compared to the CTM group at the end of treatment (p = .008). Also, the unadjusted scores of the FIQ-9 were significantly decreased in the PE group compared to the CTM group (p = .019) at the end of the
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significant differences between the two treatment groups were found in the baseline values of
treatment (Table 2). We found significant differences in baseline values of NHP-SI, NHP-PM,
NHP TOT and pain intensity between the groups. These differences in baseline values between the groups could have partially accounted for the differences in changes in the scores from preto post-treatment between the groups. The differences of end of treatment values of NHP-SI,
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NHP-PM, NHP TOT and pain intensity between the groups were also analyzed by controlling the effect of pre-treatment values, because they differed between the groups, using the nonparametric Quade’s rank analysis of covariance test. According to Quade’s rank analysis of
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covariance test results, no significant differences were observed between the groups in NHP-SI
between the groups were found in end of treatment values of NHP-PM (p = .001) and NHP TOT
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(p = .034) after controlling for differences between groups in their baseline values. The mean post-treatment values were lower in PE group than in the CTM group (Table 2).
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When the baseline and end of treatment scores were compared, the unadjussted mean FIQ total score significantly decreased for both the PE group and CTM group (p = .001 and p = .001; Wilcoxon test) (Table 3). Thus, both PE and CTM led to significant and progressive
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improvements in overall symptomatology by the end of the treatment, according to the FIQ total score. Except for the FIQ-1 and FIQ-3 for the CTM group (p = .202 and p = .221, Wilcoxon
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(Table 3).
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test), the improvement was significantly greater in the sub-items of the FIQ with treatment
Consequently, we also analyzed differences between the baseline and end of treatment values of all parameters to investigate the effectivenesses of the interventions. Both the unadjusted and
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(p = .667) and pain intensity (p = .734) end of treatment values. However, significant differences
adjusted (for baseline values) mean differences between the baseline and end of treatment values
were calculated for the four outcome variables (pain intensity, NHP- social isolation, physical mobility, and total). The adjusted differences between the baseline and end of treatment values were larger in the PE group than in the CTM group for pain intensity (p = .009), right and left PP
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threshold (p = .007 and p = .002), state and trait anxiety (p = .016 and p = .011), NHP-pain (p = .027), social isolation (p = .005), physical mobility (p = .001) and total (p = .030), FIQ-9 (p =
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.002) and FIQ-10 (p = .006) (Table 4).
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The results of this study have demonstrated that PE and CTM may be used to provide
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improvements in females with FM. To date, this is the first controlled trial of which we are
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aware to compare the effectiveness of PE, a popular-active-group therapy, and CTM, a manualpassive-personalized therapy, in the treatment of FM.
We found limited numbers of randomized controlled trials of PE in the literature. Yakut et al. determined that PE had positive effects on chronic pain in osteoarthritis (Yakut et al.,2006).
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Donzelli et al. suggested the use of PE as an alternative approach to the treatment of non-specific low back pain (Donzelli et al., 2006). Mannerkorpi and Iversen emphasized that patients with
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FM may improve their aerobic capacity and physical function and diminish their tenderness if
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they exercise at a moderate intensity at least twice per week (Mannerkorpi and Iversen, 2003). Altan et al. found that PE was an effective and safe method for the people with FM (Altan et al., 2009).
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DISCUSSION
In the present study, the participants were predominantly physically inactive. Before the
PE, most of them thought that exercise created more pain, but the researchers encouraged and told them that this has not been shown in the literature. Moreover, pain and disability reduction were their goals. They were also interested in improving their posture and flexibility. At the end
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of this study, the patients in PE group changed their minds, and they had much more confidence that they could use their muscles without pain. In 1991, Goats and Keir determined that CTM increased blood flow and gave pain relief (Goats
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and Keir, 1991). McKechnie et al. showed that CTM could reduce tension and anxiety
decreasing stress hormones and muscle tension and increasing pain thresholds (Brattberg, 1999).
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CTM is thought to be an effective method that produces general body relaxation, reduces muscle spasm and connective tissue tenderness, and increases plasma β endorphins (Çıtak-Karakaya et
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al. 2006). CTM has also positive effects on autonomic responses (Çıtak-Karakaya et al. 2006; Goats and Keir, 1991). Brattberg found that as long as effective medical treatment is lacking for individuals with FM, treatment with CTM should be offered (Brattberg, 1999). CTM and
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combined ultrasound therapy has also been helpful in improving pain intensity, complaints of nonrestorative sleep, and functional activities in patients with FM (Çıtak-Karakaya et al. 2006).
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Chronic pain in FM can cause prevalent and important psychological problems, such as
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anxiety. Anxiety is an emotion that influences the perception of pain, as it tends to lower both PP threshold and tolerance (Williams, 2003; Goats and Keir, 1991). It is an emotional disorder frequently encountered in women with FM. Coexistent anxiety is a significant predictor of
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(McKechnie et al., 1983). In addition, touching the skin in itself has positive effects by
functional impairment in FM patients (Amital et al., 2006). Also, chronic pain is the most frequent cause of disability and seriously affects the HRQoL of millions of human beings. Actually, a close relation has been shown among pain, psychosocial health and health-related quality of life (HRQoL) (Ekici and Akbayrak, 2007). Consequently, while planning treatment
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programs, these relationships must be taken into account. In this study, pain intensity and the symptoms of anxiety were decreased, and HRQoL was supported in both groups. The reduction in State-anxiety and Trait-anxiety reactions were also significant in our
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results, confirming the association of both variables (Pain and anxiety), which were noted in this
anxiety in both groups; however, the PE group showed much more effectiveness in reducing
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anxiety compared to CTM. The results of this study identified that mental and physical relaxation, isolation of each part of each exercise, visual imagination and breathing controls in
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PE had positive effects on emotional relief as a mind-body therapy (Yakut et al., 2006). Also, after controlling for the significant differences in baseline values between the groups, the physical mobility and HRQoL level were found to be more improved in the PE group than CTM
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group. Additionally, the originality and variety of the exercises may have encouraged a more proactive and trusting attitude toward the program (Donzelli et al., 2006). The originality of the
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Pilates method stimulated the patients’ interest in this technique. However, these are only subjective observations that need further investigation and confirmation in larger randomized
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controlled trials.
A majority of FM patients report pain and stiffness in the neck-shoulder muscles, and a
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type of patients (Spielberger, 2005). In this study, significant improvements were found in
majority develop FM from localized or regional muscle pain conditions, such as trapezius myalgia (Sandberg et al., 2005). Our clinical experience also indicated that the trigger points of the trapezius were highly painful in FM patients. This is why the trapezius was chosen for
assessing the PP threshold and tolerance in the current study. The scores for PP threshold and
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tolerance were increased in both groups at the end of the treatment. Nevertheless, the PP threshold level in the PE group was higher than CTM group after treatment. PE and CTM support HRQoL according to the NHP, in terms of feelings of social
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isolation, physical mobility, energy level, sleep disturbances and emotional reaction in this
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FIQ in both treatment groups.
The results of this study confirmed previous published studies (Çıtak-Karakaya et al.
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2006; Brattberg, 1999) for the efficacy of CTM in treating FM as indicated by a reduction in the VAS, NHP and FIQ. Similarly, good results were obtained with PE; however, PE was more efficacious than CTM in terms of the PP threshold and anxiety.
A possible explanation is that Pilates is composed of active, simple and easily adaptable
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exercises; however, CTM is a personalized and passive treatment approach. Also, a major
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difference between interventions was the use of the group setting for Pilates; thus, the treatment effect could also be from the group interaction or both the interaction and the treatment. It was
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not possible to separate the effects of treatment from those of the group interaction in the current study design.
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current work. Improvements were also found in multiple dimensions of progress based on the
In conclusion, these results suggest that PE and CTM may be of benefit in the treatment of FM and may also have some wider benefits in terms of HRQoL. These results are encouraging. However, PE had more effectiveness on anxiety symptoms and PP threshold than CTM in the current pilot study. The study did have some limitations worth noting in interpreting the results.
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First, because the sample size was small, inadequate statistical power resulted, making it difficult to explain which approach was more beneficial for FM because we had insufficient statistical power to detect some meaningful differences as statistically significant. In the group therapies,
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more patients can benefit from the treatment at the same time. Also, exercise should become a
preferred by the PTs. However, the second main limitation of the study was the unwillingness of
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patients to continue in the groups, especially for PE, making the acceptability and applicability of these methods questionable. A third limitation was that although many active and passive
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therapy techniques could be used for FM, as an active intervention PE and as a passive intervention CTM were selected in this study; this, combined with the sample being restricted to one study site, results in the generalizability of results being limited. Additionally, participants were unequally distributed between the groups due to lower compliance and completion in the
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PE group (in PE group n = 15, in CTM group n = 21). Also, the study did not include long-term follow-up to assess for the durability of effects. Further, because this study included only
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women, these results cannot be extended to men with FM.These results indicated that different
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approaches can be used for treatment of FM. Furthermore, harmonizing the approaches according to the patients’ needs may be the best for obtaining the optimal outcome. Despite the theoretical basis and observational positive results, future research with larger sample sizes and
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part of the treatment plan for people with FM. Because PE has some advantages, it may be
using a randomized controlled design is required to determine the effectiveness of PE and CTM as therapeutic interventions. The current pilot study may highlight preliminary results for further studies on this subject. Also, further studies should be carried out larger number of groups, male patients and long-term follow-up results.
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related syndromes. Best Pract Res Clin Rheumatol 17(4): 649-665.
22
CTM Group (n = 21)
z
Age (years)
37.13±6.37
36.86±7.73
-0.225
Height (meter)
1.61±0.05
1.63±0.07
(kilogram)
Body
Mass
Index
.822
cr ip
60.00±3.48
-0.805
60.00±8.85
23.23±2.25
ce
pt
PE: Pilates Exercises, CTM: Connective Tissue Massage.
23
.421
.573 -0.564
22.48±3.12
ed
(kg/m²)
us
Weight
M an
Body
p
t
PE group (n = 15)
Ac
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Table 1. Baseline characteristics of the sample (mean ± SD).
.619 -0.497
Table 2. Comparison of the Nottingham Health Profile, Pain Intensity, Pain Pressure, State-Trait Anxiety Inventory, and Fibromyalgia Impact Questionnaire scores of PE and CTM groups at baseline and at the end of treatment (mean±SD) CTM
baseline
z and p
PE group
CTM
z and p
value for
end of
group end
values for
differences
treatment
baseline between (n = 15)
value
of
differences
treatment
between
(n=15)
us
groups at
groups at
(n=21)
(n = 21)
ce
Energy
56.59±24.5
52.99±29.75
7
Pain
z
p
-
.566
treatment
Mean± SD Mean± SD
z
p
3.36±30.4
27.58±34.
-
.890
3
80
0.13
pt
Health Profile
Mean±SD
end of
ed
Nottingham
baseline
M an
Mean± SD
0.57
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value
cr ip
group
t
PE group
66.92±12.2
4
56.35±28.44
8
-
.268
1.10
24
12.21±11.
18.10±14.
1.12
.263
1
8
Emotional
46.60±24.9
reactions
9
38.24±32.81
-
.335
96
37
0
8.73±9.22
13.10±16.
-
41
0.19
t
0.96
Isolation
2
-
.005
2.84
*
Sleep
37.44±30.9
Total
20.14±15.47
3
ce
Mobility
43.39±22.5
pt
Physical
28.24±27.49
-
3.98±10.4
4
.361
6.95±8.01
8
5.22±8.80
.667
0.18 8ª
-
0.91
0.98
3
1
ed
2
9.11±10.2
M an
0
cr ip
16.76±25.99
9
us
43.32±31.1
-
.001
3.28
*
8.67±6.00
12.80±12. 23
.326
.001 17.7
*
4ª
1
294.25±90.
212.73±124.
-
.030
69.03±38.
80.79±64.
.034
21
50
2.16
*
34
73
*
Ac
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4
Social
.842
6
4.85ª
25
8.75±0.91
Pain
6.62±2.45
.009
intensity (0-
0.11
0
7ª
cr ip us
pressure
1.43±0.30
Tolerance
(right side)
1.64±0.55
pt
1.53±0.34
ce
(left side)
1.51±0.46
-
-
.031
0.32
2.15
*
5
8
ed
(right side)
M an
(kg/cm2)
5.09±0.77
Ac
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*
Pain
Threshold
.734
2.62
10cm)
Threshold
2.53±2.16
t
(VAS)
-
2.15±0.90
5.17±1.41
.745
-
.617
2.75±0.52
-
.014
0.50
2.46
*
0
0
-
.772
3.03±0.61
2.30±0.76
6.13±1.26
2.47±0.90
6.23±1.28
1.00
0.28
0.00
9
0
26
0
Tolerance
4.47±0.65
5.16±1.62
.563
5.71±1.00
6.38±1.41
-
0.57
1.47
9
7
.140
cr ip
t
(left side)
-
Anxiety
47.73±10.6
Anxiety
7
48.33±12.56
-
.846
32.33±7.2
41.81±12.
-
.008
5
50
2.66
*
M an
State-
us
Inventory
0.19 5
55.07±6.43
50.71±10.63
ed
Trait-
.209
1.25 5
Fibromyalg ia
4
45.33±7.9
46.05±7.5
-
5
5
0.25 8
ce
pt
Anxiety
-
Impact
Ac
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State-Trait
Questionnai re
27
.796
1 Physical
2.54±1.96
2.47±1.84
.796
1.06±0.99
2.05±1.59
-
0.25
1.92
9
6
.054
4.58±3.07
4.56±2.74
good
-
.947
0.06
Work
1.62±1.78
missed
Work
6.53±2.36
6.05±2.98
ce
pt
impairment
5 Pain
6 Fatigue
-
6.80±2.65
6.38±2.67
7.80±1.56
6.57±2.93
-
.101
0.48±1.03
0.36±1.12
0.71
8
3
-
.662
2.10±1.78
2.64±2.34
-
0.43
0.58
7
3
-
.627
2.43±1.21
3.38±2.22
-
0.48
1.13
6
2
-
.324
0.98
28
.159
0
1.63
ed
4
0.79±1.64
3.06±1.99
1.41
M an
3
2.19±1.31
us
6
Ac
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2 Days felt
cr ip
t
impairment
-
4.17±1.72
4.12±2.58
0.42
.476
.560
.258
.674
7
5.77±3.23
6.45±2.98
tiredness
-
.488
2.83±1.23
0.69
.266
7.40±2.23
6.26±2.76
-
6.37±2.42
ce
Depression
Total
5.14±3.23
pt
10
55.12±10.0 7
50.20±22.46
3.69±2.85
.244
0.84 0
1.16
2.34
*
4
9
.295
1.23±0.73
3.88±2.93
.401
.019
-
1.63±0.79
-
-
ed
9 Anxiety
4.17±1.77
M an
3
cr ip
-
us
5.71±3.36
.064
1
1.11
Ac
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7.27±1.62
1.85
4
8 Stiffness
4.67±2.73
t
7 Morning
0
2.98±2.50
-
1.04
1.69
8
9
0.22 9
.229
22.12±4.5
28.68±14.
0.20
8
22
5
*p < .05. PE: Pilates Exercises, CTM: Connective Tissue Massage.
29
.089
.205
Possible range of Nottingham Health Profile and subgroup scores: Energy: 0-100, Pain: 0-100, Emotional reactions: 0-100, Social Isolation: 0-100, Sleep: 0-100, Physical Mobility: 0-100, Total: 0-600.
t cr ip
Possible range of State-Trait Anxiety Inventory scores: State-Anxiety: 20-80, Trait-Anxiety: 20-
us
80.
Possible range of Fibromyalgia Impact Questionnaire (FIQ) and subgroup scores: 1 Physical
M an
impairment; 2 Days felt good; 3 Work missed; 4 Work impairment; 5 Pain; 6 Fatigue; 7 Morning tiredness; 8 Stiffness; 9 Anxiety; 10 Depression: 0-10 (each one). Total: 0-100. ª : Quade’s rank analysis of covariance test was used, to control for the significant difference
ce
pt
ed
observed between groups in the baseline values.
Ac
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Possible range of pain intensity: 0-10 cm.
30
Table 3. Comparison of the baseline and end of treatment scores of the Nottingham Health Profile, Pain Intensity, Pain Pressure, State-Trait Anxiety Inventory, and Fibromyalgia Impact
z and p
baseline
end of
value for
CTM
CTM
t
PE group
z and p
cr ip
PE group
group end
value for
of
differences
group value
treatment
differences between
us
baseline
treatment
between
value
and end of
treatment
treatment
z
p
Mean±SD
Mean± SD
z
p
52.99±29.75
27.58±34.
-
.003
80
2.98
*
ce
Profile
and end of
pt
Nottingham Health
Mean± SD
baseline
ed
Mean± SD
M an
baseline
Ac
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Questionnaire (mean±SD)
Energy
56.59±24.5
23.36±30.
-
.003
7
43
2.94
*
7
8
31
Pain
66.92±12.2
12.21±11.
-
.001
1
96
3.40
*
56.35±28.44
18.10±14.
-
.001
37
4.01
*
5
reactions
9
8.73±9.22
-
.001
3.18
*
0
43.32±31.1
9.11±10.2
-
.001
2
4
3.18
*
Isolation
38.24±32.81
16.76±25.99
M an
Social
cr ip
46.60±24.9
13.10±16.
-
.002
41
3.12
*
us
Emotional
37.44±30.9
ce
pt
2
6.95±8.01
Physical
43.39±22.5
Mobility
3
Total
-
.003
2.93
*
ed
Sleep
8.67±6.00
294.25±90.
28.24±27.49
-
.037
8
2.08
*
1
5.22±8.80
4
-
.001
3.29
*
-
-
.001
3.18
*
7
20.14±15.47
12.80±12.
-
.004
23
2.85
*
6
69.03±38.
5
3.98±10.4
4
Ac
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t
8
2
.001
3.40
212.73±124.
80.79±64.
4.01
32
.001
Pain
21
34
8.75±0.91
2.15±0.90
50
73
.001
6.62±2.45
2.53±2.16 -
t 5
1.43±0.30
2.75±0.52
-
.001
3.41
*
1.51±0.46
2.30±0.76
ed
(right side)
M an
(kg/cm2)
pt
5
1.53±0.34
3.03±0.61
ce
(left side)
Tolerance
(right side)
*
cr ip
1
pressure
Threshold
.001
4.01
Pain
Threshold
*
us
10cm)
5
*
3.41
(0-
Ac
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*
-
intensity (VAS)
8
5.09±0.77
.001
4.02
*
1
-
.001
3.41
*
1.64±0.55
2.47±0.90
3
6.13±1.26
-
-
.001
4.02
*
0
-
.001
3.40
*
9
5.17±1.41
6.23±1.28
-
.001
3.92
*
3
33
Tolerance
4.47±0.65
5.71±1.00
(left side)
-
.001
3.41
*
5.16±1.62
6.38±1.41
.001
3.89
*
6
Anxiety Inventory
47.73±10.6
32.33±7.2
-
.001
7
5
3.41
*
Anxiety
48.33±12.56
M an
State-
41.81±12.
-
.002
50
3.04
*
0
55.07±6.43
45.33±7.9
-
.001
5
3.30
*
ed
Trait-
5
Fibromyalg ia
50.71±10.63
5
46.05±7.5
-
.001
5
3.38
*
8
ce
pt
Anxiety
Impact
Ac
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State-Trait
us
cr ip
t
2
-
Questionnai re
34
1
Physical
2.54±1.96
1.06±0.99
impairment
-
.005
2.81
*
2.47±1.84
2.05±1.59
-
.221
1.22 4
2.19±1.31
good
-
.011
2.55
*
5
Work
1.62±1.78
missed
0.48±1.03
-
.010
2.58
*
0.79±1.64
M an
3
4.56±2.74
3.06±1.99
us
4.58±3.07
0.36±1.12
Work
6.53±2.36
2.10±1.78
ce
pt
impairment
5 Pain
6 Fatigue
-
.001
3.23
*
ed
4
6.80±2.65
2.43±1.21
7.80±1.56
6.05±2.98
2.64±2.34
9
2.22
*
0
-
.202
-
.001
3.66
*
9
-
.001
3.18
*
-
.026
6
6.38±2.67
3.38±2.22
4
4.17±1.72
-
1.27
5
Ac
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2 Days felt
cr ip
t
0
-
.001
3.23
*
9
.001
3.19
6.57±2.93
4.12±2.58
2.87
35
.004
tiredness
-
.005
2.81
*
7.27±1.62
4.17±1.77
-
.001
3.30
*
7.40±2.23
5.71±3.36
M an
9 Anxiety
1.63±0.79
4.67±2.73
-
.001
3.41
*
3.69±2.85
6.26±2.76
3.88±2.93
ed
1
6.37±2.42
ce
Depression
Total
1.23±0.73
pt
10
-
.007
2.70
*
6
9
-
.001
3.41
*
5.14±3.23
-
.013
2.48
*
9
-
.008
2.63
*
8
2.98±2.50
0
-
.007
2.68
*
2
55.12±10.0
22.12±4.5
-
.001
7
8
3.40
*
Ac
Downloaded by [University of California, San Diego] at 15:49 18 February 2016
8
8 Stiffness
6.45±2.98
*
t
2.83±1.23
9
cr ip
5.77±3.23
*
us
7 Morning
3
50.20±22.46
8
28.68±14.
-
.001
22
3.38
*
9
* p
ISSN: 0363-0242 (Print) 1541-0331 (Online) Journal homepage: http://www.tandfonline.com/loi/wwah20
Effects of Active/Passive Interventions on Pain, Anxiety and Quality of Life in Women with Fibromyalgia: Randomized Controlled Pilot Trial Gamze EKİCİ PT, PhD, Edibe Unal PT, PhD, Turkan Akbayrak PT, PhD, Naciye Vardar-Yagli PT, PhD, Yavuz Yakut PT, PhD & Erdem Karabulut PhD To cite this article: Gamze EKİCİ PT, PhD, Edibe Unal PT, PhD, Turkan Akbayrak PT, PhD, Naciye Vardar-Yagli PT, PhD, Yavuz Yakut PT, PhD & Erdem Karabulut PhD (2016): Effects of Active/Passive Interventions on Pain, Anxiety and Quality of Life in Women with Fibromyalgia: Randomized Controlled Pilot Trial, Women & Health, DOI: 10.1080/03630242.2016.1153017 To link to this article: http://dx.doi.org/10.1080/03630242.2016.1153017
Accepted author version posted online: 16 Feb 2016.
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Date: 18 February 2016, At: 15:49
Effects of active/passive ınterventions on pain, anxiety and quality of life in women with fibromyalgia: Randomized controlled pilot trial
cr ip
t
Gamze Ekici, PT, PhD
Edibe Unal, PT, PhD, Turkan Akbayrak, PT, PhD, Naciye Vardar-Yagli, PT, PhD, and Yavuz Yakut, PT, PhD
us
Department of Physiotherapy and Rehabilitation, Faculty of Health Science, Hacettepe University, Ankara, Turkey
M an
Erdem Karabulut, PhD
Department of Biostatistics, Faculty of Medicine, Hacettepe University, Ankara, Turkey Abstract
ed
This study was compared the effects of Pilates exercises and connective tissue massage (CTM) on pain intensity, pain-pressure threshold and tolerance, anxiety, progress, and health-related
pt
quality of life in females with fibromyalgia. It was a pilot, assessor masked, randomized controlled trial conducted between January and August 2013. Twenty-one women with
ce
fibromyalgia were randomly assigned to the pilates exercise program (six of whom did not complete the program), and 22 were randomly assigned to CTM (one of whom did not complete this program). Each group received the assigned intervention three times per week during a four-
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Faculty of Health Science, Hacettepe University, Ankara, Turkey
week period. Visual analogue scale, algometry, state-trait anxiety inventory, fibromyalgia impact questionnaire and Nottingham Health Profile were used at baseline and at the end of treatments.
Significant improvements were found in both groups for all parameters. However, the scores for pain-pressure threshold were significantly elevated and the symptoms of anxiety were
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significantly diminished in the exercise group compared to the massage group. Thus, exercise and massage might be used to provide improvements in women with fibromyalgia. The exercise group showed more advantages than massage group and thus might be preferred for patients with
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fibromyalgia. However, an adequately powered trial is required to determine this with certainty.
Revised 02 Sep 2015 Accepted 07 Sep 2015
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CONTACT Gamze Ekici
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Received 26 Jun 2014
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E-mail: [email protected]
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Faculty of Health Science, Hacettepe University, 06100, Samanpazarı-Ankara, Turkey.
INTRODUCTION
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KEYWORDS: fibromyalgia, connective tissue massage, Pilates exercises, anxiety, quality of life
The etiology of Fibromyalgia (FM) is not known (Balasubramaniam et al., 2007). However, both somatic and psychological factors play a role in the development and persistence of FM (Wolfe et al., 1990). Moreover, mounting data have suggested an overlap between FM and psychiatric conditions, including depression and anxiety (Amital et al., 2006). Anxiety disorders have
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increasingly been identified as co-morbid psychiatric concerns in patients with chronic pain (Williams, 2003). In addition, chronic pain seriously affects Health Related Quality of Life (HRQoL). FM is a complex syndrome, associated with significant functional and HRQoL
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impairments (Breivik et al., 2006). FM also occurs more frequently among females than males
Treatment of FM is difficult (Goldenberg et al., 2004). Conventional treatments do not
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appear to manage the problem effectively, which has led to alternative forms of treatment (Quinna et al., 2007). The aim of treating FM is to decrease pain and increase function by means
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of a multimodal therapeutic strategy which, in most cases, includes pharmacologic and nonpharmacologic interventions (Sarzi-Puttini et al., 2007; Bieber et al., 2006; Wolfe et al., 1997). Examples of non-pharmacologic treatment approaches for FM have included exercise, electrotherapy, patient education, self-management programs (Sim and Adams, 1999), massage
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techniques, cryotherapy, and acupuncture (Offenbacher and Stuck, 2000; Çıtak-Karakaya et al.
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2006). Patients choose these non-pharmacologic approaches for a number of reasons, including dissatisfaction with conventional treatments and/or concerns over the toxicity of drugs (Quinna
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et al., 2007). However, consensus has not been reached about which treatment approach is the best.
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(Amital et al., 2006).
Previous studies have examined Pilates Exercises (PE) for chronic pain and have shown
the effectiveness of PE for osteoarthritis (Yakut et al., 2006), ankylosing spondylitis (Roşu et al., 2013) and non-specific low back pain (Donzelli et al., 2006). Also, the first clinical study which
showed the effects of PE for FM was reported in 2009 (Altan et al., 2009).
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PE can be defined as a comprehensive body–mind conditioning, the main goals of which are efficient movement, core stability and enhanced performance (Sperling de Souza and Vieira, 2006; Akuthota and Nadler, 2004; Blum, 2002; Anderson and Spector, 2000; Muscolino and
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Cipriani, 2004). In other words, PE was developed to create a healthy body, a healthy mind and a
includes physical and mental conditioning and provides thorough training to improve strength,
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flexibility, balance and postural awareness by stretching and strengthening exercises (Blum, 2002).
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Connective Tissue Massage (CTM) is a manipulative therapy in which the connective tissue reflex zones are stimulated by a gentle shear force in a specific sequence with the aim of reducing pain, restoring balance in the autonomic nervous system and inducing segmental and
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suprasegmental reflex effects on the visceral and hormonal systems (Çıtak-Karakaya et al. 2006; Ebner, 1978; Goats and Keir, 1991; Holey, 2000; Holey, 1995). Physical and emotional
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symptoms have been improved by CTM in individuals with FM (Çıtak-Karakaya et al. 2006;
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Brattberg, 1999).
The current randomized controlled pilot trial was undertaken to assess and compare the
effectiveness of PE, an active-group therapy, and CTM, a passive-personalized therapy, in the
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healthy life. Its philosophy integrates the mind with the musculoskeletal system. Thus, PE
management of FM in females.
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METHODS
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Participants
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Medicine, Ankara, Turkey and was conducted in accordance with the rules of the Declaration of
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Helsinki. It was also registered with the clinical trial registry. Written and oral information was given to all patients before testing. All participants gave their informed written consent for was conducted between January and August 2013. Patients
were
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participation. The trial
eligible for the study if they met the following inclusion criteria: being female (FM occurs more frequently in females than males (Amital et al., 2006), so only the female patients were recruited in this study); being over 25 years old, meeting the criteria for FM as defined by the American
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College of Rheumatology (ACR) (Wolfe et al., 1990), having moderate pain (>5 based on Visual Analogue Scale (VAS)) before the baseline visit having pain in the neck and shoulder region,
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and never having been treated for FM.
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The criteria for exclusion were: infection, fever, increased tendency to bleed, severe
physical impairment, inflammatory disease, cardiopulmonary disorders, uncontrolled endocrine disorders, allergic disorders, pregnancy, malignancy, severe psychiatric illnesses, and factors
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This study protocol was approved by the Ethics Committee of Hacettepe University, Faculty of
known to affect autonomic function or medication usage. The participants were asked not to use any analgesics, muscle relaxants, non-steroidal anti-inflammatories and anti-depressants during the three days before the first appointment, during the treatment and at the end of the treatment.
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Participants were selected according to the eligibility criteria from the outpatients seen during the study period who were directed by the clinicians to the Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Hacettepe University, Ankara. The sample was
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derived from a population of 74 FM outpatients. Thirty-one of the patients were not included due
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Assignment to Treatment Groups
Patients who met the inclusion criteria were randomly assigned to one of two groups. The
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assignment of the treatment procedure for the first participant was determined by a closed envelope that included a letter. Two letters indicated the different treatment approaches: PE and CTM. The first participant chose a letter that assigned her to one of these treatments and included instructions for one of the treatment procedures and the name of the treatment provider.
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For the first selection, the fourth researcher did not know which treatment was selected by the participant and asked the participant to tell her to which therapy group she had been assigned.
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After this, women who met the entry criteria were randomly assigned in a 1:1 ratio to one of the
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two treatment groups, PE or CTM, by the fourth researcher, who took a random envelope from the box with sealed envelopes. These women were also given a letter; but this time the fourth researcher had knowledge about the content of the letters.
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to meeting the exclusion criteria (Figure 1).
Twenty-one FM patients were
assigned the PE program, and 22 were assigned to receive CTM. PE was organized by the first researcher, and CTM was applied by second researcher. Only the third researcher who assessed the participants before and after the treatments was masked as to the treatment group assignments of each participant. Each group received the assigned treatment three times per
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week during a four-week period. Both the PE and CTM were performed by two experienced physiotherapists (PTs); each had a minimum of 16 years of clinical experience.
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Interventions
certified and experienced trainer. This treatment group consisted of 20 minutes of warm up and
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cool down (10 minutes before and 10 minutes after the exercises) and 40 minutes of PE. PE activity level was increased gradually, from 5 repetitions to 10. In the second week participants
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performed one repetition; in the third and fourth weeks, two repetitions were added to the ongoing exercises, and also new, higher-level exercises were added according to the group progress.
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CTM was applied in a sitting position, without back support. The thighs and feet were fully supported. A pillow was placed on the participant’s lap for forearm support. The backs of the
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participants were bare and straight for optimal tension of the connective tissue. For creating traction between the cutaneous tissues, the middle fingers were used bilaterally (Brattberg,
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1999). CTM was started from the lumbo-sacral area (basic section) and progressed to the lower thoracic, scapular, inter-scapular, and cervico-occipital sections, according to the vascular
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Each session time was one hour per treatment in the PE group, which was conducted by a
response of the connective tissue. CTM took 5 to 20 minutes in each session, depending on the treated area.
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Outcome Measures All participants provided demographic data and the self-report questionnaires including: the
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State-Trait Anxiety Inventory (STAI) (Spielberger, 2005), the Nottingham Health Profile (NHP)
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pressure (PP) threshold, tolerance and pain intensity were also evaluated by algometry (Fryer and
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Hodgson, 2005) and a Visual Analogue Scale (VAS) (Breivik et al., 2006). All participants were assessed with all of these instruments again at the end of the study.
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Self-evaluation of the pain intensity was obtained by VAS ratings. The VAS was used to measure each patient’s average pain for the last month (Breivik et al., 2006). An algometry (J Tech USA) with a one cm2 tip was used to determine PP threshold and
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tolerance levels from the upper trapezius muscle bilaterally, which is one of the tender points used for diagnosis of FM (Wolfe et al., 1990; Fryer and Hodgson, 2005). Patients were instructed
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to indicate when they first perceived pain (threshold) and when the pain became unbearable
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(tolerance), and then the pressure was stopped (Akbayrak et al., 2002). The STAI is a 40-item self-report assessment that differentiates between state anxiety (S-
anxiety) and trait anxiety (T-anxiety). The Turkish-validated version of the STAI was used (Oner
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(Aksu et al., 2004), and the Fibromyalgia Impact Questionnaire (FIQ) (Bennett, 2005). Pain
and Le Compete, 1983). High scores indicate high anxiety (Spielberger, 2005). The Turkish-validated version of the FIQ was also used (Sarmer et al., 2000). The FIQ is a brief 10-item self-administered instrument. In the revised version of the FIQ, item 1 is about physical functioning. For items 2 and 3, patients indicated the number of days that they felt well
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or missed work because of FM symptoms. Items 4 through 10 are 10 cm VASs marked in onecm increments on which the patient rated work difficulty, pain, fatigue, morning tiredness, stiffness, anxiety and depression (Bennett, 2005). A higher value indicates a higher impact of the
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disorder.
into six areas of health: energy (NHP-E), pain (NHP-P), emotional reactions (NHP-ER), sleep
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(NHP-S), social isolation (NHP-SI) and physical mobility (NHP-PM). All the parameters are summed to obtain the NHP total (NHP TOT) (Aksu et al., 2004). The Turkish version of the
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NHP was administered (Küçükdeveci et al., 2000).
Measurements were performed for each participant two times: at baseline and end of treatments. The participants were examined individually in a test room by the third researcher
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Data Analyses
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who was masked as to treatment assignment of each participant.
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Data were analyzed by Statistical Package for the Social Sciences (SPSS) Version of 17. The results were expressed as mean±standard deviation (SD) of each score. The Wilcoxon Rank test was used to analyze the data from baseline and at the end of treatment. The Mann-Whitney U-
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The NHP is a self-administered, subjective health status questionnaire with 38 items, divided
test was used to examine differences in outcome measures between the groups at baseline and at the end of treatment. Significant differences were found in baseline values of NHP-SI, NHP-PM, NHP TOT and pain intensity between the groups. No differences between the groups were observed for other baseline charecteristics (Table 1) and FIQ scores (Table 2). Thus, no other
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potentially confounding variables, beyond the baseline values of the measures, were identified. Analyses were needed to determine which intervention was more effective, controlling for differences between the two treatment groups in the baseline values of the four measures of
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interest. Mann-Whitney U-tests were performed for the differences between all baseline and the
intervention. In addition, analyses were undertaken to determine which intervention was more
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effective by eliminating the effects that could result from differences in baseline values of the four measure of interest. These analyses were undertaken for all parameters in this study.
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Because these variables were not normally distributed, non-parametric Quade’s rank analysis of covariance test was used for controlling the effect of baseline values for NHP-SI, NHP-PM, NHP TOT and pain intensity when examining differences between groups in the change in the values
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RESULTS
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for these measures. Level of significance was accepted at 0.05.
The average age and educational attainment of the PE participants were 37.13±6.37 and
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12.60±5.03 years; in the CTM group they were 36.86±7.73 and 12.71±5.10 years, respectively. No significant differences were observed in age, educational attainment , height, weight or body
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end of treatment values in each group to show the amount of the change associated with each
mass index (BMI) at baseline (Table 1). Also, 17 (47.2 %) of the participants were married; 12 (33.3 %) were single, and 7 (19.4 %) were divorced. Six participants could not complete
(unwillingness to continue n = 3, health problem n = 1, unknown n = 2) the Pilates exercise program. One participant dropped out from the CTM group (Figure 1), resulting in differences in
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the numbers of participants in the two groups and suggesting greater difficulty in compliance with the Pilates treatment that with the CTM. The baseline values of some subitems of the NHP (NHP-E, NHP-P, NHP-ER and NHP-S), Pain
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pressure, STAI and FIQ did not differ significantly between the intervention groups. However,
NHP-SI (p = .005), NHP-PM (p = .001), NHP-TOT (p = .03) and in the VAS (p = .009) (Table
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In unadjusted analyses, scores at the end of treatment did not differ between the treatment groups for the VAS and NHP, including energy, pain, emotional reactions, social isolation, sleep, and physical mobility sub-items, which were decreased in both groups (p>0.05). Scores of PP threshold and tolerance increased in both treatment groups, but no difference in overall PP was
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found between the groups. However, the PP threshold of the right (p = .031) and left (p = .014) trapezius were significantly elevated in the PE group compared to CTM group at the end of
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treatment. The unadjusted scores obtained from the State-anxiety and Trait-anxiety decreased in
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both groups, and the State-anxiety was significantly lessened in the PE group compared to the CTM group at the end of treatment (p = .008). Also, the unadjusted scores of the FIQ-9 were significantly decreased in the PE group compared to the CTM group (p = .019) at the end of the
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significant differences between the two treatment groups were found in the baseline values of
treatment (Table 2). We found significant differences in baseline values of NHP-SI, NHP-PM,
NHP TOT and pain intensity between the groups. These differences in baseline values between the groups could have partially accounted for the differences in changes in the scores from preto post-treatment between the groups. The differences of end of treatment values of NHP-SI,
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NHP-PM, NHP TOT and pain intensity between the groups were also analyzed by controlling the effect of pre-treatment values, because they differed between the groups, using the nonparametric Quade’s rank analysis of covariance test. According to Quade’s rank analysis of
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covariance test results, no significant differences were observed between the groups in NHP-SI
between the groups were found in end of treatment values of NHP-PM (p = .001) and NHP TOT
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(p = .034) after controlling for differences between groups in their baseline values. The mean post-treatment values were lower in PE group than in the CTM group (Table 2).
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When the baseline and end of treatment scores were compared, the unadjussted mean FIQ total score significantly decreased for both the PE group and CTM group (p = .001 and p = .001; Wilcoxon test) (Table 3). Thus, both PE and CTM led to significant and progressive
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improvements in overall symptomatology by the end of the treatment, according to the FIQ total score. Except for the FIQ-1 and FIQ-3 for the CTM group (p = .202 and p = .221, Wilcoxon
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(Table 3).
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test), the improvement was significantly greater in the sub-items of the FIQ with treatment
Consequently, we also analyzed differences between the baseline and end of treatment values of all parameters to investigate the effectivenesses of the interventions. Both the unadjusted and
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(p = .667) and pain intensity (p = .734) end of treatment values. However, significant differences
adjusted (for baseline values) mean differences between the baseline and end of treatment values
were calculated for the four outcome variables (pain intensity, NHP- social isolation, physical mobility, and total). The adjusted differences between the baseline and end of treatment values were larger in the PE group than in the CTM group for pain intensity (p = .009), right and left PP
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threshold (p = .007 and p = .002), state and trait anxiety (p = .016 and p = .011), NHP-pain (p = .027), social isolation (p = .005), physical mobility (p = .001) and total (p = .030), FIQ-9 (p =
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.002) and FIQ-10 (p = .006) (Table 4).
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The results of this study have demonstrated that PE and CTM may be used to provide
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improvements in females with FM. To date, this is the first controlled trial of which we are
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aware to compare the effectiveness of PE, a popular-active-group therapy, and CTM, a manualpassive-personalized therapy, in the treatment of FM.
We found limited numbers of randomized controlled trials of PE in the literature. Yakut et al. determined that PE had positive effects on chronic pain in osteoarthritis (Yakut et al.,2006).
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Donzelli et al. suggested the use of PE as an alternative approach to the treatment of non-specific low back pain (Donzelli et al., 2006). Mannerkorpi and Iversen emphasized that patients with
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FM may improve their aerobic capacity and physical function and diminish their tenderness if
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they exercise at a moderate intensity at least twice per week (Mannerkorpi and Iversen, 2003). Altan et al. found that PE was an effective and safe method for the people with FM (Altan et al., 2009).
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DISCUSSION
In the present study, the participants were predominantly physically inactive. Before the
PE, most of them thought that exercise created more pain, but the researchers encouraged and told them that this has not been shown in the literature. Moreover, pain and disability reduction were their goals. They were also interested in improving their posture and flexibility. At the end
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of this study, the patients in PE group changed their minds, and they had much more confidence that they could use their muscles without pain. In 1991, Goats and Keir determined that CTM increased blood flow and gave pain relief (Goats
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and Keir, 1991). McKechnie et al. showed that CTM could reduce tension and anxiety
decreasing stress hormones and muscle tension and increasing pain thresholds (Brattberg, 1999).
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CTM is thought to be an effective method that produces general body relaxation, reduces muscle spasm and connective tissue tenderness, and increases plasma β endorphins (Çıtak-Karakaya et
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al. 2006). CTM has also positive effects on autonomic responses (Çıtak-Karakaya et al. 2006; Goats and Keir, 1991). Brattberg found that as long as effective medical treatment is lacking for individuals with FM, treatment with CTM should be offered (Brattberg, 1999). CTM and
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combined ultrasound therapy has also been helpful in improving pain intensity, complaints of nonrestorative sleep, and functional activities in patients with FM (Çıtak-Karakaya et al. 2006).
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Chronic pain in FM can cause prevalent and important psychological problems, such as
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anxiety. Anxiety is an emotion that influences the perception of pain, as it tends to lower both PP threshold and tolerance (Williams, 2003; Goats and Keir, 1991). It is an emotional disorder frequently encountered in women with FM. Coexistent anxiety is a significant predictor of
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(McKechnie et al., 1983). In addition, touching the skin in itself has positive effects by
functional impairment in FM patients (Amital et al., 2006). Also, chronic pain is the most frequent cause of disability and seriously affects the HRQoL of millions of human beings. Actually, a close relation has been shown among pain, psychosocial health and health-related quality of life (HRQoL) (Ekici and Akbayrak, 2007). Consequently, while planning treatment
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programs, these relationships must be taken into account. In this study, pain intensity and the symptoms of anxiety were decreased, and HRQoL was supported in both groups. The reduction in State-anxiety and Trait-anxiety reactions were also significant in our
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results, confirming the association of both variables (Pain and anxiety), which were noted in this
anxiety in both groups; however, the PE group showed much more effectiveness in reducing
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anxiety compared to CTM. The results of this study identified that mental and physical relaxation, isolation of each part of each exercise, visual imagination and breathing controls in
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PE had positive effects on emotional relief as a mind-body therapy (Yakut et al., 2006). Also, after controlling for the significant differences in baseline values between the groups, the physical mobility and HRQoL level were found to be more improved in the PE group than CTM
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group. Additionally, the originality and variety of the exercises may have encouraged a more proactive and trusting attitude toward the program (Donzelli et al., 2006). The originality of the
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Pilates method stimulated the patients’ interest in this technique. However, these are only subjective observations that need further investigation and confirmation in larger randomized
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controlled trials.
A majority of FM patients report pain and stiffness in the neck-shoulder muscles, and a
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type of patients (Spielberger, 2005). In this study, significant improvements were found in
majority develop FM from localized or regional muscle pain conditions, such as trapezius myalgia (Sandberg et al., 2005). Our clinical experience also indicated that the trigger points of the trapezius were highly painful in FM patients. This is why the trapezius was chosen for
assessing the PP threshold and tolerance in the current study. The scores for PP threshold and
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tolerance were increased in both groups at the end of the treatment. Nevertheless, the PP threshold level in the PE group was higher than CTM group after treatment. PE and CTM support HRQoL according to the NHP, in terms of feelings of social
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isolation, physical mobility, energy level, sleep disturbances and emotional reaction in this
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FIQ in both treatment groups.
The results of this study confirmed previous published studies (Çıtak-Karakaya et al.
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2006; Brattberg, 1999) for the efficacy of CTM in treating FM as indicated by a reduction in the VAS, NHP and FIQ. Similarly, good results were obtained with PE; however, PE was more efficacious than CTM in terms of the PP threshold and anxiety.
A possible explanation is that Pilates is composed of active, simple and easily adaptable
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exercises; however, CTM is a personalized and passive treatment approach. Also, a major
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difference between interventions was the use of the group setting for Pilates; thus, the treatment effect could also be from the group interaction or both the interaction and the treatment. It was
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not possible to separate the effects of treatment from those of the group interaction in the current study design.
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current work. Improvements were also found in multiple dimensions of progress based on the
In conclusion, these results suggest that PE and CTM may be of benefit in the treatment of FM and may also have some wider benefits in terms of HRQoL. These results are encouraging. However, PE had more effectiveness on anxiety symptoms and PP threshold than CTM in the current pilot study. The study did have some limitations worth noting in interpreting the results.
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First, because the sample size was small, inadequate statistical power resulted, making it difficult to explain which approach was more beneficial for FM because we had insufficient statistical power to detect some meaningful differences as statistically significant. In the group therapies,
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more patients can benefit from the treatment at the same time. Also, exercise should become a
preferred by the PTs. However, the second main limitation of the study was the unwillingness of
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patients to continue in the groups, especially for PE, making the acceptability and applicability of these methods questionable. A third limitation was that although many active and passive
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therapy techniques could be used for FM, as an active intervention PE and as a passive intervention CTM were selected in this study; this, combined with the sample being restricted to one study site, results in the generalizability of results being limited. Additionally, participants were unequally distributed between the groups due to lower compliance and completion in the
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PE group (in PE group n = 15, in CTM group n = 21). Also, the study did not include long-term follow-up to assess for the durability of effects. Further, because this study included only
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women, these results cannot be extended to men with FM.These results indicated that different
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approaches can be used for treatment of FM. Furthermore, harmonizing the approaches according to the patients’ needs may be the best for obtaining the optimal outcome. Despite the theoretical basis and observational positive results, future research with larger sample sizes and
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part of the treatment plan for people with FM. Because PE has some advantages, it may be
using a randomized controlled design is required to determine the effectiveness of PE and CTM as therapeutic interventions. The current pilot study may highlight preliminary results for further studies on this subject. Also, further studies should be carried out larger number of groups, male patients and long-term follow-up results.
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t
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related syndromes. Best Pract Res Clin Rheumatol 17(4): 649-665.
22
CTM Group (n = 21)
z
Age (years)
37.13±6.37
36.86±7.73
-0.225
Height (meter)
1.61±0.05
1.63±0.07
(kilogram)
Body
Mass
Index
.822
cr ip
60.00±3.48
-0.805
60.00±8.85
23.23±2.25
ce
pt
PE: Pilates Exercises, CTM: Connective Tissue Massage.
23
.421
.573 -0.564
22.48±3.12
ed
(kg/m²)
us
Weight
M an
Body
p
t
PE group (n = 15)
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Table 1. Baseline characteristics of the sample (mean ± SD).
.619 -0.497
Table 2. Comparison of the Nottingham Health Profile, Pain Intensity, Pain Pressure, State-Trait Anxiety Inventory, and Fibromyalgia Impact Questionnaire scores of PE and CTM groups at baseline and at the end of treatment (mean±SD) CTM
baseline
z and p
PE group
CTM
z and p
value for
end of
group end
values for
differences
treatment
baseline between (n = 15)
value
of
differences
treatment
between
(n=15)
us
groups at
groups at
(n=21)
(n = 21)
ce
Energy
56.59±24.5
52.99±29.75
7
Pain
z
p
-
.566
treatment
Mean± SD Mean± SD
z
p
3.36±30.4
27.58±34.
-
.890
3
80
0.13
pt
Health Profile
Mean±SD
end of
ed
Nottingham
baseline
M an
Mean± SD
0.57
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value
cr ip
group
t
PE group
66.92±12.2
4
56.35±28.44
8
-
.268
1.10
24
12.21±11.
18.10±14.
1.12
.263
1
8
Emotional
46.60±24.9
reactions
9
38.24±32.81
-
.335
96
37
0
8.73±9.22
13.10±16.
-
41
0.19
t
0.96
Isolation
2
-
.005
2.84
*
Sleep
37.44±30.9
Total
20.14±15.47
3
ce
Mobility
43.39±22.5
pt
Physical
28.24±27.49
-
3.98±10.4
4
.361
6.95±8.01
8
5.22±8.80
.667
0.18 8ª
-
0.91
0.98
3
1
ed
2
9.11±10.2
M an
0
cr ip
16.76±25.99
9
us
43.32±31.1
-
.001
3.28
*
8.67±6.00
12.80±12. 23
.326
.001 17.7
*
4ª
1
294.25±90.
212.73±124.
-
.030
69.03±38.
80.79±64.
.034
21
50
2.16
*
34
73
*
Ac
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4
Social
.842
6
4.85ª
25
8.75±0.91
Pain
6.62±2.45
.009
intensity (0-
0.11
0
7ª
cr ip us
pressure
1.43±0.30
Tolerance
(right side)
1.64±0.55
pt
1.53±0.34
ce
(left side)
1.51±0.46
-
-
.031
0.32
2.15
*
5
8
ed
(right side)
M an
(kg/cm2)
5.09±0.77
Ac
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*
Pain
Threshold
.734
2.62
10cm)
Threshold
2.53±2.16
t
(VAS)
-
2.15±0.90
5.17±1.41
.745
-
.617
2.75±0.52
-
.014
0.50
2.46
*
0
0
-
.772
3.03±0.61
2.30±0.76
6.13±1.26
2.47±0.90
6.23±1.28
1.00
0.28
0.00
9
0
26
0
Tolerance
4.47±0.65
5.16±1.62
.563
5.71±1.00
6.38±1.41
-
0.57
1.47
9
7
.140
cr ip
t
(left side)
-
Anxiety
47.73±10.6
Anxiety
7
48.33±12.56
-
.846
32.33±7.2
41.81±12.
-
.008
5
50
2.66
*
M an
State-
us
Inventory
0.19 5
55.07±6.43
50.71±10.63
ed
Trait-
.209
1.25 5
Fibromyalg ia
4
45.33±7.9
46.05±7.5
-
5
5
0.25 8
ce
pt
Anxiety
-
Impact
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State-Trait
Questionnai re
27
.796
1 Physical
2.54±1.96
2.47±1.84
.796
1.06±0.99
2.05±1.59
-
0.25
1.92
9
6
.054
4.58±3.07
4.56±2.74
good
-
.947
0.06
Work
1.62±1.78
missed
Work
6.53±2.36
6.05±2.98
ce
pt
impairment
5 Pain
6 Fatigue
-
6.80±2.65
6.38±2.67
7.80±1.56
6.57±2.93
-
.101
0.48±1.03
0.36±1.12
0.71
8
3
-
.662
2.10±1.78
2.64±2.34
-
0.43
0.58
7
3
-
.627
2.43±1.21
3.38±2.22
-
0.48
1.13
6
2
-
.324
0.98
28
.159
0
1.63
ed
4
0.79±1.64
3.06±1.99
1.41
M an
3
2.19±1.31
us
6
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2 Days felt
cr ip
t
impairment
-
4.17±1.72
4.12±2.58
0.42
.476
.560
.258
.674
7
5.77±3.23
6.45±2.98
tiredness
-
.488
2.83±1.23
0.69
.266
7.40±2.23
6.26±2.76
-
6.37±2.42
ce
Depression
Total
5.14±3.23
pt
10
55.12±10.0 7
50.20±22.46
3.69±2.85
.244
0.84 0
1.16
2.34
*
4
9
.295
1.23±0.73
3.88±2.93
.401
.019
-
1.63±0.79
-
-
ed
9 Anxiety
4.17±1.77
M an
3
cr ip
-
us
5.71±3.36
.064
1
1.11
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7.27±1.62
1.85
4
8 Stiffness
4.67±2.73
t
7 Morning
0
2.98±2.50
-
1.04
1.69
8
9
0.22 9
.229
22.12±4.5
28.68±14.
0.20
8
22
5
*p < .05. PE: Pilates Exercises, CTM: Connective Tissue Massage.
29
.089
.205
Possible range of Nottingham Health Profile and subgroup scores: Energy: 0-100, Pain: 0-100, Emotional reactions: 0-100, Social Isolation: 0-100, Sleep: 0-100, Physical Mobility: 0-100, Total: 0-600.
t cr ip
Possible range of State-Trait Anxiety Inventory scores: State-Anxiety: 20-80, Trait-Anxiety: 20-
us
80.
Possible range of Fibromyalgia Impact Questionnaire (FIQ) and subgroup scores: 1 Physical
M an
impairment; 2 Days felt good; 3 Work missed; 4 Work impairment; 5 Pain; 6 Fatigue; 7 Morning tiredness; 8 Stiffness; 9 Anxiety; 10 Depression: 0-10 (each one). Total: 0-100. ª : Quade’s rank analysis of covariance test was used, to control for the significant difference
ce
pt
ed
observed between groups in the baseline values.
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Possible range of pain intensity: 0-10 cm.
30
Table 3. Comparison of the baseline and end of treatment scores of the Nottingham Health Profile, Pain Intensity, Pain Pressure, State-Trait Anxiety Inventory, and Fibromyalgia Impact
z and p
baseline
end of
value for
CTM
CTM
t
PE group
z and p
cr ip
PE group
group end
value for
of
differences
group value
treatment
differences between
us
baseline
treatment
between
value
and end of
treatment
treatment
z
p
Mean±SD
Mean± SD
z
p
52.99±29.75
27.58±34.
-
.003
80
2.98
*
ce
Profile
and end of
pt
Nottingham Health
Mean± SD
baseline
ed
Mean± SD
M an
baseline
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Questionnaire (mean±SD)
Energy
56.59±24.5
23.36±30.
-
.003
7
43
2.94
*
7
8
31
Pain
66.92±12.2
12.21±11.
-
.001
1
96
3.40
*
56.35±28.44
18.10±14.
-
.001
37
4.01
*
5
reactions
9
8.73±9.22
-
.001
3.18
*
0
43.32±31.1
9.11±10.2
-
.001
2
4
3.18
*
Isolation
38.24±32.81
16.76±25.99
M an
Social
cr ip
46.60±24.9
13.10±16.
-
.002
41
3.12
*
us
Emotional
37.44±30.9
ce
pt
2
6.95±8.01
Physical
43.39±22.5
Mobility
3
Total
-
.003
2.93
*
ed
Sleep
8.67±6.00
294.25±90.
28.24±27.49
-
.037
8
2.08
*
1
5.22±8.80
4
-
.001
3.29
*
-
-
.001
3.18
*
7
20.14±15.47
12.80±12.
-
.004
23
2.85
*
6
69.03±38.
5
3.98±10.4
4
Ac
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t
8
2
.001
3.40
212.73±124.
80.79±64.
4.01
32
.001
Pain
21
34
8.75±0.91
2.15±0.90
50
73
.001
6.62±2.45
2.53±2.16 -
t 5
1.43±0.30
2.75±0.52
-
.001
3.41
*
1.51±0.46
2.30±0.76
ed
(right side)
M an
(kg/cm2)
pt
5
1.53±0.34
3.03±0.61
ce
(left side)
Tolerance
(right side)
*
cr ip
1
pressure
Threshold
.001
4.01
Pain
Threshold
*
us
10cm)
5
*
3.41
(0-
Ac
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*
-
intensity (VAS)
8
5.09±0.77
.001
4.02
*
1
-
.001
3.41
*
1.64±0.55
2.47±0.90
3
6.13±1.26
-
-
.001
4.02
*
0
-
.001
3.40
*
9
5.17±1.41
6.23±1.28
-
.001
3.92
*
3
33
Tolerance
4.47±0.65
5.71±1.00
(left side)
-
.001
3.41
*
5.16±1.62
6.38±1.41
.001
3.89
*
6
Anxiety Inventory
47.73±10.6
32.33±7.2
-
.001
7
5
3.41
*
Anxiety
48.33±12.56
M an
State-
41.81±12.
-
.002
50
3.04
*
0
55.07±6.43
45.33±7.9
-
.001
5
3.30
*
ed
Trait-
5
Fibromyalg ia
50.71±10.63
5
46.05±7.5
-
.001
5
3.38
*
8
ce
pt
Anxiety
Impact
Ac
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State-Trait
us
cr ip
t
2
-
Questionnai re
34
1
Physical
2.54±1.96
1.06±0.99
impairment
-
.005
2.81
*
2.47±1.84
2.05±1.59
-
.221
1.22 4
2.19±1.31
good
-
.011
2.55
*
5
Work
1.62±1.78
missed
0.48±1.03
-
.010
2.58
*
0.79±1.64
M an
3
4.56±2.74
3.06±1.99
us
4.58±3.07
0.36±1.12
Work
6.53±2.36
2.10±1.78
ce
pt
impairment
5 Pain
6 Fatigue
-
.001
3.23
*
ed
4
6.80±2.65
2.43±1.21
7.80±1.56
6.05±2.98
2.64±2.34
9
2.22
*
0
-
.202
-
.001
3.66
*
9
-
.001
3.18
*
-
.026
6
6.38±2.67
3.38±2.22
4
4.17±1.72
-
1.27
5
Ac
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2 Days felt
cr ip
t
0
-
.001
3.23
*
9
.001
3.19
6.57±2.93
4.12±2.58
2.87
35
.004
tiredness
-
.005
2.81
*
7.27±1.62
4.17±1.77
-
.001
3.30
*
7.40±2.23
5.71±3.36
M an
9 Anxiety
1.63±0.79
4.67±2.73
-
.001
3.41
*
3.69±2.85
6.26±2.76
3.88±2.93
ed
1
6.37±2.42
ce
Depression
Total
1.23±0.73
pt
10
-
.007
2.70
*
6
9
-
.001
3.41
*
5.14±3.23
-
.013
2.48
*
9
-
.008
2.63
*
8
2.98±2.50
0
-
.007
2.68
*
2
55.12±10.0
22.12±4.5
-
.001
7
8
3.40
*
Ac
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8
8 Stiffness
6.45±2.98
*
t
2.83±1.23
9
cr ip
5.77±3.23
*
us
7 Morning
3
50.20±22.46
8
28.68±14.
-
.001
22
3.38
*
9
* p
