Accepted Manuscript The short-term effects of graded activity versus physiotherapy in patients with chronic low back pain: a randomized controlled trial Mauricio Oliveira Magalhães, Luzilauri Harumi Muzi, Josielli Comachio, Thomaz Nogueira Burke, Fabio Jorge Renovato França, Luiz Armando Vidal Ramos, Gabriel Peixoto Almeida Leão, Ana Paula de Moura Campos Carvalho-e-Silva, Amélia Pasqual Marques PII:
S1356-689X(15)00021-1
DOI:
10.1016/j.math.2015.02.004
Reference:
YMATH 1682
To appear in:
Manual Therapy
Received Date: 6 August 2014 Revised Date:
6 February 2015
Accepted Date: 13 February 2015
Please cite this article as: Magalhães MO, Muzi LH, Comachio J, Burke TN, Renovato França FJ, Vidal Ramos LA, Almeida Leão GP, de Moura Campos Carvalho-e-Silva AP, Marques AP, The short-term effects of graded activity versus physiotherapy in patients with chronic low back pain: a randomized controlled trial, Manual Therapy (2015), doi: 10.1016/j.math.2015.02.004. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
ACCEPTED MANUSCRIPT
The short-term effects of graded activity versus physiotherapy in patients with chronic low back pain: a randomized controlled trial
Mauricio Oliveira Magalhães¹, Luzilauri Harumi Muzi¹, Josielli Comachio¹, Thomaz
RI PT
Nogueira Burke¹,³, Fabio Jorge Renovato França¹, Luiz Armando Vidal Ramos¹,4, Gabriel Peixoto Almeida Leão¹,², Ana Paula de Moura Campos Carvalho-e-Silva¹,
1
M AN U
SC
Amélia Pasqual Marques¹
Physical Therapy, Speech and Occupational Therapy Department, School of Medicine,
University of São Paulo, São Paulo, Brazil.
TE D
² Physical Therapy Division, School of Medicine, Federal University of Ceará, Ceará, Brazil.
³Bioscience Division, Federal University of São Paulo, São Paulo, Brazil University Federal do Amapá - Campus Binacional do Oiapoque, Amapá, Brazil.
EP
4
AC C
Corresponding author:
Mauricio Oliveira Magalhães Rua Cipotânea 51, Cidade Universitária Postal Code: 05360-160 São Paulo, SP, Brazil. E-mail: [email protected]
ACCEPTED MANUSCRIPT Abstract Background: Chronic low back pain is one of the most common problematic health conditions worldwide and is highly associated with disability, quality of life, emotional
RI PT
changes, and work absenteeism. Graded activity programs, based on cognitive behavioral therapy, and exercises are common treatments for patients with low back pain. However, recent evidence has shown that there is no evidence to support graded activity for patients with chronic nonspecific low back pain. Aim: to compare the
SC
effectiveness of graded activity and physiotherapy in patients with chronic nonspecific
M AN U
low back pain. Methods: A total of 66 patients with chronic nonspecific low back pain were randomized to perform either graded activity (moderate intensity treadmill walking, brief education and strength exercises) or physiotherapy (strengthening, stretching and motor control). These patients received individual sessions twice a week for six weeks. The primary measures were intensity of pain (Pain Numerical Rating
TE D
Scale) and disability (Rolland Morris Disability Questionnaire). Results: After six weeks, significant improvements have been observed in all outcome measures of both
EP
groups, with a non-significant difference between the groups. For intensity of pain (mean difference = 0.1 points, 95% confidence interval [CI] = -1.1 to 1.3) and disability
AC C
(mean difference = 0.8 points, 95% confidence interval [CI] = -2.6 to 4.2). No differences were found in the remaining outcomes. Conclusion: The results of this study suggest that graded activity and physiotherapy showed to be effective and have similar effects for patients with chronic nonspecific low back pain.
ACCEPTED MANUSCRIPT
1. INTRODUCTION Chronic nonspecific low back pain is one of the most common problematic
RI PT
health conditions worldwide and is highly associated with disability, poor quality of life, emotional changes, and work absenteeism (Airaksinen et al. , 2006, Delitto et al. , 2012). Chronic nonspecific low back pain accounts for 95% of cases of low back pain
SC
and is characterized by a defined etiology and the presence of symptoms for at least 12 weeks (Airaksinen, Brox, 2006). A recent systematic review reports that 39% of adults
M AN U
will experience at least one episode of back pain during their lifetime (Hoy et al. , 2012). The annual direct costs of chronic nonspecific low back pain in the United States range from $12.2 to $90.6 billion dollars, which represents only 14.5% of the total costs (Dagenais et al. , 2008). In Brazil, as the second most frequent health complaint, it is
al. , 2011).
TE D
estimated that 13.5% of the population suffers from chronic back problems (Barros et
In an attempt to reduce the impact associated with chronic nonspecific low back
EP
pain, certain treatments have been recommended by The European Guidelines for the Management of Chronic Low Back Pain as effective in the treatment of the condition,
AC C
such as manipulation/mobilization, acupuncture, back school, and multidisciplinary treatment (Airaksinen, Brox, 2006). Moreover, studies show that exercise therapy associated with education can been effective in reducing low back pain and disability (van der Roer et al. , 2008, van Middelkoop et al. , 2011). Among the methods used in exercise therapy are exercise and cognitive behavioral therapy (Airaksinen, Brox, 2006). Exercise programs may include the following kinds of exercise: aerobic, stretching, balance, motor control, coordination, and strengthening specific (e.g., the
ACCEPTED MANUSCRIPT transversus, abdominis, or multifidus) or global (e.g., the trunk, abdomen, or back) muscles (van Middelkoop et al. , 2010). Among these exercises, the practice of strengthening exercises, stretching, and motor control have shown good efficacy in reducing pain and disability in patients with chronic nonspecific low back pain
RI PT
(Airaksinen, Brox, 2006, Dufour et al. , 2010, Smith and Grimmer-Somers, 2010). A recent systematic review (Macedo et al. , 2009) shows that lumbar stabilization exercises are more effective than minimal intervention (booklet), yet the two have
SC
similar effects when compared to manual therapy or other types of exercises. A systematic review written by Macedo et al. (Macedo, Maher, 2009) recommends motor
M AN U
control exercises in conjunction with other types of exercise.
The cognitive behavioral therapy approach to low back pain uses interventions and counseling strategies to help change attitudes and inadequate beliefs that may negatively influence symptoms (Lamb et al. , 2010, Rundell and Davenport, 2010). The
TE D
cognitive behavioral model of treatment assumes that disability is determined not only by the underlying pathology, but also by social, cognitive, emotional, and behavioral factors. The graded activity program, based on the cognitive behavioral therapy, was
EP
developed based on studies suggesting that cognitive-behavioral aspects and operant conditioning principles can be used to reinforce healthy behaviors (Macedo et al. ,
AC C
2012). Moreover, the program was based on activities that each participant identified as problematic and that he or she could not perform or had difficulty performing because of back pain (Macedo, Latimer, 2012). The program focuses on functional activities and progress in a time-contingent manner regardless of pain to achieve functional goals and increased activity. Quotas, pacing, and self-reinforcement are key features of the program (Macedo, Latimer, 2012, Macedo et al. , 2010). Graded activity aims to reduce pain and disability by addressing pain-related fear, kinesiophobia, and unhelpful beliefs
ACCEPTED MANUSCRIPT and behaviors about back pain while correcting physical impairments such as reduced endurance, muscle strength, and balance (Leeuw et al. , 2008). A systematic review suggests that graded activity in the short-term and intermediate-term is slightly more effective than minimal intervention (i.e., usual care,
RI PT
waiting list, sham exercise, advice to stay active, or care by a general practitioner), yet is no more effective than other forms of exercise for persistent chronic nonspecific low back pain (Macedo, Smeets, 2010). However, among trials that compared graded
SC
activity with other forms of exercise, two treated patients with sub-acute low back pain (Anema et al. , 2007, Heymans et al. , 2006), two others had poor methodological
M AN U
quality (Critchley et al. , 2007, Nicholas et al. , 1991), and one trial conducted only one treatment session per week, which is questionable in terms of the optimal way to implement an intervention (Nicholas et al. , 1992). Although some studies show that graded activity are effective in reduce pain and disability in patients with chronic
TE D
nonspecific low back pain (Macedo, Latimer, 2012, van der Roer, van Tulder, 2008), recent systematic review has shown that, currently, there is insufficient evidence that graded activity is better for these outcomes in patients with non-specific LBP (van der
EP
Giessen et al. , 2012). Therefrom, more studies are necessary to evaluate the benefits are graded activity in patients with chronic nonspecific low back pain.
AC C
Therefore, the purpose of this study was to compare the effectiveness of graded
activity and physiotherapy in patients with chronic nonspecific low back pain.
2. Methods
2.1 Study Design This randomized controlled trial (RCT) recruited patients with chronic nonspecific low back pain. Patients were randomized into either Graded Activity (GA) Group or Physiotherapy Exercise (PE) Group. This study was approved by the ethics committee
ACCEPTED MANUSCRIPT of the School of Medicine of the University of Sao Paulo (Protocol 393/12), and was registered at clinicaltrials.gov (registration number: NCT01719276). All participants gave their informed consent before participation. 2.2 – Participants
RI PT
Sixty-six patients with chronic nonspecific low back pain diagnosed by an orthopedist were recruited from Specialized Rehabilitation Services at Taboão da Serra in Sao Paulo, Brazil. The inclusion criteria were as follows: chronic nonspecific low
SC
back pain, age between 18 and 65 years, and a minimum pain intensity score of three in the 11-point Pain Numerical Rating Scale (Costa et al. , 2008). Participants were
M AN U
excluded if they had any of the following criteria: known or suspected serious spinal pathology (e.g., fractures, tumors, inflammatory, rheumatologic disorders, or infective diseases of the spine), nerve root compromise, scheduled surgery, comorbid health conditions that would prevent active participation in the exercise programs, pregnancy,
TE D
or cardio-respiratory illnesses.
In order to ensure the patients’ safe participation in the study, the Physical Activity Readiness Questionnaire (PAR-Q) (Shephard, 1988) was used. Those
EP
answering “yes” to any of the questionnaire’s questions were excluded from the study.
AC C
2.3 – Randomization and blinding Simple randomization was conducted using Microsoft Excel for Windows software
(Microsoft Corporation, Redmond, Washington) by a researcher who was not involved in the recruitment of the participants. The allocation sequence was generated by one of the study’s authors, who was not involved with participant recruitment or treatment. The allocation was concealed by using consecutively numbered, sealed, opaque envelopes. After the baseline assessment, eligible participants were referred to the
ACCEPTED MANUSCRIPT physical therapist overseeing the treatment, who conducted their randomized allocation to the different treatments. The assessor was blind to the treatment allocation. Given the nature of the interventions, it was not possible for the therapist or the patients to be
RI PT
blinded.
2.4 - Sample size
The study’s sample size was designed in order to detect a two-point minimum
SC
difference between groups in terms of pain intensity outcome measured on the Pain Numerical Rating Scale, assuming a standard deviation of 1.9 points (Costa, Maher,
M AN U
2008). The study also sought to detect a 4-point difference in functional disability measured on the Roland Morris Disability Questionnaire, with an estimated standard deviation of 4.9 points (Costa, Maher, 2008, Costa et al. , 2007). Power was defined as 80% for an alpha of 5% and attrition (drop-outs) of 15%. The required sample was set at
2.5 - Assessment
TE D
33 patients per group.
EP
All measurements were conducted by a physical therapist blinded to the patient groups. A physiotherapist, who was unaware of the treatment allocation, screened
AC C
people in order to confirm eligibility criteria, as well as obtained demographic and anthropometric data. The investigator also assessed primary (pain intensity and disability) and secondary (quality of pain, quality of life, global perceived effect, return to work, physical activity, physical capacity, and kinesiophobia) outcomes. The Brazilian-Portuguese versions of the scales and questionnaires used in the study presented adequate psychometrical properties (Ciconelli et al. , 1999, Costa, Maher,
ACCEPTED MANUSCRIPT 2008, Florindo and Latore, 2003, Menezes Costa Lda et al. , 2011, Nusbaum et al. , 2001).
2.5.1 - Primary outcomes
RI PT
Pain
The Pain Numerical Rating Scale (NRS) is an 11-point scale ranging from 0 to 10, where 0 represents the absence of pain, and 10 represents unbearable pain (Costa,
SC
Maher, 2008). Participants were asked to focus assessment on their average pain levels
M AN U
over the week before assessment (Costa, Maher, 2008).
Disability
The Roland Morris Disability Questionnaire is a 24-item questionnaire dealing with normal activities of daily living. Participants were asked to tick the items that they
TE D
perceived as difficult to perform due to low back pain. Each answer is scaled either “no” (difficulty = 0 points) or “yes” (difficulty = 1 point), thus leaving a range of scores from 0 to 24, with a higher score indicating a higher level of disability (Costa, Maher, 2008,
EP
Costa, Maher, 2007, Nusbaum, Natour, 2001).
AC C
2.5.2 - Secondary Outcomes Quality of pain
The McGill Pain Questionnaire allows for a multidimensional assessment of pain. It consists of 78 descriptors assigned with intensity values that are grouped
into four major domains (sensory, affective, evaluative, and miscellaneous) and 20 subdomains, each with two to six descriptors. The questionnaire is used to describe pain experience and provides a total score that corresponds to the sum
ACCEPTED MANUSCRIPT of the values from each chosen descriptor. Maximal scores are as follows: sensorial = 41, affective = 14, evaluative = 5, miscellaneous = 17, total = 77 (Varoli and Pedrazzi, 2006).
RI PT
Quality of life
Health-related qualify of life (HRQoL) was assessed using the Short-Form Health Survey Questionnaire (SF-36), which consists of 36 questions grouped into eight
SC
domains: vitality (four items), physical functioning (ten items), bodily pain (two items), general health perception (five items), physical role functioning (two items), emotional
M AN U
role functioning (three items), social role functioning (two items), and mental health (five items). For each section, scores range from 0 to 100, with higher scores reflecting a better quality of life. The study focused on physical and emotional role functioning
TE D
(Ciconelli, Feraz, 1999).
Global Perceived Effect
Self-perception of treatment-associated improvement was measured with the
EP
global perceived effect scale. This 11-point numerical scale compares symptoms upon treatment’s end with those at pre-treatment. The scale ranges from -5 to +5, with
AC C
negative values reflecting a worsening of symptoms (-5 being the most significant in this sense), and positive values reflecting improvement (+5 reflecting total recovery) (Costa, Maher, 2008).
Return to Work
ACCEPTED MANUSCRIPT At post-treatment assessments, participants were asked if they were working. If the participants answered “no” to this question, they were further questioned if they were not working due to low back pain.
RI PT
Kinesophobia
The Tampa Scale of Kinesophobia (TSK) is a self-applied questionnaire consisting of 17 items that was developed to measure fear of movement due to chronic
SC
low back pain. Each question has four response options: totally disagree (1 point), partially disagree (2 points), partially agree (3 points), and totally agree (4 points). The
M AN U
scores of questions 4, 8, 12, and 16 were obtained through an inversion of the response values. The total score of the questionnaire corresponds to the sum of the scores of all questions and ranges from 17 to 68 points (de Souza et al. , 2008, Siqueira et al. , 2007).
TE D
Daily Physical Activity
The Baecke Questionnaire of Habitual Physical Activity measures physical activity in three domains: occupational activity, physical exercises, and leisure and
EP
locomotion. It consists of 16 questions structured using a quantitative Likert scale. The score is calculated by the sum of the domain scores. Physical activity is stratified as
AC C
mild (3.0-6.7), moderate (6.8-8.1) and intense (8.2-15.0) (Florindo and Latore, 2003).
Physical capacity
Sit-to-stand and 15.2m walking test was performed. Five repetitions of the sit-tostand test were used at maximal speed without use of the hands (Ocarino et al. , 2009). After five minutes, the walking test was performed. Patients walked 7.62m around two obstacles and returning to their initial position. Patients repeated the walking test after
ACCEPTED MANUSCRIPT an interval of three minutes, and the average value was used for analysis (Ocarino, Gonçalves, 2009). Time was measured using a digital manual stopwatch (instrutherm®).
RI PT
2.6 - Intervention
The intervention lasted six weeks, twice a week, totaling 12 hourly sessions. The Physiotherapy Exercise Group performed under the supervision of the researcher, and
SC
the participants were instructed to report any complaint related to the exercise. In addition, participants were instructed not to participate in any other intervention during
M AN U
the treatment period. There was no interference in the use of medication. The protocol for this study has been published previously (Magalhaes et al. , 2013).
2.6.1 – Physiotherapy Exercise Group
TE D
The protocol for the Physiotherapy Exercise Group was based on a protocol reported by França et al. (Franca et al. , 2012, Franca et al. , 2010) comprised of stretching (e.g., exercises focusing on the erector spinae, hamstrings, and triceps surae),
EP
strengthening (e.g., exercises focusing on the rectus abdominis, abdominus obliquus internus, and abdominus obliquus externus), and motor control exercises (e.g., exercises
AC C
focusing on the TrA and lumbar multifidus muscles). Moreover, Physiotherapy Exercise Group did not include interventions such as manual therapy.
2.6.2 - Graded Activity Group The Graded Activity Group followed protocols described by Macedo et al. (Macedo et al. , 2008) and Smeets et al. (Smeets et al. , 2006), both of which are founded on individual sessions of progressive and sub-maximal exercises that aim to
ACCEPTED MANUSCRIPT improve physical fitness and stimulate changes in behavior and attitude. The protocol of this group consisted of aerobic training on a treadmill and lower limb and trunk strengthening exercises. In the beginning of the treatment, patients selected one or two activities they considered difficult for them and received guidance on these throughout
RI PT
the treatment. Participants also received an educational booklet (based on the “Back Book”(Roland et al. , 1996) with important information on how to care for the spine. To determine the load of strengthening exercises, the 10-repetition maximum test was used
SC
(Navega et al. , 2006). During the first two weeks of training, individuals exercised using 50% of their maximum load. On the third and fourth week, the loads were made
M AN U
to be 60% maximum, and during the final two weeks, they were made to be 70% maximum. Heart rate (HR) was calculated using the formula of Karvonen (HRmax = 200 – age) for sedentary individuals: Exercise HR = Resting HR + 70% to 80% of maximum HR (McARDLE, 1997).
TE D
2.7 - Statistical Analysis
Data normality was assessed using the Kolmogorov–Smirnov test. A student ttest was used to test differences between groups at the baseline, and a two-way ANOVA
EP
(Group x Time) followed by Tukey’s post-hoc test were used for normal data after intervention. For non-normal data, the Wilcoxon signed-rank test was used. All
AC C
statistical tests were performed with the software SigmaStat 3.5 (Systat Software, Inc., Germany) and MS Excel Office 2007. The confidence interval was established at 95%, and the significant level at 5%. The relative gain with treatment was calculated using the following equation: RGi = (Baselinei − Endi) x 100 Baselinei
ACCEPTED MANUSCRIPT 3. Results Ninety-five subjects with chronic nonspecific low back pain were assessed for eligibility. Of these, 29 were excluded (Figure 1). Following this, 66 patients were assessed at baseline and randomly allocated into one of two groups (Physiotherapy
RI PT
Exercise Group = 33, or Graded Activity Group = 33). Post-analysis treatment was
SC
performed on 66 patients.
M AN U
Assessed for eligibility (n=95)
TE D
Enrollment
15 More than 65 years old 3 Nerve root compromise 3 Pregnancy 2 Pain intensity score < 3 4 Rheumatologic disorders 2 Scheduled Surgery
AC C
EP
Baseline assessement (n=66)
Randomized (n=66)
Allocation
Physiotherapy Exercise Group (n=33)
Graded Activity Group (n=33)
Discontinued Intervention
Discontinued Intervention
(N = 3)
(N = 3)
Analysis (n=30)
Analysis (n=30) Analysis
ACCEPTED MANUSCRIPT
Figure 1: Participant flow diagram
RI PT
The Physiotherapy Exercise Group consisted of 25 women and 8 men, with a mean age of 46.6 (9.5) years, while the graded activity group consisted of 24 women and 9 men, with a mean age of 47.2 (10.5) years. Table 1 shows the clinical and
SC
demographic characteristics of the participants. Participants allocated into the Graded Activity Group presented a greater duration of symptoms compared to the participants
M AN U
of the Physiotherapy Exercise Group. The main drugs used by the participants in both groups for symptom control were analgesics and anti-inflammatories (PE Group = 10 [55%], and GA Group = 9 [64%]). Furthermore, among the participants who had undergone previous physiotherapy, the main treatments in both groups were exercise
TE D
therapy and physical agents (PE Group = 15 [71%], and GA Group = 13 [68%]). There were no statistically significant baseline differences between the study groups.
EP
A total of 396 treatment sessions were provided. In the Physiotherapy Exercise Group, 20 absences were recorded representing an attendance rate of 91.4% of the given
AC C
sessions. In the Graded Activity Group, 32 absences were recorded, representing an attendance rate of 91.9% of the sessions. Moreover, six participants dropped out (four refuse to continue the treatment and two traveled to another city) the treatment.
ACCEPTED MANUSCRIPT Table 1: Baseline characteristics of subjects by group Graded Activity Group
Group (n=33)
(n=33)
Age (years)
46.6 (9.5)
47.2 (10.5)
Weight (Kg)
69.4 (12.2)
71.8 (10.7)
Height (cm)
1.61 (0.09)
1.60 (0.08)
Body mass index (kg/m2)
26.7 (4.6)
27.8 (4.3)
Gender (Male/Female)
8 (24.2%); 25 (75.7%)
9 (27.2%); 24 (72.7%)
SC
Marital status
RI PT
Physiotherapy Exercise
4 (12.1)
Married
25 (73.7)
21 (63.6)
Divorced
2 (6.6)
1 (3.3)
Widow
2 (6.0)
1 (3.3)
48 [24-72]
24 [12-108]
Duration of low back pain
TE D
(months)* Academic level Primary education
Tertiary education Use of medication
EP
Secondary education
AC C
Physiotherapy treatment Pain intensity (0-10 cm) Disability (0-24)
10 (30.3)
M AN U
Single
20 (60.6)
22 (66.6)
12 (36.3)
10 (30.3)
1 (3.0)
1 (3.0)
18 (54.4)
14 (42.4)
21 (63.6)
19 (57.5)
7.2 (2.1)
7.6 (1.7)
13.7 (5.1)
12.9 (4.9)
The categorical variables are expressed as n (%) and the continuous variable are expressed as mean (SD) *Duration of symptoms is expressed as median [interquartile range];
P
S1356-689X(15)00021-1
DOI:
10.1016/j.math.2015.02.004
Reference:
YMATH 1682
To appear in:
Manual Therapy
Received Date: 6 August 2014 Revised Date:
6 February 2015
Accepted Date: 13 February 2015
Please cite this article as: Magalhães MO, Muzi LH, Comachio J, Burke TN, Renovato França FJ, Vidal Ramos LA, Almeida Leão GP, de Moura Campos Carvalho-e-Silva AP, Marques AP, The short-term effects of graded activity versus physiotherapy in patients with chronic low back pain: a randomized controlled trial, Manual Therapy (2015), doi: 10.1016/j.math.2015.02.004. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
ACCEPTED MANUSCRIPT
The short-term effects of graded activity versus physiotherapy in patients with chronic low back pain: a randomized controlled trial
Mauricio Oliveira Magalhães¹, Luzilauri Harumi Muzi¹, Josielli Comachio¹, Thomaz
RI PT
Nogueira Burke¹,³, Fabio Jorge Renovato França¹, Luiz Armando Vidal Ramos¹,4, Gabriel Peixoto Almeida Leão¹,², Ana Paula de Moura Campos Carvalho-e-Silva¹,
1
M AN U
SC
Amélia Pasqual Marques¹
Physical Therapy, Speech and Occupational Therapy Department, School of Medicine,
University of São Paulo, São Paulo, Brazil.
TE D
² Physical Therapy Division, School of Medicine, Federal University of Ceará, Ceará, Brazil.
³Bioscience Division, Federal University of São Paulo, São Paulo, Brazil University Federal do Amapá - Campus Binacional do Oiapoque, Amapá, Brazil.
EP
4
AC C
Corresponding author:
Mauricio Oliveira Magalhães Rua Cipotânea 51, Cidade Universitária Postal Code: 05360-160 São Paulo, SP, Brazil. E-mail: [email protected]
ACCEPTED MANUSCRIPT Abstract Background: Chronic low back pain is one of the most common problematic health conditions worldwide and is highly associated with disability, quality of life, emotional
RI PT
changes, and work absenteeism. Graded activity programs, based on cognitive behavioral therapy, and exercises are common treatments for patients with low back pain. However, recent evidence has shown that there is no evidence to support graded activity for patients with chronic nonspecific low back pain. Aim: to compare the
SC
effectiveness of graded activity and physiotherapy in patients with chronic nonspecific
M AN U
low back pain. Methods: A total of 66 patients with chronic nonspecific low back pain were randomized to perform either graded activity (moderate intensity treadmill walking, brief education and strength exercises) or physiotherapy (strengthening, stretching and motor control). These patients received individual sessions twice a week for six weeks. The primary measures were intensity of pain (Pain Numerical Rating
TE D
Scale) and disability (Rolland Morris Disability Questionnaire). Results: After six weeks, significant improvements have been observed in all outcome measures of both
EP
groups, with a non-significant difference between the groups. For intensity of pain (mean difference = 0.1 points, 95% confidence interval [CI] = -1.1 to 1.3) and disability
AC C
(mean difference = 0.8 points, 95% confidence interval [CI] = -2.6 to 4.2). No differences were found in the remaining outcomes. Conclusion: The results of this study suggest that graded activity and physiotherapy showed to be effective and have similar effects for patients with chronic nonspecific low back pain.
ACCEPTED MANUSCRIPT
1. INTRODUCTION Chronic nonspecific low back pain is one of the most common problematic
RI PT
health conditions worldwide and is highly associated with disability, poor quality of life, emotional changes, and work absenteeism (Airaksinen et al. , 2006, Delitto et al. , 2012). Chronic nonspecific low back pain accounts for 95% of cases of low back pain
SC
and is characterized by a defined etiology and the presence of symptoms for at least 12 weeks (Airaksinen, Brox, 2006). A recent systematic review reports that 39% of adults
M AN U
will experience at least one episode of back pain during their lifetime (Hoy et al. , 2012). The annual direct costs of chronic nonspecific low back pain in the United States range from $12.2 to $90.6 billion dollars, which represents only 14.5% of the total costs (Dagenais et al. , 2008). In Brazil, as the second most frequent health complaint, it is
al. , 2011).
TE D
estimated that 13.5% of the population suffers from chronic back problems (Barros et
In an attempt to reduce the impact associated with chronic nonspecific low back
EP
pain, certain treatments have been recommended by The European Guidelines for the Management of Chronic Low Back Pain as effective in the treatment of the condition,
AC C
such as manipulation/mobilization, acupuncture, back school, and multidisciplinary treatment (Airaksinen, Brox, 2006). Moreover, studies show that exercise therapy associated with education can been effective in reducing low back pain and disability (van der Roer et al. , 2008, van Middelkoop et al. , 2011). Among the methods used in exercise therapy are exercise and cognitive behavioral therapy (Airaksinen, Brox, 2006). Exercise programs may include the following kinds of exercise: aerobic, stretching, balance, motor control, coordination, and strengthening specific (e.g., the
ACCEPTED MANUSCRIPT transversus, abdominis, or multifidus) or global (e.g., the trunk, abdomen, or back) muscles (van Middelkoop et al. , 2010). Among these exercises, the practice of strengthening exercises, stretching, and motor control have shown good efficacy in reducing pain and disability in patients with chronic nonspecific low back pain
RI PT
(Airaksinen, Brox, 2006, Dufour et al. , 2010, Smith and Grimmer-Somers, 2010). A recent systematic review (Macedo et al. , 2009) shows that lumbar stabilization exercises are more effective than minimal intervention (booklet), yet the two have
SC
similar effects when compared to manual therapy or other types of exercises. A systematic review written by Macedo et al. (Macedo, Maher, 2009) recommends motor
M AN U
control exercises in conjunction with other types of exercise.
The cognitive behavioral therapy approach to low back pain uses interventions and counseling strategies to help change attitudes and inadequate beliefs that may negatively influence symptoms (Lamb et al. , 2010, Rundell and Davenport, 2010). The
TE D
cognitive behavioral model of treatment assumes that disability is determined not only by the underlying pathology, but also by social, cognitive, emotional, and behavioral factors. The graded activity program, based on the cognitive behavioral therapy, was
EP
developed based on studies suggesting that cognitive-behavioral aspects and operant conditioning principles can be used to reinforce healthy behaviors (Macedo et al. ,
AC C
2012). Moreover, the program was based on activities that each participant identified as problematic and that he or she could not perform or had difficulty performing because of back pain (Macedo, Latimer, 2012). The program focuses on functional activities and progress in a time-contingent manner regardless of pain to achieve functional goals and increased activity. Quotas, pacing, and self-reinforcement are key features of the program (Macedo, Latimer, 2012, Macedo et al. , 2010). Graded activity aims to reduce pain and disability by addressing pain-related fear, kinesiophobia, and unhelpful beliefs
ACCEPTED MANUSCRIPT and behaviors about back pain while correcting physical impairments such as reduced endurance, muscle strength, and balance (Leeuw et al. , 2008). A systematic review suggests that graded activity in the short-term and intermediate-term is slightly more effective than minimal intervention (i.e., usual care,
RI PT
waiting list, sham exercise, advice to stay active, or care by a general practitioner), yet is no more effective than other forms of exercise for persistent chronic nonspecific low back pain (Macedo, Smeets, 2010). However, among trials that compared graded
SC
activity with other forms of exercise, two treated patients with sub-acute low back pain (Anema et al. , 2007, Heymans et al. , 2006), two others had poor methodological
M AN U
quality (Critchley et al. , 2007, Nicholas et al. , 1991), and one trial conducted only one treatment session per week, which is questionable in terms of the optimal way to implement an intervention (Nicholas et al. , 1992). Although some studies show that graded activity are effective in reduce pain and disability in patients with chronic
TE D
nonspecific low back pain (Macedo, Latimer, 2012, van der Roer, van Tulder, 2008), recent systematic review has shown that, currently, there is insufficient evidence that graded activity is better for these outcomes in patients with non-specific LBP (van der
EP
Giessen et al. , 2012). Therefrom, more studies are necessary to evaluate the benefits are graded activity in patients with chronic nonspecific low back pain.
AC C
Therefore, the purpose of this study was to compare the effectiveness of graded
activity and physiotherapy in patients with chronic nonspecific low back pain.
2. Methods
2.1 Study Design This randomized controlled trial (RCT) recruited patients with chronic nonspecific low back pain. Patients were randomized into either Graded Activity (GA) Group or Physiotherapy Exercise (PE) Group. This study was approved by the ethics committee
ACCEPTED MANUSCRIPT of the School of Medicine of the University of Sao Paulo (Protocol 393/12), and was registered at clinicaltrials.gov (registration number: NCT01719276). All participants gave their informed consent before participation. 2.2 – Participants
RI PT
Sixty-six patients with chronic nonspecific low back pain diagnosed by an orthopedist were recruited from Specialized Rehabilitation Services at Taboão da Serra in Sao Paulo, Brazil. The inclusion criteria were as follows: chronic nonspecific low
SC
back pain, age between 18 and 65 years, and a minimum pain intensity score of three in the 11-point Pain Numerical Rating Scale (Costa et al. , 2008). Participants were
M AN U
excluded if they had any of the following criteria: known or suspected serious spinal pathology (e.g., fractures, tumors, inflammatory, rheumatologic disorders, or infective diseases of the spine), nerve root compromise, scheduled surgery, comorbid health conditions that would prevent active participation in the exercise programs, pregnancy,
TE D
or cardio-respiratory illnesses.
In order to ensure the patients’ safe participation in the study, the Physical Activity Readiness Questionnaire (PAR-Q) (Shephard, 1988) was used. Those
EP
answering “yes” to any of the questionnaire’s questions were excluded from the study.
AC C
2.3 – Randomization and blinding Simple randomization was conducted using Microsoft Excel for Windows software
(Microsoft Corporation, Redmond, Washington) by a researcher who was not involved in the recruitment of the participants. The allocation sequence was generated by one of the study’s authors, who was not involved with participant recruitment or treatment. The allocation was concealed by using consecutively numbered, sealed, opaque envelopes. After the baseline assessment, eligible participants were referred to the
ACCEPTED MANUSCRIPT physical therapist overseeing the treatment, who conducted their randomized allocation to the different treatments. The assessor was blind to the treatment allocation. Given the nature of the interventions, it was not possible for the therapist or the patients to be
RI PT
blinded.
2.4 - Sample size
The study’s sample size was designed in order to detect a two-point minimum
SC
difference between groups in terms of pain intensity outcome measured on the Pain Numerical Rating Scale, assuming a standard deviation of 1.9 points (Costa, Maher,
M AN U
2008). The study also sought to detect a 4-point difference in functional disability measured on the Roland Morris Disability Questionnaire, with an estimated standard deviation of 4.9 points (Costa, Maher, 2008, Costa et al. , 2007). Power was defined as 80% for an alpha of 5% and attrition (drop-outs) of 15%. The required sample was set at
2.5 - Assessment
TE D
33 patients per group.
EP
All measurements were conducted by a physical therapist blinded to the patient groups. A physiotherapist, who was unaware of the treatment allocation, screened
AC C
people in order to confirm eligibility criteria, as well as obtained demographic and anthropometric data. The investigator also assessed primary (pain intensity and disability) and secondary (quality of pain, quality of life, global perceived effect, return to work, physical activity, physical capacity, and kinesiophobia) outcomes. The Brazilian-Portuguese versions of the scales and questionnaires used in the study presented adequate psychometrical properties (Ciconelli et al. , 1999, Costa, Maher,
ACCEPTED MANUSCRIPT 2008, Florindo and Latore, 2003, Menezes Costa Lda et al. , 2011, Nusbaum et al. , 2001).
2.5.1 - Primary outcomes
RI PT
Pain
The Pain Numerical Rating Scale (NRS) is an 11-point scale ranging from 0 to 10, where 0 represents the absence of pain, and 10 represents unbearable pain (Costa,
SC
Maher, 2008). Participants were asked to focus assessment on their average pain levels
M AN U
over the week before assessment (Costa, Maher, 2008).
Disability
The Roland Morris Disability Questionnaire is a 24-item questionnaire dealing with normal activities of daily living. Participants were asked to tick the items that they
TE D
perceived as difficult to perform due to low back pain. Each answer is scaled either “no” (difficulty = 0 points) or “yes” (difficulty = 1 point), thus leaving a range of scores from 0 to 24, with a higher score indicating a higher level of disability (Costa, Maher, 2008,
EP
Costa, Maher, 2007, Nusbaum, Natour, 2001).
AC C
2.5.2 - Secondary Outcomes Quality of pain
The McGill Pain Questionnaire allows for a multidimensional assessment of pain. It consists of 78 descriptors assigned with intensity values that are grouped
into four major domains (sensory, affective, evaluative, and miscellaneous) and 20 subdomains, each with two to six descriptors. The questionnaire is used to describe pain experience and provides a total score that corresponds to the sum
ACCEPTED MANUSCRIPT of the values from each chosen descriptor. Maximal scores are as follows: sensorial = 41, affective = 14, evaluative = 5, miscellaneous = 17, total = 77 (Varoli and Pedrazzi, 2006).
RI PT
Quality of life
Health-related qualify of life (HRQoL) was assessed using the Short-Form Health Survey Questionnaire (SF-36), which consists of 36 questions grouped into eight
SC
domains: vitality (four items), physical functioning (ten items), bodily pain (two items), general health perception (five items), physical role functioning (two items), emotional
M AN U
role functioning (three items), social role functioning (two items), and mental health (five items). For each section, scores range from 0 to 100, with higher scores reflecting a better quality of life. The study focused on physical and emotional role functioning
TE D
(Ciconelli, Feraz, 1999).
Global Perceived Effect
Self-perception of treatment-associated improvement was measured with the
EP
global perceived effect scale. This 11-point numerical scale compares symptoms upon treatment’s end with those at pre-treatment. The scale ranges from -5 to +5, with
AC C
negative values reflecting a worsening of symptoms (-5 being the most significant in this sense), and positive values reflecting improvement (+5 reflecting total recovery) (Costa, Maher, 2008).
Return to Work
ACCEPTED MANUSCRIPT At post-treatment assessments, participants were asked if they were working. If the participants answered “no” to this question, they were further questioned if they were not working due to low back pain.
RI PT
Kinesophobia
The Tampa Scale of Kinesophobia (TSK) is a self-applied questionnaire consisting of 17 items that was developed to measure fear of movement due to chronic
SC
low back pain. Each question has four response options: totally disagree (1 point), partially disagree (2 points), partially agree (3 points), and totally agree (4 points). The
M AN U
scores of questions 4, 8, 12, and 16 were obtained through an inversion of the response values. The total score of the questionnaire corresponds to the sum of the scores of all questions and ranges from 17 to 68 points (de Souza et al. , 2008, Siqueira et al. , 2007).
TE D
Daily Physical Activity
The Baecke Questionnaire of Habitual Physical Activity measures physical activity in three domains: occupational activity, physical exercises, and leisure and
EP
locomotion. It consists of 16 questions structured using a quantitative Likert scale. The score is calculated by the sum of the domain scores. Physical activity is stratified as
AC C
mild (3.0-6.7), moderate (6.8-8.1) and intense (8.2-15.0) (Florindo and Latore, 2003).
Physical capacity
Sit-to-stand and 15.2m walking test was performed. Five repetitions of the sit-tostand test were used at maximal speed without use of the hands (Ocarino et al. , 2009). After five minutes, the walking test was performed. Patients walked 7.62m around two obstacles and returning to their initial position. Patients repeated the walking test after
ACCEPTED MANUSCRIPT an interval of three minutes, and the average value was used for analysis (Ocarino, Gonçalves, 2009). Time was measured using a digital manual stopwatch (instrutherm®).
RI PT
2.6 - Intervention
The intervention lasted six weeks, twice a week, totaling 12 hourly sessions. The Physiotherapy Exercise Group performed under the supervision of the researcher, and
SC
the participants were instructed to report any complaint related to the exercise. In addition, participants were instructed not to participate in any other intervention during
M AN U
the treatment period. There was no interference in the use of medication. The protocol for this study has been published previously (Magalhaes et al. , 2013).
2.6.1 – Physiotherapy Exercise Group
TE D
The protocol for the Physiotherapy Exercise Group was based on a protocol reported by França et al. (Franca et al. , 2012, Franca et al. , 2010) comprised of stretching (e.g., exercises focusing on the erector spinae, hamstrings, and triceps surae),
EP
strengthening (e.g., exercises focusing on the rectus abdominis, abdominus obliquus internus, and abdominus obliquus externus), and motor control exercises (e.g., exercises
AC C
focusing on the TrA and lumbar multifidus muscles). Moreover, Physiotherapy Exercise Group did not include interventions such as manual therapy.
2.6.2 - Graded Activity Group The Graded Activity Group followed protocols described by Macedo et al. (Macedo et al. , 2008) and Smeets et al. (Smeets et al. , 2006), both of which are founded on individual sessions of progressive and sub-maximal exercises that aim to
ACCEPTED MANUSCRIPT improve physical fitness and stimulate changes in behavior and attitude. The protocol of this group consisted of aerobic training on a treadmill and lower limb and trunk strengthening exercises. In the beginning of the treatment, patients selected one or two activities they considered difficult for them and received guidance on these throughout
RI PT
the treatment. Participants also received an educational booklet (based on the “Back Book”(Roland et al. , 1996) with important information on how to care for the spine. To determine the load of strengthening exercises, the 10-repetition maximum test was used
SC
(Navega et al. , 2006). During the first two weeks of training, individuals exercised using 50% of their maximum load. On the third and fourth week, the loads were made
M AN U
to be 60% maximum, and during the final two weeks, they were made to be 70% maximum. Heart rate (HR) was calculated using the formula of Karvonen (HRmax = 200 – age) for sedentary individuals: Exercise HR = Resting HR + 70% to 80% of maximum HR (McARDLE, 1997).
TE D
2.7 - Statistical Analysis
Data normality was assessed using the Kolmogorov–Smirnov test. A student ttest was used to test differences between groups at the baseline, and a two-way ANOVA
EP
(Group x Time) followed by Tukey’s post-hoc test were used for normal data after intervention. For non-normal data, the Wilcoxon signed-rank test was used. All
AC C
statistical tests were performed with the software SigmaStat 3.5 (Systat Software, Inc., Germany) and MS Excel Office 2007. The confidence interval was established at 95%, and the significant level at 5%. The relative gain with treatment was calculated using the following equation: RGi = (Baselinei − Endi) x 100 Baselinei
ACCEPTED MANUSCRIPT 3. Results Ninety-five subjects with chronic nonspecific low back pain were assessed for eligibility. Of these, 29 were excluded (Figure 1). Following this, 66 patients were assessed at baseline and randomly allocated into one of two groups (Physiotherapy
RI PT
Exercise Group = 33, or Graded Activity Group = 33). Post-analysis treatment was
SC
performed on 66 patients.
M AN U
Assessed for eligibility (n=95)
TE D
Enrollment
15 More than 65 years old 3 Nerve root compromise 3 Pregnancy 2 Pain intensity score < 3 4 Rheumatologic disorders 2 Scheduled Surgery
AC C
EP
Baseline assessement (n=66)
Randomized (n=66)
Allocation
Physiotherapy Exercise Group (n=33)
Graded Activity Group (n=33)
Discontinued Intervention
Discontinued Intervention
(N = 3)
(N = 3)
Analysis (n=30)
Analysis (n=30) Analysis
ACCEPTED MANUSCRIPT
Figure 1: Participant flow diagram
RI PT
The Physiotherapy Exercise Group consisted of 25 women and 8 men, with a mean age of 46.6 (9.5) years, while the graded activity group consisted of 24 women and 9 men, with a mean age of 47.2 (10.5) years. Table 1 shows the clinical and
SC
demographic characteristics of the participants. Participants allocated into the Graded Activity Group presented a greater duration of symptoms compared to the participants
M AN U
of the Physiotherapy Exercise Group. The main drugs used by the participants in both groups for symptom control were analgesics and anti-inflammatories (PE Group = 10 [55%], and GA Group = 9 [64%]). Furthermore, among the participants who had undergone previous physiotherapy, the main treatments in both groups were exercise
TE D
therapy and physical agents (PE Group = 15 [71%], and GA Group = 13 [68%]). There were no statistically significant baseline differences between the study groups.
EP
A total of 396 treatment sessions were provided. In the Physiotherapy Exercise Group, 20 absences were recorded representing an attendance rate of 91.4% of the given
AC C
sessions. In the Graded Activity Group, 32 absences were recorded, representing an attendance rate of 91.9% of the sessions. Moreover, six participants dropped out (four refuse to continue the treatment and two traveled to another city) the treatment.
ACCEPTED MANUSCRIPT Table 1: Baseline characteristics of subjects by group Graded Activity Group
Group (n=33)
(n=33)
Age (years)
46.6 (9.5)
47.2 (10.5)
Weight (Kg)
69.4 (12.2)
71.8 (10.7)
Height (cm)
1.61 (0.09)
1.60 (0.08)
Body mass index (kg/m2)
26.7 (4.6)
27.8 (4.3)
Gender (Male/Female)
8 (24.2%); 25 (75.7%)
9 (27.2%); 24 (72.7%)
SC
Marital status
RI PT
Physiotherapy Exercise
4 (12.1)
Married
25 (73.7)
21 (63.6)
Divorced
2 (6.6)
1 (3.3)
Widow
2 (6.0)
1 (3.3)
48 [24-72]
24 [12-108]
Duration of low back pain
TE D
(months)* Academic level Primary education
Tertiary education Use of medication
EP
Secondary education
AC C
Physiotherapy treatment Pain intensity (0-10 cm) Disability (0-24)
10 (30.3)
M AN U
Single
20 (60.6)
22 (66.6)
12 (36.3)
10 (30.3)
1 (3.0)
1 (3.0)
18 (54.4)
14 (42.4)
21 (63.6)
19 (57.5)
7.2 (2.1)
7.6 (1.7)
13.7 (5.1)
12.9 (4.9)
The categorical variables are expressed as n (%) and the continuous variable are expressed as mean (SD) *Duration of symptoms is expressed as median [interquartile range];
P
