Rheumatol Int (2014) 34:605–611 DOI 10.1007/s00296-013-2928-4
Original Article
A randomized placebo‑controlled clinical trial of phonophoresis for the treatment of chronic neck pain Dilek Durmus · Gamze Alayli · Tugce Tufekci · Omer Kuru
Received: 3 December 2013 / Accepted: 14 December 2013 / Published online: 28 December 2013 © Springer-Verlag Berlin Heidelberg 2013
Abstract The aim of this trial was to investigate and compare the effects of phonophoresis (PP), placebo PP and exercise therapies on pain, disability, sleep quality, and depression in the patients with chronic neck pain (CNP). This is a randomized, single-blind, placebo-controlled study. A total of 61 patients with definite CNP were included in this study. The patients were randomized into three groups. Group 1 (n = 21) received PP with capsaicin treatment and exercises. Group 2 (n = 20) received placebo PP with capsaicin and exercises. Group 3 (n = 20) was given only exercises. All of the programs were performed 3 days a week, for 6 weeks. The pain (visual analog scale), disability (the neck pain disability index), depression (Beck Depression Inventory scores), and sleep quality (Pittsburgh Sleep Quality Index) of all participants were evaluated. Measurements were taken before and after treatment. All of the groups showed statistically significant improvements in pain, disability, sleep quality, and depression. While there was no difference between groups regarding depression and sleep quality, intergroup comparison showed significant differences in pain and disability among three groups. These differences were statistically significant in group 1 and 2 compared to group 3, and also in group 1 compared to group 2. We observed that PP treatment was effective in the treatment for patients with CNP. A combination of PP with exercises can be used to obtain optimal clinical results.
D. Durmus (*) · G. Alayli · O. Kuru Department of Physical Medicine and Rehabilitation, Medical Faculty, Ondokuz Mayis University, Samsun, Turkey e-mail: [email protected] T. Tufekci Pharmacist, Medical Faculty, Ondokuz Mayis University, Samsun, Turkey
Keywords Chronic neck pain · Phonophoresis · Capsaicin · Exercise · Clinical parameters
Introduction Chronic neck pain (CNP) is a severe health problem in the general population, especially in industrial areas due to its high prevalence and frequent association with disability. Approximately 70 % of the adults experience neck pain during their lifetime, and it appears to be an important medical condition with its consequences. The pain gives rise to physical and psychological problems, disability, insomnia, depression, and deterioration in the quality of life [1]. Chronic neck pain has been found to be associated with certain postural, muscular, and mobility characteristics. Numerous etiologic factors have been linked to the condition: increased cervical lordosis, decreased muscle strength, imbalance between flexor, and extensor muscle strength [2]. There are different approaches involved in the treatment for the CNP. Exercise is frequently encountered as a central component of the treatment for patients with chronic pain and is also effective in the treatment for various chronic musculoskeletal pain disorders [3], including chronic low back pain [4, 5], CNP [2, 6], and fibromyalgia [7, 8]. Exercises have been established as wellness-focused coping strategies in the management of CNP. It is recently claimed that exercise therapy is effective in alleviating the pain and disability as well as increasing endurance and strength [1, 2]. Phonophoresis (PP) uses high-frequency sound waves (i.e., ultrasound) to deliver therapeutic medications, usually topical analgesics or steroids, through the skin to deeper tissues. Topically applied drugs therapeutic effects depend
13
606
on different factors such as rate, amount, drug penetration dept of the skin, and the potential drug toxicological hazards on the tissues. PP and US therapy has been used in musculoskeletal disorders and it is well tolerated, noninvasive, painless method [9, 10]. The PP therapy has been predominantly used as a painreduction modality in musculoskeletal disorders such as myofascial pain syndrome, knee osteoarthritis, carpal tunnel syndrome, tendinit, epicondilite, and tenosynovitis [9, 11–13]. Despite extensive clinical trials of PP, questions remain regarding treatment effectiveness [9, 11–15]. Additionally, to our knowledge, there is not any study in the literature investigating the effectiveness of PP in the treatment for CNP. The objective of this study was to determine and compare the effects of PP, placebo PP and exercise therapies on pain, disability, sleep quality, and depression in the patients with CNP.
Methods The present study was conducted at the Department of Physical Medicine and Rehabilitation of Medical Faculty of “Ondokuz Mayis University.” A total of 64 female patients who had been experiencing neck pain for at least 3 months were enrolled in the study. Sixty-one patients (61) completed the study (one patient in the PP group and one patient
Fig. 1 Flow diagram—overall plan of the study
13
Rheumatol Int (2014) 34:605–611
in the PP placebo group and one patient in the exercise group did not come to the assessment after 6 weeks; Fig. 1). A demographic data including age, body mass index (BMI; kg/m2), educational level, and duration of symptoms (years) were recorded. The subjects were housewives, employee, or they were retired (they had been living a sedentary life and had no regular or irregular sports habits). A complete examination was performed by the same physician. Study design This study was prospective, single blind, randomized controlled trial. Before treatment, the patients were informed about the purpose of the study and gave their consent. The study protocol was approved by the local ethics committee. Exclusion criteria were the following: patients (1) with acute radicular signs or symptoms, (2) who had radiographic evidence of inflammatory disease affecting the spine or tumor (3) with serious medical conditions for which exercise would be contraindicated, (4) with neuromuscular or dermatologic disease that involves the neck area, (5) who had exercise program that may cause increase in muscle strength within the previous 6 months (6) with implanted cardiac pacemaker or defibrillator, (7) with contracture, (8) with previous trauma, (9) with the history of the spinal surgery, (10) with the pregnancy, (11) with the presence of severe structural deformity, (12) with fibromyalgia, and (13) with myelopathy.
Rheumatol Int (2014) 34:605–611
Randomization The patients were randomized into three groups. Randomization was allocated by numbered envelopes method. The clinical evaluation of the patients before and after the treatment was made by the same physician (GA) who was blind to patients’ therapy. And the same physician (DD) who was blind to patients’ clinical data applied the therapy. Group 1 (n = 21) received PP with capsaicin treatment and exercises. Group 2 (n = 20) received placebo PP with capsaicin and exercises. Group 3 (n = 20) was given only exercises. All patients came to the outpatient department for PP, placebo PP, and exercise treatments. For PP, 10-min duration PP therapy was applied. For placebo PP group, 10-min duration placebo PP therapy was given. For three groups, 60-min duration exercise therapy was applied. All of the programs were performed 3 days a week, for duration of 6 weeks. Patients were evaluated before and at sixth weeks of the therapy. The use of NSAID, other analgesic drugs, and antidepressant drugs was not permitted during the study period; any pretreatment with these drugs had to be discontinued 7 days before the start of study. The use of other medication for comorbid diseases was permitted during study period. Phonophoresis therapy Ultrasound device (Enraf–Nonius Sonoplus 434) was used. Initially, topical gel containing capsaicin (10 % capsicum oleoresin 0.20 %) was applied circularly with a thickness of 2–3 mm. Then, ultrasound with a 5-cm-diameter applicator was applied over the paravertebral neck region with 1 MHz frequency and 1.5 Wt/cm2 power. The treatment duration was 10 min [9]. Placebo phonophoresis therapy The ultrasound probe was held over the paravertebral neck region using topical gel containing capsaicin (10 % capsicum oleoresin 0.20 %) which was the same as in group 2. Ultrasound device seemed to be working for 10-min period with light-off position [9]. Exercise therapy Exercises were taught by a physiatrist. The subjects in both groups were treated with a group-exercise program composed of 60-min servical, thoracic, lumbar, and abdominal exercises with a warm-up and cool-down period of 10 min stretching exercises 3 days a week under the supervision of the same physiatrist. All patients came to the outpatient department for exercise treatments. All patients were given neck exercise program including isotonic, isometric, and
607
stretching. Additionally, all patients were given an exercise program, which consisted of four exercises: (1) Motion, flexibility, and back strengthening exercises of the thoracic and lumbar spine; stretching of the erector spine muscle, hamstring muscles, pelvic muscles, and abdominal muscles: (a) pelvic tilt, (b) knee to chest, (c) lower abdominal exercises, (d) cat and camel, and (e) back extension exercises. (2) Special exercises to correct mobility of the spine and hip joints, activate the stabilizing muscles of the spine, and increase flexibility of the lower limb muscles. (3) Functional exercises to improve postural control, dynamic body balance, and coordination. (4) Progressive relaxation exercises to normalize muscle tension. Clinical assessments The patients were compared before and after the treatment, in accordance with pain, disability, sleep quality, and depression. Pain, disability, sleep quality, and depression were measured before treatment and at sixth weeks of the therapy. Pain and disability Patients were asked to point about intensity of the pain at resting and during activity on a 10 cm visual analog scale (VAS) indicating “0” is no pain and “10” is very severe pain. Neck pain disability scale (NPDI) was used to measure the disability. The NPDI is a self-administered questionnaire consisting of 20 items. The items measure the intensity of pain; its interference with vocational, recreational, social and functional aspects of living; and the presence and extent of associated emotional factors. The answers of the items are responded using a 10 cm VAS. It is divided into six divisions in equal intervals by vertical lines and signed with the numbers 0–5. Each item score ranges from 0 to 5, the total score ranges from 0 to 100, and higher values represent greater pain and disability [16]. Sleep quality The Pittsburgh Sleep Quality Index (PSQI) was used for the subjective assessment of sleep quality. The PSQI is a questionnaire consisting of 19 items which are coded on a 4-point scale (0–3) to obtain seven subcategories, including sleep duration, sleep disturbances, sleep latency, daytime dysfunction, sleep efficiency, sleep quality, and medication use. The sum of all sub scores represents the total sleep quality score, ranging between 0 and 21, with higher scores representing lower sleep quality. Respondents are asked to rate their sleep reflecting on the past month. The validity
13
608
Rheumatol Int (2014) 34:605–611
and reliability of the Turkish form of PSQI was performed by Agargun et al. [17]. Depression Depression was assessed with Beck Depression Inventory (BDI). BDI is a 21-item test presented in multiple-choice format, which purports to measure presence and degree of depression. Responses are made on a four-point, minimally anchored scale, ranging from 0 to 3, with 3 representing the most severe symptoms [18]. Statistical analysis Statistical analyses were performed with SPSS 16.0 for windows. Descriptive data were presented as mean ± standard deviation (SD) or minimum–maximum (median) when needed according to the normal distribution of the parameters. The Shapiro–Wilk test was used to analyze normal distribution assumption of the quantitative outcomes. Baseline, and after treatment clinical characteristics between groups were compared using the nonparametric Kruskal–Wallis and also Mann–Whitney U tests. Wilcoxon’s signed rank test or paired t test was used for within-group change used when needed according to the normal distribution of the parameters. The sociodemographical characteristics of the groups were evaluated by chi-square test. P values less than 0.05 were considered statistically significant.
Results Demographic properties of the patients are shown in Table 1. There was no statistically significant difference for age, gender, body mass index, duration of symptoms, and job between groups (P > 0.05). There was also no significant difference between the groups in terms of pain, disability, sleep quality, and depression scores before treatment (P > 0.05). All of the groups showed statistically significant improvements in pain, disability, sleep quality, and depression Table 1 Demographic properties of the patients
Discussion The aim of the treatment in the CNP is to decrease pain, to increase mobility, to prevent disability, and to improve sleep quality and physical functions. To attain these aims, various treatment programs are suggested. Medical treatment, physical therapy, superficial-deep heat applications, massage, traction, and exercises are the therapies often administered. The physical therapy modalities are usually used in combinations with exercises. The effects of the physical therapy modalities on the CNP have been shown in uncontrolled studies. There are few randomized controlled studies investigating the effect of these modalities, and there is no consensus on which treatment methods are more effective [19–22]. This study was planned as a randomized single-blind, placebo-controlled study in order to investigate the efficacy of PP, placebo PP and exercise methods on pain, disability, sleep quality, and depression in the patients with CNP. All of the groups showed significant improvements in disability, sleep quality, and depression. The intergroup comparison showed significant differences in pain and disability among three groups in favor of PP group. While using US, the gate control mechanism could be mentioned again due to excitation of A-β mechanoreceptors. In this condition, messages produced from mechanoreceptors enter the spinal cord, and quick pain impulses at the spinal cord become inhibited, and pain would be blocked [23]. Therapeutic US is proposed to deliver energy to deep tissue sites through ultrasonic waves, to produce increases in tissue temperature or nonthermal physiologic changes. Ultrasonic energy causes soft tissue molecules to vibrate from exposure to the acoustic wave. This increased molecular motion generates frictional heat, thus increasing tissue Group 1 (n = 21) mean ± SD
Age (year) Body mass index (kg/m2)
Group 2 (n = 20) mean ± SD
Group 3 (n = 20) mean ± SD
P
55.71 ± 1.00
54.15 ± 8.15
54.75 ± 8.09
0.795
27.80 ± 3.77 8.90 ± 6.15
26.95 ± 3.64 6.75 ± 6.35
26.35 ± 2.79 8.30 ± 5.89
0.412 0.227
n (%) Housewife Retired
7 (33.3) 9 (42.9)
6 (30.0) 10 (50.0)
9 (45.0) 9 (45.0)
0.744
Employee
5 (23.8)
4 (20.0)
2 (10.0)
Duration of symptoms (year) Job
13
scores when compared with their initial status (Table 2). The intergroup comparison showed significant differences in pain and disability among three groups. These differences were statistically significant in group 1 and 2 compared to group 3, and also in group 1 compared to group 2 (Table 3).
Rheumatol Int (2014) 34:605–611
609
Table 2 Baseline and the final results of clinical parameters of the patients Group 1 (n = 21)
Group 2 (n = 20)
BT
AT
Mean ± SD median (min–max)
Mean ± SD median (min–max)
VAS rest pain
P
Group 3 (n = 20)
BT
AT
Mean ± SD median (min–max)
Mean ± SD median (min–max)
P
P
BT
AT
Mean ± SD median (min–max)
Mean ± SD median (min–max)
4.50 ± 1.50 5 (1–6) VAS activity 6.65 ± 1.42 pain 7 (3–8) Total NPDS 31.10 ± 1.09 30 (18–56) BDI score 10.65 ± 5.33 11.5 (0–22) PSQI total 9.35 ± 4.10 9 (4–15) Sleep quality 1.45 ± 0.82 1 (0–3) Sleep latency 2.55 ± 1.84 2 (0–5) Duration of 1.20 ± 1.23 sleep 1 (0–3) Sleep efficiency 0.85 ± 1.30 0 (0–3) Sleep 2.00 ± 0.79 disturbance 2 (1–3) Day 1.20 ± 0.69 dysfunction 1 (0–3)
0.70 ± 0.73 1 (0–2) 1.65 ± 0.93 1.5 (0–4) 11.70 ± 4.50 11 (6–20) 5.50 ± 3.36 6 (0–13) 4.45 ± 2.08 4 (1–8) 0.70 ± 0.57 1 (0–2) 1.35 ± 1.03 1 (0–3) 0.70 ± 0.80 0.5 (0–2) 0.30 ± 0.57 0 (0–2) 0.95 ± 0.60 1 (0–2) 0.40 ± 0.50 0 (0–1)
0.001 3.95 ± 2.03 4.5 (2–8) 0.001 6.35 ± 1.89 7 (2–9) 0.001 32.70 ± 1.04 35 (12–52) 0.001 10.45 ± 3.77 11.5 (2–16) 0.001 9.75 ± 5.30 7.5 (2–20) 0.001 1.20 ± 0.89 1 (0–3) 0.001 2.25 ± 1.68 2 (0–5) 0.002 1.90 ± 1.02 2 (0–3) 0.015 1.20 ± 1.39 0.5 (0–3) 0.001 1.75 ± 0.71 2 (1–3) 0.001 1.10 ± 0.91 1 (0–3)
1.65 ± 0.93 1.5 (0–4) 3.00 ± 1.21 3 (0–5) 19.80 ± 6.51 20 (8–30) 5.25 ± 2.26 5 (0–9) 4.90 ± 2.88 4 (2–11) 0.60 ± 0.59 1 (0–2) 1.20 ± 0.95 1 (0–3) 1.15 ± 0.74 1 (0–2) 0.45 ± 0.68 0 (0–2) 0.95 ± 0.60 1 (0–2) 0.40 ± 0.50 0 (0–1)
0.001 3.85 ± 1.85 4 (2–8) 0.001 6.61 ± 1.74 7 (3–10) 0.001 33.52 ± 1.19 32 (10–60) 0.001 12.66 ± 5.92 14 (2–23) 0.001 8.71 ± 4.84 8 (2–16) 0.01 1.04 ± 0.86 1 (0–3) 0.01 2.28 ± 1.48 2 (0–5) 0.001 1.23 ± 1.22 1 (0–3) 0.004 1.42 ± 1.53 0 (0–3) 0.001 1.80 ± 0.67 2 (1–3) 0.01 0.80 ± 0.74 1 (0–2)
2.76 ± 1.57 3 (1–6) 4.95 ± 1.46 5 (2–8) 25.61 ± 9.85 22 (6–46) 6.57 ± 3.55 7 (0–13) 4.52 ± 3.05 4 (0–9) 0.57 ± 0.67 0 (0–2) 1.19 ± 0.92 1 (0–3) 0.71 ± 0.71 1 (0–2) 0.61 ± 0.74 0 (0–2) 1.04 ± 0.74 1 (0–3) 0.23 ± 0.43 0 (0–1)
0.001
Need medications to sleep
0.15 ± 0.36 0 (0–1)
0.049 0.60 ± 1.09 0 (0–3)
0.28 ± 0.35 0 (0–2)
0.024 0.28 ± 0.64 0 (0–2)
0.14 ± 0.47 0 (0–2)
0.049
0.20 ± 0.52 0 (0–2)
0.001 0.001 0.001 0.001 0.02 0.001 0.002 0.004 0.001 0.01
BT before treatment, AT after treatment, VAS pain visual analog scale, Total NPDS neck pain disability score, BDI Beck Depression Index, PSQI Pitsburg Sleep Quality Index, Mean ± SD mean ± standard deviation P
Original Article
A randomized placebo‑controlled clinical trial of phonophoresis for the treatment of chronic neck pain Dilek Durmus · Gamze Alayli · Tugce Tufekci · Omer Kuru
Received: 3 December 2013 / Accepted: 14 December 2013 / Published online: 28 December 2013 © Springer-Verlag Berlin Heidelberg 2013
Abstract The aim of this trial was to investigate and compare the effects of phonophoresis (PP), placebo PP and exercise therapies on pain, disability, sleep quality, and depression in the patients with chronic neck pain (CNP). This is a randomized, single-blind, placebo-controlled study. A total of 61 patients with definite CNP were included in this study. The patients were randomized into three groups. Group 1 (n = 21) received PP with capsaicin treatment and exercises. Group 2 (n = 20) received placebo PP with capsaicin and exercises. Group 3 (n = 20) was given only exercises. All of the programs were performed 3 days a week, for 6 weeks. The pain (visual analog scale), disability (the neck pain disability index), depression (Beck Depression Inventory scores), and sleep quality (Pittsburgh Sleep Quality Index) of all participants were evaluated. Measurements were taken before and after treatment. All of the groups showed statistically significant improvements in pain, disability, sleep quality, and depression. While there was no difference between groups regarding depression and sleep quality, intergroup comparison showed significant differences in pain and disability among three groups. These differences were statistically significant in group 1 and 2 compared to group 3, and also in group 1 compared to group 2. We observed that PP treatment was effective in the treatment for patients with CNP. A combination of PP with exercises can be used to obtain optimal clinical results.
D. Durmus (*) · G. Alayli · O. Kuru Department of Physical Medicine and Rehabilitation, Medical Faculty, Ondokuz Mayis University, Samsun, Turkey e-mail: [email protected] T. Tufekci Pharmacist, Medical Faculty, Ondokuz Mayis University, Samsun, Turkey
Keywords Chronic neck pain · Phonophoresis · Capsaicin · Exercise · Clinical parameters
Introduction Chronic neck pain (CNP) is a severe health problem in the general population, especially in industrial areas due to its high prevalence and frequent association with disability. Approximately 70 % of the adults experience neck pain during their lifetime, and it appears to be an important medical condition with its consequences. The pain gives rise to physical and psychological problems, disability, insomnia, depression, and deterioration in the quality of life [1]. Chronic neck pain has been found to be associated with certain postural, muscular, and mobility characteristics. Numerous etiologic factors have been linked to the condition: increased cervical lordosis, decreased muscle strength, imbalance between flexor, and extensor muscle strength [2]. There are different approaches involved in the treatment for the CNP. Exercise is frequently encountered as a central component of the treatment for patients with chronic pain and is also effective in the treatment for various chronic musculoskeletal pain disorders [3], including chronic low back pain [4, 5], CNP [2, 6], and fibromyalgia [7, 8]. Exercises have been established as wellness-focused coping strategies in the management of CNP. It is recently claimed that exercise therapy is effective in alleviating the pain and disability as well as increasing endurance and strength [1, 2]. Phonophoresis (PP) uses high-frequency sound waves (i.e., ultrasound) to deliver therapeutic medications, usually topical analgesics or steroids, through the skin to deeper tissues. Topically applied drugs therapeutic effects depend
13
606
on different factors such as rate, amount, drug penetration dept of the skin, and the potential drug toxicological hazards on the tissues. PP and US therapy has been used in musculoskeletal disorders and it is well tolerated, noninvasive, painless method [9, 10]. The PP therapy has been predominantly used as a painreduction modality in musculoskeletal disorders such as myofascial pain syndrome, knee osteoarthritis, carpal tunnel syndrome, tendinit, epicondilite, and tenosynovitis [9, 11–13]. Despite extensive clinical trials of PP, questions remain regarding treatment effectiveness [9, 11–15]. Additionally, to our knowledge, there is not any study in the literature investigating the effectiveness of PP in the treatment for CNP. The objective of this study was to determine and compare the effects of PP, placebo PP and exercise therapies on pain, disability, sleep quality, and depression in the patients with CNP.
Methods The present study was conducted at the Department of Physical Medicine and Rehabilitation of Medical Faculty of “Ondokuz Mayis University.” A total of 64 female patients who had been experiencing neck pain for at least 3 months were enrolled in the study. Sixty-one patients (61) completed the study (one patient in the PP group and one patient
Fig. 1 Flow diagram—overall plan of the study
13
Rheumatol Int (2014) 34:605–611
in the PP placebo group and one patient in the exercise group did not come to the assessment after 6 weeks; Fig. 1). A demographic data including age, body mass index (BMI; kg/m2), educational level, and duration of symptoms (years) were recorded. The subjects were housewives, employee, or they were retired (they had been living a sedentary life and had no regular or irregular sports habits). A complete examination was performed by the same physician. Study design This study was prospective, single blind, randomized controlled trial. Before treatment, the patients were informed about the purpose of the study and gave their consent. The study protocol was approved by the local ethics committee. Exclusion criteria were the following: patients (1) with acute radicular signs or symptoms, (2) who had radiographic evidence of inflammatory disease affecting the spine or tumor (3) with serious medical conditions for which exercise would be contraindicated, (4) with neuromuscular or dermatologic disease that involves the neck area, (5) who had exercise program that may cause increase in muscle strength within the previous 6 months (6) with implanted cardiac pacemaker or defibrillator, (7) with contracture, (8) with previous trauma, (9) with the history of the spinal surgery, (10) with the pregnancy, (11) with the presence of severe structural deformity, (12) with fibromyalgia, and (13) with myelopathy.
Rheumatol Int (2014) 34:605–611
Randomization The patients were randomized into three groups. Randomization was allocated by numbered envelopes method. The clinical evaluation of the patients before and after the treatment was made by the same physician (GA) who was blind to patients’ therapy. And the same physician (DD) who was blind to patients’ clinical data applied the therapy. Group 1 (n = 21) received PP with capsaicin treatment and exercises. Group 2 (n = 20) received placebo PP with capsaicin and exercises. Group 3 (n = 20) was given only exercises. All patients came to the outpatient department for PP, placebo PP, and exercise treatments. For PP, 10-min duration PP therapy was applied. For placebo PP group, 10-min duration placebo PP therapy was given. For three groups, 60-min duration exercise therapy was applied. All of the programs were performed 3 days a week, for duration of 6 weeks. Patients were evaluated before and at sixth weeks of the therapy. The use of NSAID, other analgesic drugs, and antidepressant drugs was not permitted during the study period; any pretreatment with these drugs had to be discontinued 7 days before the start of study. The use of other medication for comorbid diseases was permitted during study period. Phonophoresis therapy Ultrasound device (Enraf–Nonius Sonoplus 434) was used. Initially, topical gel containing capsaicin (10 % capsicum oleoresin 0.20 %) was applied circularly with a thickness of 2–3 mm. Then, ultrasound with a 5-cm-diameter applicator was applied over the paravertebral neck region with 1 MHz frequency and 1.5 Wt/cm2 power. The treatment duration was 10 min [9]. Placebo phonophoresis therapy The ultrasound probe was held over the paravertebral neck region using topical gel containing capsaicin (10 % capsicum oleoresin 0.20 %) which was the same as in group 2. Ultrasound device seemed to be working for 10-min period with light-off position [9]. Exercise therapy Exercises were taught by a physiatrist. The subjects in both groups were treated with a group-exercise program composed of 60-min servical, thoracic, lumbar, and abdominal exercises with a warm-up and cool-down period of 10 min stretching exercises 3 days a week under the supervision of the same physiatrist. All patients came to the outpatient department for exercise treatments. All patients were given neck exercise program including isotonic, isometric, and
607
stretching. Additionally, all patients were given an exercise program, which consisted of four exercises: (1) Motion, flexibility, and back strengthening exercises of the thoracic and lumbar spine; stretching of the erector spine muscle, hamstring muscles, pelvic muscles, and abdominal muscles: (a) pelvic tilt, (b) knee to chest, (c) lower abdominal exercises, (d) cat and camel, and (e) back extension exercises. (2) Special exercises to correct mobility of the spine and hip joints, activate the stabilizing muscles of the spine, and increase flexibility of the lower limb muscles. (3) Functional exercises to improve postural control, dynamic body balance, and coordination. (4) Progressive relaxation exercises to normalize muscle tension. Clinical assessments The patients were compared before and after the treatment, in accordance with pain, disability, sleep quality, and depression. Pain, disability, sleep quality, and depression were measured before treatment and at sixth weeks of the therapy. Pain and disability Patients were asked to point about intensity of the pain at resting and during activity on a 10 cm visual analog scale (VAS) indicating “0” is no pain and “10” is very severe pain. Neck pain disability scale (NPDI) was used to measure the disability. The NPDI is a self-administered questionnaire consisting of 20 items. The items measure the intensity of pain; its interference with vocational, recreational, social and functional aspects of living; and the presence and extent of associated emotional factors. The answers of the items are responded using a 10 cm VAS. It is divided into six divisions in equal intervals by vertical lines and signed with the numbers 0–5. Each item score ranges from 0 to 5, the total score ranges from 0 to 100, and higher values represent greater pain and disability [16]. Sleep quality The Pittsburgh Sleep Quality Index (PSQI) was used for the subjective assessment of sleep quality. The PSQI is a questionnaire consisting of 19 items which are coded on a 4-point scale (0–3) to obtain seven subcategories, including sleep duration, sleep disturbances, sleep latency, daytime dysfunction, sleep efficiency, sleep quality, and medication use. The sum of all sub scores represents the total sleep quality score, ranging between 0 and 21, with higher scores representing lower sleep quality. Respondents are asked to rate their sleep reflecting on the past month. The validity
13
608
Rheumatol Int (2014) 34:605–611
and reliability of the Turkish form of PSQI was performed by Agargun et al. [17]. Depression Depression was assessed with Beck Depression Inventory (BDI). BDI is a 21-item test presented in multiple-choice format, which purports to measure presence and degree of depression. Responses are made on a four-point, minimally anchored scale, ranging from 0 to 3, with 3 representing the most severe symptoms [18]. Statistical analysis Statistical analyses were performed with SPSS 16.0 for windows. Descriptive data were presented as mean ± standard deviation (SD) or minimum–maximum (median) when needed according to the normal distribution of the parameters. The Shapiro–Wilk test was used to analyze normal distribution assumption of the quantitative outcomes. Baseline, and after treatment clinical characteristics between groups were compared using the nonparametric Kruskal–Wallis and also Mann–Whitney U tests. Wilcoxon’s signed rank test or paired t test was used for within-group change used when needed according to the normal distribution of the parameters. The sociodemographical characteristics of the groups were evaluated by chi-square test. P values less than 0.05 were considered statistically significant.
Results Demographic properties of the patients are shown in Table 1. There was no statistically significant difference for age, gender, body mass index, duration of symptoms, and job between groups (P > 0.05). There was also no significant difference between the groups in terms of pain, disability, sleep quality, and depression scores before treatment (P > 0.05). All of the groups showed statistically significant improvements in pain, disability, sleep quality, and depression Table 1 Demographic properties of the patients
Discussion The aim of the treatment in the CNP is to decrease pain, to increase mobility, to prevent disability, and to improve sleep quality and physical functions. To attain these aims, various treatment programs are suggested. Medical treatment, physical therapy, superficial-deep heat applications, massage, traction, and exercises are the therapies often administered. The physical therapy modalities are usually used in combinations with exercises. The effects of the physical therapy modalities on the CNP have been shown in uncontrolled studies. There are few randomized controlled studies investigating the effect of these modalities, and there is no consensus on which treatment methods are more effective [19–22]. This study was planned as a randomized single-blind, placebo-controlled study in order to investigate the efficacy of PP, placebo PP and exercise methods on pain, disability, sleep quality, and depression in the patients with CNP. All of the groups showed significant improvements in disability, sleep quality, and depression. The intergroup comparison showed significant differences in pain and disability among three groups in favor of PP group. While using US, the gate control mechanism could be mentioned again due to excitation of A-β mechanoreceptors. In this condition, messages produced from mechanoreceptors enter the spinal cord, and quick pain impulses at the spinal cord become inhibited, and pain would be blocked [23]. Therapeutic US is proposed to deliver energy to deep tissue sites through ultrasonic waves, to produce increases in tissue temperature or nonthermal physiologic changes. Ultrasonic energy causes soft tissue molecules to vibrate from exposure to the acoustic wave. This increased molecular motion generates frictional heat, thus increasing tissue Group 1 (n = 21) mean ± SD
Age (year) Body mass index (kg/m2)
Group 2 (n = 20) mean ± SD
Group 3 (n = 20) mean ± SD
P
55.71 ± 1.00
54.15 ± 8.15
54.75 ± 8.09
0.795
27.80 ± 3.77 8.90 ± 6.15
26.95 ± 3.64 6.75 ± 6.35
26.35 ± 2.79 8.30 ± 5.89
0.412 0.227
n (%) Housewife Retired
7 (33.3) 9 (42.9)
6 (30.0) 10 (50.0)
9 (45.0) 9 (45.0)
0.744
Employee
5 (23.8)
4 (20.0)
2 (10.0)
Duration of symptoms (year) Job
13
scores when compared with their initial status (Table 2). The intergroup comparison showed significant differences in pain and disability among three groups. These differences were statistically significant in group 1 and 2 compared to group 3, and also in group 1 compared to group 2 (Table 3).
Rheumatol Int (2014) 34:605–611
609
Table 2 Baseline and the final results of clinical parameters of the patients Group 1 (n = 21)
Group 2 (n = 20)
BT
AT
Mean ± SD median (min–max)
Mean ± SD median (min–max)
VAS rest pain
P
Group 3 (n = 20)
BT
AT
Mean ± SD median (min–max)
Mean ± SD median (min–max)
P
P
BT
AT
Mean ± SD median (min–max)
Mean ± SD median (min–max)
4.50 ± 1.50 5 (1–6) VAS activity 6.65 ± 1.42 pain 7 (3–8) Total NPDS 31.10 ± 1.09 30 (18–56) BDI score 10.65 ± 5.33 11.5 (0–22) PSQI total 9.35 ± 4.10 9 (4–15) Sleep quality 1.45 ± 0.82 1 (0–3) Sleep latency 2.55 ± 1.84 2 (0–5) Duration of 1.20 ± 1.23 sleep 1 (0–3) Sleep efficiency 0.85 ± 1.30 0 (0–3) Sleep 2.00 ± 0.79 disturbance 2 (1–3) Day 1.20 ± 0.69 dysfunction 1 (0–3)
0.70 ± 0.73 1 (0–2) 1.65 ± 0.93 1.5 (0–4) 11.70 ± 4.50 11 (6–20) 5.50 ± 3.36 6 (0–13) 4.45 ± 2.08 4 (1–8) 0.70 ± 0.57 1 (0–2) 1.35 ± 1.03 1 (0–3) 0.70 ± 0.80 0.5 (0–2) 0.30 ± 0.57 0 (0–2) 0.95 ± 0.60 1 (0–2) 0.40 ± 0.50 0 (0–1)
0.001 3.95 ± 2.03 4.5 (2–8) 0.001 6.35 ± 1.89 7 (2–9) 0.001 32.70 ± 1.04 35 (12–52) 0.001 10.45 ± 3.77 11.5 (2–16) 0.001 9.75 ± 5.30 7.5 (2–20) 0.001 1.20 ± 0.89 1 (0–3) 0.001 2.25 ± 1.68 2 (0–5) 0.002 1.90 ± 1.02 2 (0–3) 0.015 1.20 ± 1.39 0.5 (0–3) 0.001 1.75 ± 0.71 2 (1–3) 0.001 1.10 ± 0.91 1 (0–3)
1.65 ± 0.93 1.5 (0–4) 3.00 ± 1.21 3 (0–5) 19.80 ± 6.51 20 (8–30) 5.25 ± 2.26 5 (0–9) 4.90 ± 2.88 4 (2–11) 0.60 ± 0.59 1 (0–2) 1.20 ± 0.95 1 (0–3) 1.15 ± 0.74 1 (0–2) 0.45 ± 0.68 0 (0–2) 0.95 ± 0.60 1 (0–2) 0.40 ± 0.50 0 (0–1)
0.001 3.85 ± 1.85 4 (2–8) 0.001 6.61 ± 1.74 7 (3–10) 0.001 33.52 ± 1.19 32 (10–60) 0.001 12.66 ± 5.92 14 (2–23) 0.001 8.71 ± 4.84 8 (2–16) 0.01 1.04 ± 0.86 1 (0–3) 0.01 2.28 ± 1.48 2 (0–5) 0.001 1.23 ± 1.22 1 (0–3) 0.004 1.42 ± 1.53 0 (0–3) 0.001 1.80 ± 0.67 2 (1–3) 0.01 0.80 ± 0.74 1 (0–2)
2.76 ± 1.57 3 (1–6) 4.95 ± 1.46 5 (2–8) 25.61 ± 9.85 22 (6–46) 6.57 ± 3.55 7 (0–13) 4.52 ± 3.05 4 (0–9) 0.57 ± 0.67 0 (0–2) 1.19 ± 0.92 1 (0–3) 0.71 ± 0.71 1 (0–2) 0.61 ± 0.74 0 (0–2) 1.04 ± 0.74 1 (0–3) 0.23 ± 0.43 0 (0–1)
0.001
Need medications to sleep
0.15 ± 0.36 0 (0–1)
0.049 0.60 ± 1.09 0 (0–3)
0.28 ± 0.35 0 (0–2)
0.024 0.28 ± 0.64 0 (0–2)
0.14 ± 0.47 0 (0–2)
0.049
0.20 ± 0.52 0 (0–2)
0.001 0.001 0.001 0.001 0.02 0.001 0.002 0.004 0.001 0.01
BT before treatment, AT after treatment, VAS pain visual analog scale, Total NPDS neck pain disability score, BDI Beck Depression Index, PSQI Pitsburg Sleep Quality Index, Mean ± SD mean ± standard deviation P
