ORIGINAL ARTICLE. Sedigheh Sadat TAVAFIAN, 1 Ahmad Reza JAMSHIDI 2 and Kazem MOHAMMAD 3. Abstract INTRODUCTION

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1 International Journal of Rheumatic Diseases 2014; 17: ORIGINAL ARTICLE Treatment of low back pain: randomized clinical trial comparing a multidisciplinary group-based rehabilitation program with oral drug treatment up to 12 months Sedigheh Sadat TAVAFIAN, 1 Ahmad Reza JAMSHIDI 2 and Kazem MOHAMMAD 3 1 Department of Health Education, Faculty of Medical Sciences, Tarbiat Modares University, 2 Rheumatology Research Center, Tehran University of Medical Sciences, and 3 Department of Epidemiology and Biostatistics, Tehran University of Medical Sciences, Tehran, Iran Abstract Background: This study aimed to examine the effects of a multidisciplinary treatment program on health-related quality of life of Iranian patients living with chronic low back, at 12 months follow-up. Methods: This study is an extended follow-up of an original randomized, controlled trial with registration number NCT In the present study 87 patients in an intervention group and 91 patients in a control group were assessed at 12 months follow-up. The intervention was a group-based multidisciplinary rehabilitation program which continued by monthly motivational consultation by telephone from 6 to 12 months after intervention. Data from three standard measures, Short Form 36 (SF-36), QDS and RDQ were collected at 3, 6 and 12 months follow-up and analyzed through repeated measures analysis of variance. Results: Despite the similarity between the two groups who completed the 6 month follow-up in terms of all baseline variables, there were significant differences between the two groups in all domains of the SF-36 scale, as well as QDS and RDQ scales (P < 0.05). Also, there were differences within each group over time in the SF-36 domains and disability measurements (P < 0.05). The physical function mean score differed significantly when the interaction between groups and time points was examined (P = 0.02). Conclusion: This study indicates that the multidisciplinary program could improve the domains of health related quality of life and disability in chronic low back pain patients up to 12 months. Key words: chronic low back pain, clinical trial study, health-related quality of life, Iran, multidisciplinary treatment. INTRODUCTION There is evidence showing that multidisciplinary, biopsychosocial rehabilitation with functional restoration can reduce pain and improve function in chronic low back pain (CLBP) patients. 1,2 In addition, research has demonstrated the effectiveness of a group-based Correspondence: Ahmad Reza Jamshidi, MD, Rheumatology Research Center, Shariati Hospital, P.O. Box 14114, Tehran, Iran. jamshida@sina.tums.ac.ir multidisciplinary rehabilitation program on long-term improvement in pain, disability and work participation at 1 year follow-up. 2,3 However, the evidence of beneficial effects of multidisciplinary treatment on functional improvement and return to work versus waiting list control, usual care and non-multidisciplinary treatment is inconclusive. 3 Previous studies have argued that Iranian CLBP patients usually suffer from depression, anxiety and daily stresses due to cultural and social characteristics of their lives, 4 6 as well as lack of knowledge and skills to improve their pain and disability Asia Pacific League of Associations for Rheumatology and Wiley Publishing Asia Pty Ltd

2 S. S. Tavafian et al. To address these gaps, the researchers of this study designed a multidisciplinary pain management program 7 in which different specialists, such as physiotherapists, rheumatologists, health education specialists and psychologists addressed all bio-psychosocial aspects of CLBP. These researchers showed this program could improve health-related quality of life (HRQoL) of patients up to 6 months after intervention. 7 Here we report the results of 12 months follow-up of the participants who took part in a previously reported study. 7 We hypothesized that this described program has potential capability to improve HRQoL and reduce disability of Iranian patients with CLBP up to 12 months. MATERIALS AND METHODS This study is an extended follow-up of an original randomized, controlled trial with registration number NCT which was conducted at the Rheumatology Research Center of Tehran University of Medical Sciences (TUMS) in Tehran, Iran. The study design, characteristics of the patients, including inclusion/exclusion criteria, the strategy of patient selection and randomization as well as the measurements and study intervention are reported in detail elsewhere. 7 In the present study, the patients who completed 6 months follow-up in the previous study 7 were followed up to 12 months. At this time point four patients from the intervention group and three patients from the control group were not accessible. Furthermore, one patient from the intervention and two patients from the control group were not eligible to continue the study. Thus, 87 patients in the intervention group and 91 patients in the control group were assessed 12 months post-intervention. The intervention was a group-based multidisciplinary rehabilitation program which involved one 2-h theoretical physiotherapy class followed by 1 h of practical physiotherapy, and three 2-h rheumatology, psychology and health education classes. The intervention classes were provided for patients as group sessions and administered by team members from different specialties. All five initial classes were administered and finished over 1 week. Afterward, the participants were provided with monthly booster class and telephone counseling to continue improved behaviors. This program has previously been well explained. 7 In this extended follow-up study, patients were followed up to 12 months by monthly motivational consultation via telephone. Usually, during this further 6 months the participants in both groups were evaluated every 3 months by the same rheumatologist who was involved initially in the study. The participants of both groups could see the physician earlier if they requested. Throughout this follow-up, medications such as nonsteroidal anti-inflammatory drugs (NSAIDs) like diclofenac and naproxen, muscle relaxants and antidepressant drugs, were prescribed for patients of both groups as needed. The type and dosages of medications were based only on the clinical findings as diagnosed by the physician. As prescribing opioids is illegal in Iran, these drugs were not prescribed for the participants of this study. The multidisciplinary rehabilitation program was administered only to the intervention group. Consolidated Standards of Reporting Trials (CONSORT) guidelines 8 were applied for this trial study. Outcome variables Outcome variables were the eight domains of HRQoL measured by the Short Form 36 (SF-36) questionnaire and disabilities measured using Ronald-Morris Disability (RDQ) and Quebec Disability Scale (QDS) instruments. Statistical analysis All data analyses were conducted according to the preestablished analysis plan that was explained in a previous work. 7 Intention-to-treat analysis was performed to compare the participants who continued the study with those who did not. RESULTS In the present study, 87 participants from the intervention group with mean age of years and 91 participants from the control group with mean age of years completed the study up to 12 months post-intervention. Intention-to-treat analysis showed there were no significant differences between those who completed the study and those who did not. Table 1 shows the two groups who completed 12 months follow-up were the same in terms of baseline variables (all P > 0.05). As mentioned in the original study, the patients would be followed at 3, 6, 12, 18, 24, 30 and 36 months follow-up. Therefore, there was no assessment at 9 months after intervention. Table 2 shows the results from repeated measures analysis of variance (ANOVA). As shown here, there are significant differences between two groups in all SF-36 domain scales as well as QDS and RDQ scales (P < 0.05). Differences in outcomes within groups over 160 International Journal of Rheumatic Diseases 2014; 17:

3 Treatment of chronic low back pain time were also examined through this analysis. According to the results, there were differences within each group over time in the SF-36 domains and disability measurements (P < 0.05). As shown in this table, just the mean score of physical function differed significantly when the interaction between groups and time points was examined (P = 0.02). DISCUSSION This study showed patients who received the multidisciplinary program had better outcomes up to 12 months than those who received just usual care, with respect to HRQoL and disability. As shown, during this time both groups improved. However, improvements on all HRQoL domains were significantly greater in the intervention group than the other group. Thus, it could be argued that the bio-psychosocial characteristics of the program promoted QoL and improved participants disabilities in the intervention group. The previous systematic review found that intensive (> 100 h of therapy) multidisciplinary bio-psychosocial rehabilitation could significantly decrease pain and improve function compared with non-multidisciplinary treatments or usual care. 9 However, the designed multidisciplinary treatment in our study was a less intensive program presented in initial classes and was followed by monthly booster classes and telephone counseling. Our results are also similar to that reported in a previous study 10 which compared the multidisciplinary approach with usual care. In that study 10 the program was implemented for 4 h/day over 3 days per week to a total of 20 days, which was organized by a team of local health care providers with different specialties, such as sports teachers, clinical psychologists, physiotherapists and physicians. The multidisciplinary program in the Table 1 The baseline characteristics of the studied patients who completed 12 months follow-up Intervention (n = 87) Control (n = 91) P Mean (SD) n (%) Mean (SD) n (%) Age (years) 44.6 (10.5) 46.2 (10.9) 0.30 Weight (kg) 71.8 (11.2) 72.3 (12.19) 0.72 Education (years) 12.4 (4.6) 11.5 (4.5) 0.21 Gender 0.3 Female 65 (74.7) 75 (82.4) 0.21 Male 22 (25.3) 16 (17.6) Marital status 0.17 Married 75 (86.2) 76 (83.5) Single 9 (10.3) 6 (6.6) Widower/divorced 3 (3.4) 9 (9.9) Smoking 0.47 Yes 5 (5.7) 4 (4.4) No 82 (94.3) 87 (95.6) Sciatica 0.54 Yes 74 (85.1) 77 (85.6) No 13 (14.9) 13 (14.4) Duration of pain (months) 70.4 (66.7) (112.0) 0.09 Duration of pain 42.2 (55.8) 51.1 (79.2) 0.38 treatment (months) Physical function Role physical Bodily pain General health Vitality Social function Role emotional Mental health QDS RDQ International Journal of Rheumatic Diseases 2014; 17:

4 S. S. Tavafian et al. Table 2 Repeated measures ANOVA of SF-36 subscales, QDS and RDQ SF-36 Domains Intervention M (SD) N = 87 Control M (SD) N = 91 Group difference Time difference Physical function 3 months follow-up (22.6) (22.3) < < months follow up 78.3 (17.9) 63.5 (22.2) 12 months follow up 80.3 (18.6) 64.4 (22.8) Role physical 3 months follow-up 58.9 (69.5) 38.7 (38.7) <0.07 < months follow-up 66.7 (36.1) 45.9 (38.9) 12 months follow-up 72.4 (37.3) (38.4) Bodily pain 3 months follow-up 66.4 (22.4) 57.3 (22.7) < months follow-up 72.5 (22.8) 61.7 (25.2) 12 months follow-up 69.5 (18.3) 56.2 (21.3) General health 3 months follow-up 59.8 (21.4) 53.1 (23.1) < months follow-up 61.8 (22.03) 63.5 (22.9) 12 months follow-up 69.6 (21.7) 59.9 (24.3) Vitality 3 months follow-up (22.2) 54.3 (21.7) 0.01 < months follow-up 66.8 (21.1) 59.8 (22.6) 12 months follow-up 70.3 (22.5) 63.1 (22.5) Social Function 3 months follow-up 60.7 (20.6) 79.5 (20.4) < months follow-up 77.8 (22.4) 69.6 (27.7) 12 months follow-up 81.6 (19.3) (27.4) Role Emotional 3 months follow-up 52.4 (44.7) 42.1 (44.4) months follow-up 60.1 (9/45) 50.5 (46.2) 12 months follow-up 72.4 (42.3) 53.1 (46.6) Mental Health 3 months follow-up (20.4) 58.3 (23.1) months follow-up 67.2 (22.1) 60.9 (23.4) 12 months follow-up 71.8 (20.2) 58.9 (24.9) QDS 3 months follow-up 25.6 (19.5) 32.1 (17.3) < months follow-up 19.6 (16.02) 26.9 (17.6) 12 months follow-up 17.4 (16.4) 24.4 (18.3) RDQ 3 months follow-up 8.9 (6.5) 10.5 (8.5) < months follow-up 8.6 (5.3) 8.8 (5.5) 12 months follow-up 6.01 (5.8) 8.9 (6.6) Group 9 time difference present study was less intensive but provided booster classes and telephone counseling in which all learned behaviors and skills were reviewed. Additionally, the previously mentioned study followed patients for just 6 months. However, our results are different from that reported by Vollenbroek-Hutten 11 who found no improvement in function or HRQoL after 2 or 6 months. This difference may be due to the study regime of a back-to-school multidisciplinary program applied in that study, 11 which was a physically oriented program, while in our study we designed a biopsychosocial program that focused on physical dimensions of CLBP as well as its mental and social aspects. As reported previously, 7 there were no significant differences between the two groups over time in terms of mental health at 6 months follow-up, while the mental 162 International Journal of Rheumatic Diseases 2014; 17:

5 Treatment of chronic low back pain health of patients receiving the program was significantly improved at 12 months follow-up. This success of the program might be attributed to continued monthly motivational telephone counseling to encourage patients to use stress management techniques in their daily life. This finding is in line with previous evidence revealing that continual motivation of individuals can lead to change in unhealthy behaviors Additionally, it has been argued that providing low back pain patients with meaningful information could have positive impact on pain, medication use, patient satisfaction and overall improvement. 15 However, the present study showed the interaction of time with group was not significant in all studied variables, except for physical function. This result might be due to extending the follow-up through which the patients might forget the knowledge and skills which were instructed in the classes. However, in this study, in contrast with our previous one, 7 the baseline data were not entered to the model of repeated measures analysis in order to show the exact difference between the two groups over time after intervention. However, this study aimed to show the trend of improvements in both groups over time from 3 to 12 months follow-up. Therefore, the data from 3 months follow-up were considered as the first stage of analysis. Although this study showed that the mental health of the intervention group improved from 6 to 12 months, it might be argued that some of these improvements might be due to not adequately blinding patients to the intervention. Although it was impractical to mask the patients fully because of the nature of the intervention, attempts were made to hide patients from knowing about the comparison being made of the two groups. In a previous systematic review, 16 it was reported that of 27 studied trials regarding multidisciplinary treatment for chronic pain, just three studies (11.1%) were conducted on adequately blinded participants. In this study just one physician who was not fully masked to the intervention, treated the patients; this limitation could not actually affect the results, because the physician only examined the patients and prescribed the medications only based on clinical findings. On the other hand, the patients were well instructed to say nothing about their group assignment to the physician. However, because of the nature of the study, full masking of the physician was limited in this study. In the present study, there is no independent data to show what percentage of patients in each group were prescribed muscle relaxants and other forms of pain relief or what percentage of the patients in the intervention group actually exercised regularly. There is no real information regarding any other received interventions beyond those provided by the physician. Although, during counseling, the patients confirmed complying with the physician s and other specialists recommendations, and the patients also accepted only these recommendations, it might be argued that these limitations could have some affect on results. ACKNOWLEDGEMENTS The authors thank the Research Deputy of Tehran University of Medical Sciences for its financial support. They also thank all patients who cooperated with the researchers and complied with the protocol of the study. The author would like to thank Dr Sue Patterson, PhD, Research Fellow from Imperial College London, Department of Primary Care and Public Health for editing the manuscript. This work was funded by the Research Deputy of Tehran University of Medical Sciences. CONFLICTS OF INTEREST The authors declare that they have no conflicts of interest. TRIAL REGISTRATION Registered at with trial registration number NCT REFERENCES 1 Kaapa EH, Frantsi K, Sarna S, Malmivaara A (2006) Multidisciplinary group rehabilitation versus individual physiotherapy for chronic nonspecific low back pain: a randomized trial. Spine 31, Dufour N, Thamsborg G, Oefeldt A, Lundsgaard C, Stender S (2010) Treatment of chronic low back pain: a randomized, clinical trial comparing group based multidisciplinary biosychosocial rehabilitation and intensive individual therapist assisted back muscle straitening exercises. Spine 35, Chou R. (2010) Low back pain (chronic). Clin Evid 2010: (Available at URL: pmc/articles/pmc /) 4 Mousavi SJ, Akbari ME, Mehdian H et al. (2011) Low back pain in Iran: a growing need to adapt and implement evidence based practice in developing countries. Spine 36, International Journal of Rheumatic Diseases 2014; 17:

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