File
Sharma S1,2, Jensen MP3, Moseley GL4, Abbott JH2
1Kathmandu University School of Medical Sciences, Department of Physiotherapy, Dhulikhel, Nepal, 2University of Otago, Department of Surgical Sciences, Dunedin, New Zealand, 3University of Washington, Department of Rehabilitation Medicine, Seattle, United States, 4University of South Australia, School of Health Sciences, Adelaide, Australia
Background: Patient education is a recommended treatment for low back pain (LBP). Formalized, structured patient education programs such as pain education (PE) are used as a treatment for LBP in western countries. However, the applicability of this approach in the Eastern cultures (example, Nepalese) is not known due to cultural and language differences. Therefore, the educational contents of such programs first should be adapted to the new culture, and then tested in a randomized clinical trial (RCT), before it is used in clinical practice.
Purpose: The aims of the study were to
(1) cross-culturally adapt an evidence-based PE treatment program to Nepali and
(2) evaluate the feasibility of conducting an RCT to evaluate its effectiveness.
Methods: We first developed a PE package in Nepali using the established “Explain Pain” resources developed in Australia. We used Nepalese patients' pain stories and metaphors to improve cultural relevance. We then conducted a two-arm, assessor-blinded, feasibility RCT in 40 individuals with non-specific LBP from Nepal (ClinicalTrials.gov: NCT03387228). Participants were randomized to either PE or a guideline-based treatment condition. The primary feasibility outcome measures were related to recruitment rate (>4 participants/week), attrition rate (>70% retention at follow-up), assessor blinding, and treatment delivery (acceptability and credibility of treatment, lack of contamination, adherence to treatment). We also used eight valid and reliable secondary clinical outcome measures to assess pain intensity, pain interference, pain catastrophizing, sleep disturbance, resilience, depression, global rating of change, and quality of life at baseline and 1-week follow-up to determine which might be best to use in a potential future definitive trial.
Results: We screened 70 participants to recruit our target of 40 participants, exceeding the minimum rate of four participants/week. Attrition at 1 week was 5%. The assessor blinding was successful as he/she did not receive any information about participants' group allocation. The participants indicated that Nepali PE was comprehensible, and was acceptable treatment of LBP in Nepalese. The credibility scores of the two treatment conditions were within 0.50 SD of each other, meeting the a priori criteria for feasibility. There was no detected contamination between groups. Adherence to treatment (89%) was acceptable as it surpassed our a priori goal of minimum 50% adherence. The results on the clinical measures indicate that PE is more effective in reducing pain intensity (mean difference: 3.56 (95% CI: 0.21, 6.91)) and pain catastrophizing (mean difference: 6.16 (0.59, 11.72)) than the guideline-based control condition.
Conclusion(s): The Nepali PE resource was successfully developed and was accepted as a credible treatment for LBP. We conclude that an RCT to evaluate effectiveness of PE in Nepalese with LBP is feasible in Nepal.
Implications: The results inform recommendations for a future definitive trial. For example, pain intensity would be an appropriate primary outcome variable for our planned definitive RCT in future. Should PE be found to be effective in a future clinical trial, it could become an important aspect of management of LBP in Nepal, and also be adapted for other musculoskeletal conditions.
Keywords: Patient education, Back pain, Culture
Funding acknowledgements: SS is supported by University of Otago Doctoral Scholarship. Funding was not secured for this project.
Purpose: The aims of the study were to
(1) cross-culturally adapt an evidence-based PE treatment program to Nepali and
(2) evaluate the feasibility of conducting an RCT to evaluate its effectiveness.
Methods: We first developed a PE package in Nepali using the established “Explain Pain” resources developed in Australia. We used Nepalese patients' pain stories and metaphors to improve cultural relevance. We then conducted a two-arm, assessor-blinded, feasibility RCT in 40 individuals with non-specific LBP from Nepal (ClinicalTrials.gov: NCT03387228). Participants were randomized to either PE or a guideline-based treatment condition. The primary feasibility outcome measures were related to recruitment rate (>4 participants/week), attrition rate (>70% retention at follow-up), assessor blinding, and treatment delivery (acceptability and credibility of treatment, lack of contamination, adherence to treatment). We also used eight valid and reliable secondary clinical outcome measures to assess pain intensity, pain interference, pain catastrophizing, sleep disturbance, resilience, depression, global rating of change, and quality of life at baseline and 1-week follow-up to determine which might be best to use in a potential future definitive trial.
Results: We screened 70 participants to recruit our target of 40 participants, exceeding the minimum rate of four participants/week. Attrition at 1 week was 5%. The assessor blinding was successful as he/she did not receive any information about participants' group allocation. The participants indicated that Nepali PE was comprehensible, and was acceptable treatment of LBP in Nepalese. The credibility scores of the two treatment conditions were within 0.50 SD of each other, meeting the a priori criteria for feasibility. There was no detected contamination between groups. Adherence to treatment (89%) was acceptable as it surpassed our a priori goal of minimum 50% adherence. The results on the clinical measures indicate that PE is more effective in reducing pain intensity (mean difference: 3.56 (95% CI: 0.21, 6.91)) and pain catastrophizing (mean difference: 6.16 (0.59, 11.72)) than the guideline-based control condition.
Conclusion(s): The Nepali PE resource was successfully developed and was accepted as a credible treatment for LBP. We conclude that an RCT to evaluate effectiveness of PE in Nepalese with LBP is feasible in Nepal.
Implications: The results inform recommendations for a future definitive trial. For example, pain intensity would be an appropriate primary outcome variable for our planned definitive RCT in future. Should PE be found to be effective in a future clinical trial, it could become an important aspect of management of LBP in Nepal, and also be adapted for other musculoskeletal conditions.
Keywords: Patient education, Back pain, Culture
Funding acknowledgements: SS is supported by University of Otago Doctoral Scholarship. Funding was not secured for this project.
Topic: Pain & pain management; Musculoskeletal: spine; Musculoskeletal
Ethics approval required: Yes
Institution: Nepal Health Research Council
Ethics committee: Nepal Health Research Council Ethics Board
Ethics number: 422/2017
All authors, affiliations and abstracts have been published as submitted.
