Journal Article

Results of a feasibility randomised clinical trial on pain education for low back pain in Nepal: the Pain Education in Nepal-Low Back Pain (PEN-LBP) feasibility trial

Sharma, Saurab, Abbott, J Haxby, Moseley, G Lorimer, Jensen, Mark P

2019

Overview

ObjectivesThe aims of this study were to: (1) develop pain education materials in Nepali and (2) determine the feasibility of conducting a randomised clinical trial (RCT) of a pain education intervention using these materials in Nepal.DesignA two-arm, parallel, assessor-blinded, feasibility RCT.SettingA rehabilitation hospital in Kathmandu, Nepal.ParticipantsForty Nepalese with non-specific low back pain (mean [SD] age 41 [14] years; 12 [30%] women).InterventionsEligible participants were randomised, by concealed, 1:1 allocation, to one of two groups: (1) a pain education intervention and (2) a guideline-based physiotherapy active control group intervention. Each intervention was delivered by a physiotherapist in a single, 1-hour, individualised treatment session.Primary outcome measuresThe primary outcomes were related to feasibility: recruitment, retention and treatment adherence of participants, feasibility and blinding of outcome assessments, fidelity of treatment delivery, credibility of, and satisfaction with, treatment. Assessments were performed at baseline and at 1 week post-treatment.Secondary outcome measuresPain intensity, pain interference, pain catastrophising, sleep disturbance, resilience, global rating of change, depression and quality of life. Statistical analyses were conducted blind to group allocation.ResultsForty participants were recruited. Thirty-eight participants (95%) completed the 1-week post-treatment assessment. Most primary outcomes surpassed the a priori thresholds for feasibility. Several findings have important implications for designing a full trial. Secondary analyses suggest clinical benefit of pain education over the control intervention, with larger decrease in pain intensity (mean difference=3.56 [95% CI 0.21 to 6.91]) and pain catastrophising (mean difference=6.16 [95% CI 0.59 to 11.72]) in the pain education group. Pain intensity would seem an appropriate outcome for a full clinical trial. One minor adverse event was reported.ConclusionWe conclude that a full RCT of pain education for back pain in Nepal is feasible and warranted.Trial registration numberNCT03387228; Results.

• Publisher: BMJ Publishing Group LTD,BMJ Publishing Group
• Subject: Adaptation / Adult / Back pain / Clinical medicine / Clinical trials / Culture / Curricula / Evidence Based Practice / Evidence-based medicine / Exercise / Feasibility Studies / Humans / Low Back Pain - psychology / Low Back Pain - rehabilitation / Low Back Pain - therapy / Male / Middle Aged / Nepal - epidemiology / Patient Compliance - psychology / Patient Compliance - statistics & numerical data / Patient Education as Topic / Patient Outcome Assessment / Patients / Physical Therapy Modalities