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Pain education for patients with non-specific low back pain in Nepal: protocol of a feasibility randomised clinical trial (PEN-LBP Trial)
  1. Saurab Sharma1,2,
  2. Mark P Jensen3,
  3. G Lorimer Moseley4,
  4. J Haxby Abbott2
  1. 1 Department of Physiotherapy, Kathmandu University School of Medical Sciences, Dhulikhel, Bagmati, Nepal
  2. 2 Centre for Musculoskeletal Outcomes Research, Dunedin School of Medicine, University of Otago, Dunedin, Otago, New Zealand
  3. 3 Department of Rehabilitation Medicine, University of Washington, Seattle, Washington, USA
  4. 4 School of Health Sciences, University of South Australia, Adelaide, South Australia, Australia
  1. Correspondence to Saurab Sharma; saurabsharma1{at}gmail.com

Abstract

Introduction Low back pain (LBP) is the leading cause of years lived with disability in Nepal and elsewhere. Management of LBP that is evidence-based, easily accessible, cost-effective and culturally appropriate is desirable. The primary aim of this feasibility study is to determine if it is feasible to conduct a full randomised clinical trial evaluating the effectiveness of pain education as an intervention for individuals with LBP in Nepal, relative to guideline-based physiotherapy treatment. The findings of the study will inform the planning of a full clinical trial and if any modifications are required to the protocol before undertaking a full trial.

Methods/analysis This protocol describes an assessor-blinded feasibility clinical trial investigating feasibility of the pain education intervention in patients with non-specific LBP in a physiotherapy hospital in Kathmandu, Nepal. Forty patients with LBP will be randomly allocated to either pain education or guideline-based physiotherapy treatment (control). Outcomes will be assessed at baseline and at a 1 week post-treatment. The primary outcomes are related to feasibility, including: (1) participant willingness to participate in a randomised clinical trial, (2) feasibility of assessor blinding, (3) eligibility and recruitment rates, (4) acceptability of screening procedures and random allocation, (5) possible contamination between the groups, (6) intervention credibility, (7) intervention adherence, (8) treatment satisfaction and (9) difficulty in understanding the interventions being provided.

Ethics/dissemination The protocol was approved by Nepal Health Research Council (NHRC; registration number: 422/2017) and University of Otago Human Ethics Committee for Health (registration number: H17/157). The results of the study will be presented at national and international conferences and published in a peer-reviewed journal.

Trial registration number NCT03387228; Pre-results.

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

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Footnotes

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  • Contributors SS, JHA and MPJ conceived the idea of the trial. Trial was designed by all authors. SS prepared the first draft of the protocol. Successive drafts were edited by JHA, MPJ and GLM. The final version of the protocol was approved by all the authors.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests SS is supported by University of Otago Doctoral Research Grant. GLM has received support from Pfizer, AIA Australia, Gallagher Bassett, Kaiser Permanente USA, Port Adelaide Football Club, Arsenal Football Club and the International Olympic Committee. GLM receives royalties for books on pain and rehabilitation, including the text on which the content for the proposed intervention was based. He also receives speaker fees for lectures on pain and rehabilitation. Other authors report no competing interests.

  • Patient consent Obtained.

  • Ethics approval The protocol was approved by Nepal Health Research Council (ref number 422/2017) and University of Otago Human Research Committee (Health) (ref number H17/157).

  • Provenance and peer review Not commissioned; externally peer reviewed.

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