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  • Clinical and cost-effectiveness of an online-delivered group-based pain management programme in improving pain-related disability for people with persistent pain—protocol for a non-inferiority randomised controlled trial (iSelf-help trial)

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Health services research
Protocol
Clinical and cost-effectiveness of an online-delivered group-based pain management programme in improving pain-related disability for people with persistent pain—protocol for a non-inferiority randomised controlled trial (iSelf-help trial)
  1. Leigh Hale1,
  2. Hemakumar Devan2,
  3. Cheryl Davies3,
  4. Sarah Gerard Dean4,
  5. Anthony Dowell5,
  6. Rebecca Grainger6,
  7. Andrew R Gray7,
  8. Dagmar Hempel8,
  9. Tristram Ingham6,
  10. Bernadette Jones6,
  11. William Leung9,
  12. Jessica Mills10,
  13. Barbara Saipe8,
  14. Edward Shipton11,
  15. Meredith Perry2
  1. 1 Centre for Health, Activity and Rehabilitation Research (CHARR), School of Physiotherapy, Dunedin, New Zealand
  2. 2 Centre for Health, Activity and Rehabilitation Research (CHARR), School of Physiotherapy, Wellington, New Zealand
  3. 3 Tu Kotahi Māori Asthma and Research Trust, Wellington, New Zealand
  4. 4 College of Medicine and Health, University of Exeter Medical School, Exeter, UK
  5. 5 Department of Primary Health Care and General Practice, University of Otago, Wellington, New Zealand
  6. 6 Department of Medicine, University of Otago, Wellington, New Zealand
  7. 7 Biostatistics Unit, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand
  8. 8 Pain Management Service, Capital and Coast District Health Board (CCDHB), Wellington, New Zealand
  9. 9 Department of Public Health, University of Otago, Wellington, New Zealand
  10. 10 Burwood Pain Management Service, Canterbury District Health Board (CDHB), Christchurch, New Zealand
  11. 11 Department of Anaesthesia, University of Otago, Christchurch, New Zealand
  1. Correspondence to Professor Leigh Hale; leigh.hale{at}otago.ac.nz

Abstract

Introduction Persistent non-cancer pain affects one in five adults and is more common in Māori—the Indigenous population of New Zealand (NZ), adults over 65 years, and people living in areas of high deprivation. Despite the evidence supporting multidisciplinary pain management programmes (PMPs), access to PMPs is poor due to long waiting lists. Although online-delivered PMPs enhance access, none have been codesigned with patients or compared with group-based, in-person PMPs. This non-inferiority trial aims to evaluate the clinical and cost-effectiveness of a cocreated, culturally appropriate, online-delivered PMP (iSelf-help) compared with in-person PMP in reducing pain-related disability.

Methods and analysis Mixed-methods, using a modified participatory action research (PAR) framework, involving three phases. Phase I involved cocreation and cultural appropriateness of iSelf-help by PAR team members. Phase II: The proposed iSelf-help trial is a pragmatic, multicentred, assessor-blinded, two-arm, parallel group, non-inferiority randomised controlled trial. Adults (n=180, age ≥18 years) with persistent non-cancer pain eligible for a PMP will be recruited and block randomised (with equal probabilities) to intervention (iSelf-help) and control groups (in-person PMP). The iSelf-help participants will participate in two 60-minute video-conferencing sessions weekly for 12 weeks with access to cocreated resources via smartphone application and a password-protected website. The control participants will receive group-based, in-person delivered PMP. Primary outcome is pain-related disability assessed via modified Roland Morris Disability Questionnaire at 6 months post intervention. Secondary outcomes include anxiety, depression, stress, pain severity, quality of life, acceptance, self-efficacy, catastrophising and fear avoidance. Data will be collected at baseline, after the 12-week intervention, and at 3 and 6 months post intervention. We will conduct economic analyses and mixed-method process evaluations (Phase IIA).

Ethics and dissemination The Health and Disability Ethics Committee approved the study protocol (HDEC18/CEN/162). Phase III involves dissemination of findings guided by the PAR team as outcomes become apparent.

Trial registration number ACTRN 12619000771156.

  • pain management
  • clinical trials
  • musculoskeletal disorders
  • protocols & guidelines
http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjopen-2020-046376

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    Footnotes

    • Twitter @HemDevan, @drbeckyg, @docingham

    • Contributors LH, HD and MP were involved in the conception of the study. LH, HD, MP, AD, RG, ES, SGD, ARG, WL, BJ and TI contributed to the study design. HD and LH wrote the grant application with inputs from MP, AD, RG, ES, ARG, WL, BJ, TI and SGD. BJ and TI led the cultural adaptation component with inputs from CD. HD prepared the trial registration and application for ethical approval with inputs from LH and MP. DH, BS and JM contributed to design and intervention delivery. HD with inputs from SGD wrote the process-evaluation component. WL wrote the economic evaluation component. ARG wrote the statistical methods section. All authors reviewed and critiqued the manuscript and approved the final version.

    • Funding This work was supported by the Health Research Council of New Zealand 18/254. The funding body has not had any role in the study design or outputs from the study.

    • Competing interests None declared.

    • Patient consent for publication Not required.

    • Provenance and peer review Not commissioned; peer reviewed for ethical and funding approval prior to submission.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.