Combined online interactive mindfulness and exercise programme (MOVE-Online) compared with a self-management guide for adults with chronic pain: protocol for a randomised controlled feasibility trial

Orla Deegan, Brona M Fullen, Maire-Brid Casey, Ricardo Segurado, Conor Hearty, Catherine M Doody, Orla Deegan, Brona M Fullen, Maire-Brid Casey, Ricardo Segurado, Conor Hearty, Catherine M Doody

Abstract

Introduction: Online pain management programmes (PMP) have growing evidence as effective interventions for individuals with chronic pain (CP). Mindfulness-based stress reduction (MBSR) is a psychological intervention proven to be effective in the management of CP. There is also a large body of evidence for the efficacy of exercise in the management of CP however, there are limited studies combining both these interventions and none to date delivering a combined intervention in the form of an online PMP. This study aims to explore the acceptability and feasibility of delivering a combined MBSR and exercise online PMP for adults with CP, and will examine the feasibility of conducting a randomised controlled trial of a combined MBSR and exercise online programme compared with an online self-management guide.

Methods and analysis: A parallel-group, feasibility randomised controlled trial (RCT) will be conducted among participants in Ireland, which will include an embedded qualitative study. Seventy-five participants will complete an online consent form and be individually randomised to one of two groups. Group A will participate in live online MBSR and supervised exercise sessions (2 hours MBSR, 1 hour exercise) once a week for 8 weeks. Group B will receive access to an 8-week online self-management guide, released biweekly and containing eight self-directed modules. Analyses of the feasibility study will be descriptive and will address the outcomes relating to the feasibility and acceptability of the interventions and procedures of the study including recruitment and eligibility, data collection methods, intervention adherence, engagement and attrition rates, intervention acceptability and participants' subjective perceptions of the programmes. Comparisons of clinical treatment effects, using validated patient-reported outcome measures will be explored descriptively to consider the viability of investigating a combined online MBSR and exercise intervention in a future fully powered RCT.

Ethics and dissemination: This study was approved by the Mater Misericordiae University Hospital Institutional Review Board (1/378/2124) and the University College Dublin Human Research Ethics Committee (LS-20-76-Deegan-Doody). Informed consent will be obtained from each participant prior to randomisation. The results of this feasibility study will be published in peer-reviewed academic journals and presented at national and international conferences.

Trial registration: NCT04899622.

Keywords: pain management; rehabilitation medicine; telemedicine.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Standard Protocol Items: Recommendations for Interventional Trials diagram. MOVE, Mindfulness Online and Virtual Exercise.
Figure 2
Figure 2
Adapted CONSORT diagram for pilot feasibility studies, illustrating participant progression through the study. CONSORT, Consolidated Standards of Reporting Trials.
Figure 3
Figure 3
Online self-management guide website page displaying the guides’ eight modules; What is CP, CP and nutrition, Sleep issues with CP, activity and exercise, pacing, using a pain diary, relaxation and mindfulness and course summary. CP, chronic pain.

References

    1. Breivik H, Collett B, Ventafridda V, et al. . Survey of chronic pain in Europe: prevalence, impact on daily life, and treatment. Eur J Pain 2006;10:287. 10.1016/j.ejpain.2005.06.009
    1. Tsang A, Von Korff M, Lee S, et al. . Common chronic pain conditions in developed and developing countries: gender and age differences and comorbidity with depression-anxiety disorders. J Pain 2008;9:883–91. 10.1016/j.jpain.2008.05.005
    1. International association for the study of pain and delegates of international pain Summit 2010: Declaration that access to pain management is a fundamental human right., 2021. Available:
    1. Murray CJL. The state of US health, 1990-2010. JAMA 2013;310:591. 10.1001/jama.2013.13805
    1. Scottish Intercollegiate guidelines network (sign) . Management of chronic pain Edinburgh: sign; 2013. (sign publication No. 136), 2013. Available:
    1. British Pain Society . Guidelines for Pain Management Programmes for Adults. London: British Pain Society, 2013.
    1. Hoffman BM, Papas RK, Chatkoff DK, et al. . Meta-Analysis of psychological interventions for chronic low back pain. Health Psychology 2007;26:1–9. 10.1037/0278-6133.26.1.1
    1. van Tulder MW, Ostelo R, Vlaeyen JWS, et al. . Behavioral treatment for chronic low back pain. Spine 2000;25:2688–99. 10.1097/00007632-200010150-00024
    1. Williams ACdeC, Fisher E, Hearn L, et al. . Psychological therapies for the management of chronic pain (excluding headache) in adults. Cochrane Database Syst Rev 2020;8:CD007407. 10.1002/14651858.CD007407.pub4
    1. Garg S, Garg D, Turin TC, et al. . Web-Based interventions for chronic back pain: a systematic review. J Med Internet Res 2016;18:e139. 10.2196/jmir.4932
    1. Macea DD, Gajos K, Daglia Calil YA, et al. . The efficacy of web-based cognitive behavioral interventions for chronic pain: a systematic review and meta-analysis. The Journal of Pain 2010;11:917–29. 10.1016/j.jpain.2010.06.005
    1. Mariano TY, Wan L, Edwards RR, et al. . Online teletherapy for chronic pain: a systematic review. J Telemed Telecare 2021;27:195–208. 10.1177/1357633X19871746
    1. Bender JL, Radhakrishnan A, Diorio C, et al. . Can pain be managed through the Internet? A systematic review of randomized controlled trials. Pain 2011;152:1740–50. 10.1016/j.pain.2011.02.012
    1. Herbert MS, Afari N, Liu L, et al. . Telehealth versus In-Person acceptance and commitment therapy for chronic pain: a randomized Noninferiority trial. The Journal of Pain 2017;18:200–11. 10.1016/j.jpain.2016.10.014
    1. Riva S, Camerini A-L, Allam A, et al. . Interactive sections of an Internet-based intervention increase Empowerment of chronic back pain patients: randomized controlled trial. J Med Internet Res 2014;16:e180. 10.2196/jmir.3474
    1. Merkes M. Mindfulness-based stress reduction for people with chronic diseases. Aust J Prim Health 2010;16:200. 10.1071/PY09063
    1. Cherkin DC, Anderson ML, Sherman KJ, et al. . Two-Year follow-up of a randomized clinical trial of Mindfulness-Based stress reduction vs cognitive behavioral therapy or usual care for chronic low back pain. JAMA 2017;317:642. 10.1001/jama.2016.17814
    1. Gotink RA, Chu P, Busschbach JJV, et al. . Standardised Mindfulness-Based interventions in healthcare: an overview of systematic reviews and meta-analyses of RCTs. PLOS ONE 2015;10:e0124344. 10.1371/journal.pone.0124344
    1. Turner JA, Anderson ML, Balderson BH, et al. . Mindfulness-based stress reduction and cognitive behavioral therapy for chronic low back pain: similar effects on mindfulness, catastrophizing, self-efficacy, and acceptance in a randomized controlled trial. Pain 2016;157:2434–44. 10.1097/j.pain.0000000000000635
    1. Eccleston C, Fisher E, Craig L. Psychological therapies (internet-delivered) for the management of chronic pain in adults. Cochrane Database Syst Rev 2014;2014. 10.1002/14651858.CD010152.pub2
    1. National Institute for Health and Care Excellence (NICE) . Chronic pain (primary and secondary) in over 16S: assessment of all chronic pain and management of chronic primary pain. NG193, 2021. Available: [Accessed 18 Jul 2021].
    1. Geneen LJ, Moore RA, Clarke C, et al. . Physical activity and exercise for chronic pain in adults: an overview of Cochrane reviews. Cochrane Database Syst Rev 2017;1:CD011279. 10.1002/14651858.CD011279.pub2
    1. Bidonde J, Busch AJ, Schachter CL, et al. . Mixed exercise training for adults with fibromyalgia. Cochrane Database Syst Rev 2019;5:CD013340. 10.1002/14651858.CD013340
    1. Eldridge S, Bond C, Campbell M, et al. . Defining feasibility and pilot studies in preparation for randomised controlled trials: using consensus methods and validation to develop a conceptual framework. Trials 2015;16. 10.1186/1745-6215-16-S2-O87
    1. Chan A-W, Tetzlaff JM, Altman DG, et al. . Spirit 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med 2013;158:200–7. 10.7326/0003-4819-158-3-201302050-00583
    1. Sim J, Lewis M. The size of a pilot study for a clinical trial should be calculated in relation to considerations of precision and efficiency. J Clin Epidemiol 2012;65:301–8. 10.1016/j.jclinepi.2011.07.011
    1. Lewis M, Bromley K, Sutton CJ, et al. . Determining sample size for progression criteria for pragmatic pilot RCTs: the hypothesis test strikes back! Pilot and Feasibility Studies 2021;7. 10.1186/s40814-021-00770-x
    1. Billingham SAM, Whitehead AL, Julious SA. An audit of sample sizes for pilot and feasibility trials being undertaken in the United Kingdom registered in the United Kingdom clinical research network database. BMC Med Res Methodol 2013;13. 10.1186/1471-2288-13-104
    1. Eldridge S, Chan C, Campbell M. Consort 2010 statement: extension to randomised pilot and feasibility trials. BMJ 2016;355:5239. 10.1136/bmj.i5239
    1. Hoffmann TC, Glasziou PP, Boutron I, et al. . Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ 2014;348:g1687. 10.1136/bmj.g1687
    1. Santorrelli SF, Meleo,-Meyer F, Koerbal L. Mindfulness-Based stress reduction (MBSR) authorized curriculum guide. centre for mindfulness in medicine, health care and society at University of Massachusetts medical school, 2017.
    1. Hayden J, van Tulder MW, Malmivaara A, et al. . Exercise therapy for treatment of non-specific low back pain. Cochrane Database Syst Rev 2005;35. 10.1002/14651858.CD000335.pub2
    1. Busch AJ, Webber SC, Richards RS, et al. . Resistance exercise training for fibromyalgia. Cochrane Database of Systematic Reviews 2013;28. 10.1002/14651858.CD010884
    1. Dworkin RH, Turk DC, Farrar JT, et al. . Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain 2005;113:9–19. 10.1016/j.pain.2004.09.012
    1. Casey M-B, Smart K, Segurado R, et al. . Exercise combined with acceptance and commitment therapy (exact) compared to a supervised exercise programme for adults with chronic pain: study protocol for a randomised controlled trial. Trials 2018;19:194. 10.1186/s13063-018-2543-5
    1. Keogh E, Rosser BA, Eccleston C. E-Health and chronic pain management: current status and developments. Pain 2010;151:18–21. 10.1016/j.pain.2010.07.014
    1. Lamb SE, Lall R, Hansen Z, et al. . A multicentred randomised controlled trial of a primary care-based cognitive behavioural programme for low back pain. The back skills training (best) trial. Health Technol Assess 2010;14:1-253, iii-iv. 10.3310/hta14410
    1. McCracken LM, Sato A, Wainwright D, et al. . A feasibility study of brief group-based acceptance and commitment therapy for chronic pain in general practice: recruitment, attendance, and patient views. Prim Health Care Res Dev 2014;15:312–23. 10.1017/S1463423613000273
    1. Bull FC, Al-Ansari SS, Biddle S, et al. . World Health organization 2020 guidelines on physical activity and sedentary behaviour. Br J Sports Med 2020;54:1451–62. 10.1136/bjsports-2020-102955
    1. Braun V, Clarke V. Using thematic analysis in psychology. Qual Res Psychol 2006;3:77–101. 10.1191/1478088706qp063oa
    1. Creswell J. Qualitative inquiry and research design. Thousand Oaks: Sage, 1998.
    1. Larsen DL, Attkisson CC, Hargreaves WA, et al. . Assessment of client/patient satisfaction: development of a general scale. Eval Program Plann 1979;2:197–207. 10.1016/0149-7189(79)90094-6
    1. Pelayo-Alvarez M, Perez-Hoyos S, Agra-Varela Y. Reliability and concurrent validity of the palliative outcome scale, the Rotterdam symptom checklist, and the brief pain inventory. J Palliat Med 2013;16:867–74. 10.1089/jpm.2012.0625
    1. Jerome A, Gross RT. Pain disability index: construct and discriminant validity. Arch Phys Med Rehabil 1991;72:920–2. 10.1016/0003-9993(91)90012-8
    1. Kamper SJ, Maher CG, Mackay G. Global rating of change scales: a review of strengths and weaknesses and considerations for design. J Man Manip Ther 2009;17:163–70. 10.1179/jmt.2009.17.3.163
    1. Kroenke K, Spitzer RL, Williams JBW. The PHQ-9. J Gen Intern Med 2001;16:606–13. 10.1046/j.1525-1497.2001.016009606.x
    1. LoMartire R, Äng BO, Gerdle B, et al. . Psychometric properties of short Form-36 health survey, EuroQol 5-dimensions, and hospital anxiety and depression scale in patients with chronic pain. Pain 2020;161:83–95. 10.1097/j.pain.0000000000001700
    1. Spitzer RL, Kroenke K, Williams JBW, et al. . A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med 2006;166:1092. 10.1001/archinte.166.10.1092
    1. Chiarotto A, Vanti C, Cedraschi C, et al. . Responsiveness and minimal important change of the pain self-efficacy questionnaire and short forms in patients with chronic low back pain. J Pain 2016;17:707–18. 10.1016/j.jpain.2016.02.012
    1. Sullivan MJL, Bishop SR, Pivik J. The pain Catastrophizing scale: development and validation. Psychol Assess 1995;7:524–32. 10.1037/1040-3590.7.4.524
    1. Williamson E. Fear avoidance beliefs questionnaire (FABQ). Australian Journal of Physiotherapy 2006;52:149. 10.1016/S0004-9514(06)70052-6

Source: PubMed

Sponsors et collaborateurs

Les conditions médicales

Interventions en matière de drogue

3
S'abonner