Pain education for patients with non-specific low back pain in Nepal: protocol of a feasibility randomised clinical trial (PEN-LBP Trial)

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

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.

Conflict of interest statement

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.

© Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY. Published by BMJ.

References

    1. Balagué F, Mannion AF, Pellisé F, et al. . Non-specific low back pain. Lancet 2012;379:482–91. 10.1016/S0140-6736(11)60610-7
    1. GBD 2016 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet 2017;390:1211–59. 10.1016/S0140-6736(17)32154-2
    1. Walker BF, Muller R, Grant WD. Low back pain in Australian adults: the economic burden. Asia Pac J Public Health 2003;15:79–87. 10.1177/101053950301500202
    1. Hong J, Reed C, Novick D, et al. . Costs associated with treatment of chronic low back pain: an analysis of the UK General Practice Research Database. Spine 2013;38:75–82. 10.1097/BRS.0b013e318276450f
    1. Machado GC, Maher CG, Ferreira PH, et al. . Trends, Complications, and Costs for Hospital Admission and Surgery for Lumbar Spinal Stenosis. Spine 2017;42:1737–43. 10.1097/BRS.0000000000002207
    1. Bhattarai B, Pokhrel PK, Tripathi M, et al. . Chronic pain and cost: an epidemiological study in the communities of Sunsari district of Nepal. Nepal Med Coll J 2007;9:6–11.
    1. Anderson RT. An orthopedic ethnography in rural Nepal. Med Anthropol 1984;8:46–59. 10.1080/01459740.1984.9965888
    1. Bajracharya S, Singh M, Singh GK, et al. . Clinico-epidemiological study of spinal injuries in a predominantly rural population of eastern Nepal: A 10 years' analysis. Indian J Orthop 2007;41:286–9. 10.4103/0019-5413.36988
    1. Deyo RA, Nachemson A, Mirza SK. Spinal-fusion surgery - the case for restraint. N Engl J Med 2004;350:722–6. 10.1056/NEJMsb031771
    1. Fritsch CG, Ferreira ML, Maher CG, et al. . The clinical course of pain and disability following surgery for spinal stenosis: a systematic review and meta-analysis of cohort studies. Eur Spine J 2017;26:324–35. 10.1007/s00586-016-4668-0
    1. Fernandez M, Ferreira ML, Refshauge KM, et al. . Surgery or physical activity in the management of sciatica: a systematic review and meta-analysis. Eur Spine J 2016;25:3495–512. 10.1007/s00586-015-4148-y
    1. Machado GC, Maher CG, Ferreira PH, et al. . Non-steroidal anti-inflammatory drugs for spinal pain: a systematic review and meta-analysis. Ann Rheum Dis 2017;76:1269–78. 10.1136/annrheumdis-2016-210597
    1. Enthoven WTM, Roelofs PD, Koes BW. NSAIDs for Chronic Low Back Pain. JAMA 2017;317:2327–8. 10.1001/jama.2017.4571
    1. Saragiotto BT, Machado GC, Ferreira ML, et al. . Paracetamol for low back pain. Cochrane Database Syst Rev 2016;6:CD012230.
    1. Mathieson S, Maher CG, McLachlan AJ, et al. . Trial of Pregabalin for Acute and Chronic Sciatica. N Engl J Med 2017;376:1111–20. 10.1056/NEJMoa1614292
    1. Abdel Shaheed C, Maher CG, Williams KA, et al. . Efficacy and tolerability of muscle relaxants for low back pain: Systematic review and meta-analysis. Eur J Pain 2017;21:228–37. 10.1002/ejp.907
    1. Abdel Shaheed C, Maher CG, Williams KA, et al. . Efficacy, Tolerability, and Dose-Dependent Effects of Opioid Analgesics for Low Back Pain: A Systematic Review and Meta-analysis. JAMA Intern Med 2016;176:958–68. 10.1001/jamainternmed.2016.1251
    1. Saragiotto BT, Maher CG, Yamato TP, et al. . Motor Control Exercise for Nonspecific Low Back Pain: A Cochrane Review. Spine 2016;41:1284–95. 10.1097/BRS.0000000000001645
    1. Macedo LG, Saragiotto BT, Yamato TP, et al. . Motor control exercise for acute non-specific low back pain. Cochrane Database Syst Rev 2016;2:CD012085 10.1002/14651858.CD012085
    1. Saragiotto BT, Maher CG, Yamato TP, et al. . Motor control exercise for chronic non-specific low-back pain. Cochrane Database Syst Rev 2016;1:CD012004.
    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;317:642–4. 10.1001/jama.2016.17814
    1. Gatchel RJ, Rollings KH. Evidence-informed management of chronic low back pain with cognitive behavioral therapy. Spine J 2008;8:40–4. 10.1016/j.spinee.2007.10.007
    1. Qaseem A, Wilt TJ, McLean RM, et al. . Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med 2017;166:514–30. 10.7326/M16-2367
    1. Van Wambeke P, Desomer A, Ailiet L, et al. . Low back pain and radicular pain: assessment and management. KCE Report 2017:287.
    1. Almeida M, Saragiotto B, Richards B, et al. . Primary care management of non-specific low back pain: key messages from recent clinical guidelines. Med J Aust 2018;208:272–5. 10.5694/mja17.01152
    1. Hurley J, O’Keeffe M, O’Sullivan P, et al. . Effect of education on non-specific neck and low back pain: A meta-analysis of randomized controlled trials. Man Ther 2016;23:e1–e2. 10.1016/j.math.2016.02.009
    1. Moseley GL. Evidence for a direct relationship between cognitive and physical change during an education intervention in people with chronic low back pain. Eur J Pain 2004;8:39–45. 10.1016/S1090-3801(03)00063-6
    1. Moseley GL, Nicholas MK, Hodges PW. A randomized controlled trial of intensive neurophysiology education in chronic low back pain. Clin J Pain 2004;20:324–30. 10.1097/00002508-200409000-00007
    1. Moseley G, Butler D. Explain pain supercharged. Adelaide, Australia: Noigroup publications, 2017.
    1. Sharma S, Pathak A, Jensen MP. Words that describe chronic musculoskeletal pain: implications for assessing pain quality across cultures. J Pain Res 2016;9:1057–66. 10.2147/JPR.S119212
    1. Eldridge SM, Chan CL, Campbell MJ, et al. . CONSORT 2010 statement: extension to randomised pilot and feasibility trials. BMJ 2016;355:i5239.
    1. Chan AW, Tetzlaff JM, Gøtzsche PC, et al. . SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ 2013;346:e7586 10.1136/bmj.e7586
    1. Chen WH, Revicki DA, Amtmann D, et al. . Development and Analysis of PROMIS Pain Intensity Scale. Quality of Life Research 2012;20:18.
    1. Bardin LD, King P, Maher CG. Diagnostic triage for low back pain: a practical approach for primary care. Med J Aust 2017;206:268–73. 10.5694/mja16.00828
    1. Billingham SA, 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;13:104 10.1186/1471-2288-13-104
    1. Mengoni SE, Gates B, Parkes G, et al. . Wordless intervention for people with epilepsy and learning disabilities (WIELD): a randomised controlled feasibility trial. BMJ Open 2016;6:e012993 10.1136/bmjopen-2016-012993
    1. Central Bureau of Statistics, Nepal. National Planning Commission Secretariat National Population and Housing Census 2011 (National Report). Kathmandu: Government of Nepal, 2012.
    1. Yamato T, Maher C, Saragiotto B, et al. . The TIDieR Checklist Will Benefit the Physical Therapy Profession. J Orthop Sports Phys Ther 2016;46:402–4. 10.2519/jospt.2016.0108
    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. Butler DS, Moseley GL. Explain Pain 2nd Edn: Noigroup Publications, 2013.
    1. Moseley GL, Butler DSB. Explain Pain Handbook: Protectometer, 2015.
    1. Moseley GL, Butler DS. Fifteen Years of Explaining Pain: The Past, Present, and Future. J Pain 2015;16:807–13. 10.1016/j.jpain.2015.05.005
    1. Clarke CL, Ryan CG, Martin DJ. Pain neurophysiology education for the management of individuals with chronic low back pain: systematic review and meta-analysis. Man Ther 2011;16:544–9. 10.1016/j.math.2011.05.003
    1. Traeger AC, Hübscher M, Henschke N, et al. . Effect of Primary Care-Based Education on Reassurance in Patients With Acute Low Back Pain: Systematic Review and Meta-analysis. JAMA Intern Med 2015;175:733–43. 10.1001/jamainternmed.2015.0217
    1. Linton SJ, McCracken LM, Vlaeyen JW. Reassurance: help or hinder in the treatment of pain. Pain 2008;134(1-2):5–8. 10.1016/j.pain.2007.10.002
    1. Koes BW, van Tulder M, Lin CW, et al. . An updated overview of clinical guidelines for the management of non-specific low back pain in primary care. Eur Spine J 2010;19:2075–94. 10.1007/s00586-010-1502-y
    1. Traeger AC, O’Hagan ET, Cashin A, et al. . Reassurance for patients with non-specific conditions - a user’s guide. Braz J Phys Ther 2017;21:1–6. 10.1016/j.bjpt.2016.12.007
    1. Stableford S, Mettger W. Plain language: a strategic response to the health literacy challenge. J Public Health Policy 2007;28:71–93. 10.1057/palgrave.jphp.3200102
    1. Bernstein IA, Malik Q, Carville S, et al. . Low back pain and sciatica: summary of NICE guidance. BMJ 2017;356:i6748 10.1136/bmj.i6748
    1. Toward Optimized Practice (TOP) Low Back Pain Working Group. Evidence-informed primary care management of low back pain: clinical practice guideline. 2015. .
    1. National Institute for Health and Care Excellence. Low back pain and sciatica in over 16s: assessment and management. 2016. .
    1. O’Connell NE, Cook CE, Wand BM, et al. . Clinical guidelines for low back pain: A critical review of consensus and inconsistencies across three major guidelines. Best Pract Res Clin Rheumatol 2016;30 10.1016/j.berh.2017.05.001
    1. Chiarotto A, Deyo RA, Terwee CB, et al. . Core outcome domains for clinical trials in non-specific low back pain. Eur Spine J 2015;24:1127–42. 10.1007/s00586-015-3892-3
    1. Sharma S, Pathak A, Maharjan R, et al. . Psychometric properties of nepali versions of PROMIS short from measures of pain intensity, pain interference, pain behaviour, depressions, and sleep disturbance. The Journal of Pain 2018;19:S59 10.1016/j.jpain.2017.12.152
    1. Sharma S, Thibault P, Abbott JH, et al. . Clinimetric properties of the Nepali version of the Pain Catastrophizing Scale in individuals with chronic pain. J Pain Res 2018;11:265–76. 10.2147/JPR.S153061
    1. Sharma S, Pathak A, Abbott JH, et al. . Measurement properties of the Nepali version of the Connor Davidson resilience scales in individuals with chronic pain. Health Qual Life Outcomes 2018;16:56 10.1186/s12955-018-0884-0
    1. Sharma S, Palanchoke J, Reed D, et al. . Translation, cross-cultural adaptation and psychometric properties of the Nepali versions of numerical pain rating scale and global rating of change. Health Qual Life Outcomes 2017;15:236 10.1186/s12955-017-0812-8
    1. Sharma S, Palanchoke J, Abbott JH. Cross-Cultural Adaptation and Validation of the Nepali Translation of the Patient-Specific Functional Scale. J Orthop Sports Phys Ther 2018. 1–23. 10.2519/jospt.2018.7925
    1. Geraghty AW, Stanford R, Little P, et al. . Using an internet intervention to support self-management of low back pain in primary care: protocol for a randomised controlled feasibility trial (SupportBack). BMJ Open 2015;5:e009524 10.1136/bmjopen-2015-009524
    1. Shanyinde M, Pickering RM, Weatherall M. Questions asked and answered in pilot and feasibility randomized controlled trials. BMC Med Res Methodol 2011;11:117 10.1186/1471-2288-11-117
    1. Abbott JH. The distinction between randomized clinical trials (RCTs) and preliminary feasibility and pilot studies: what they are and are not. J Orthop Sports Phys Ther 2014;44:555–8. 10.2519/jospt.2014.0110
    1. Pinheiro MB, Ho KK, Ferreira ML, et al. . Efficacy of a Sleep Quality Intervention in People With Low Back Pain: Protocol for a Feasibility Randomized Co-Twin Controlled Trial. Twin Res Hum Genet 2016;19:492–501. 10.1017/thg.2016.67
    1. Borkovec TD, Nau SD. Credibility of analogue therapy rationales. J Behav Ther Exp Psychiatry 1972;3 257–60. 10.1016/0005-7916(72)90045-6
    1. Pathak A, Sharma S, Jensen MP. The Utility and Validity of Pain Intensity Rating Scales for use in Developing Countries. Pain Reports. In Press 2018.
    1. Dworkin RH, Jensen MP, Gould E, et al. . Treatment satisfaction in osteoarthritis and chronic low back pain: the role of pain, physical and emotional functioning, sleep, and adverse events. J Pain 2011;12:416–24. 10.1016/j.jpain.2010.07.009
    1. Dworkin RH, Turk DC, Farrar JT, et al. . Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain 2005;113(1-2):9–19. 10.1016/j.pain.2004.09.012
    1. Farrar JT, Young JP, LaMoreaux L, et al. . Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain 2001;94:149–58. 10.1016/S0304-3959(01)00349-9
    1. Crane HM, Van Rompaey SE, Dillingham PW, et al. . A single-item measure of health-related quality-of-life for HIV-infected patients in routine clinical care. AIDS Patient Care STDS 2006;20:161–74. 10.1089/apc.2006.20.161

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