Pain education for patients with non-specific low back pain in Nepal: protocol of a feasibility randomised clinical trial (PEN-LBP Trial)
Open accessAbstract
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.
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Integrity signals
Registry
Cites
Statistics
Claims the paper makes
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
Feasibility was determined based on a priori criteria.
“Feasibility was to be determined based on a priori criteria.31”
A sample size of 40 (20 in each treatment arm) was estimated to be sufficient to adequately evaluate the feasibility of undertaking a full clinical trial.
“Based on guidance in the literature,47 the research team estimated that a sample size of 40 (20 in each treatment arm) would be sufficient to adequately evaluate the feasibility of undertaking a full clinical trial.31”
Sample size estimation was performed to achieve the primary feasibility outcomes goals, not to detect differences in the secondary treatment effects outcomes.
“Sample size estimation was performed to achieve the primary feasibility outcomes goals, as described in the protocol31 and registration documents, and not to detect differences in the secondary treatment effects outcomes.46”
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
The self-check needs the paper’s full text.
Cites
Vos, T., Abajobir, A. A., Abate, K. H., Abbafati, C., Abbas, K. M., Abd-Allah, F., Abdulkader, R. S., Abdulle, A. M., Abebo, T. A., Abera, S. F., et al. (2017) · The Lancet · doi:10.1016/s0140-6736(17)32154-2 · Cited by 13,220 · see citing works
Hoffmann, T. C., Glasziou, P. P., Boutron, I., Milne, R., Perera, R., Moher, D., Altman, D. G., Barbour, V., Macdonald, H., Johnston, M., et al. (2014) · BMJ · doi:10.1136/bmj.g1687 · Cited by 10,548 · see citing works
SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials
Chan, A.-W., Tetzlaff, J. M., Gotzsche, P. C., Altman, D. G., Mann, H., Berlin, J. A., Dickersin, K., Hrobjartsson, A., Schulz, K. F., Parulekar, W. R., et al. (2013) · BMJ · doi:10.1136/bmj.e7586 · Cited by 6,251 · see citing works
Farrar, J. T., Young, J. P., LaMoreaux, L., Werth, J. L., & Poole, M. R. (2001) · Pain · doi:10.1016/s0304-3959(01)00349-9 · Cited by 5,808 · see citing works
Core outcome measures for chronic pain clinical trials: IMMPACT recommendations
Dworkin, R. H., Turk, D. C., Farrar, J. T., Haythornthwaite, J. A., Jensen, M. P., Katz, N. P., Kerns, R. D., Stucki, G., Allen, R. R., Bellamy, N., et al. (2005) · Pain · doi:10.1016/j.pain.2004.09.012 · Cited by 3,732 · see citing works
Self-citationCONSORT 2010 statement: extension to randomised pilot and feasibility trials.
Eldridge, S. M., Chan, C. L., Campbell, M. J., Bond, C. M., Hopewell, S., Thabane, L., & Lancaster, G. A. (2016) · BMJ · doi:10.1136/bmj.i5239 · Cited by 3,404 · see citing works
Qaseem, A., Wilt, T. J., McLean, R. M., Forciea, M. A., & for the Clinical Guidelines Committee of the American College of Physicians* (2017) · Annals of Internal Medicine · doi:10.7326/m16-2367 · Cited by 3,234 · see citing works
CONSORT 2010 statement: extension to randomised pilot and feasibility trials
on behalf of the PAFS consensus group, Eldridge, S. M., Chan, C. L., Campbell, M. J., Bond, C. M., Hopewell, S., Thabane, L., & Lancaster, G. A. (2016) · Pilot and Feasibility Studies · doi:10.1186/s40814-016-0105-8 · Cited by 2,843 · see citing works
Balagué, F., Mannion, A. F., Pellisé, F., & Cedraschi, C. (2011) · The Lancet · doi:10.1016/s0140-6736(11)60610-7 · Cited by 1,861 · see citing works
Credibility of analogue therapy rationales
Borkovec, T. D., & Nau, S. D. (1972) · Journal of Behavior Therapy and Experimental Psychiatry · doi:10.1016/0005-7916(72)90045-6 · Cited by 1,553 · see citing works
Koes, B. W., van Tulder, M. W., Lin, C. C., Macedo, L. G., McAuley, J. H., & Maher, C. G. (2010) · European Spine Journal · doi:10.1007/s00586-010-1502-y · Cited by 1,301 · see citing works
Billingham, S. A., Whitehead, A. L., & Julious, S. A. (2013) · BMC Medical Research Methodology · doi:10.1186/1471-2288-13-104 · Cited by 962 · see citing works
Fifteen Years of Explaining Pain: The Past, Present, and Future
Moseley, G. L., & Butler, D. S. (2015) · The Journal of Pain · doi:10.1016/j.jpain.2015.05.005 · Cited by 856 · see citing works
Self-citationA Randomized Controlled Trial of Intensive Neurophysiology Education in Chronic Low Back Pain
Moseley, G. L., Nicholas, M. K., & Hodges, P. W. (2004) · The Clinical Journal of Pain · doi:10.1097/00002508-200409000-00007 · Cited by 537 · see citing works
Self-citationSpinal-Fusion Surgery — The Case for Restraint
Deyo, R. A., Nachemson, A., & Mirza, S. K. (2004) · New England Journal of Medicine · doi:10.1056/nejmsb031771 · Cited by 520 · see citing works
Motor control exercise for chronic non-specific low-back pain
Saragiotto, B. T., Maher, C. G., Yamato, T. P., Costa, L. O., Menezes Costa, L. C., Ostelo, R. W., & Macedo, L. G. (2016) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd012004 · Cited by 433 · see citing works
Moseley, G. L. (2003) · European Journal of Pain · doi:10.1016/s1090-3801(03)00063-6 · Cited by 402 · see citing works
Self-citationLow back pain and sciatica: summary of NICE guidance
Bernstein, I. A., Malik, Q., Carville, S., & Ward, S. (2017) · BMJ · doi:10.1136/bmj.i6748 · Cited by 399 · see citing works
Core outcome-domains for clinical trials in non-specific low back pain
Chiarotto, A., Deyo, R. A., Terwee, C. B., Boers, M., Buchbinder, R., Corbin, T. P., Costa, L. O. P., Foster, N. E., Grotle, M., Koes, B. W., et al. (2015) · European Spine Journal · doi:10.1007/s00586-015-3892-3 · Cited by 374 · see citing works
Low Back Pain in Australian Adults: The Economic Burden
Walker, B. F., Müller, R., & Grant, W. D. (2003) · Asia Pacific Journal of Public Health · doi:10.1177/101053950301500202 · Cited by 353 · see citing works
Diagnostic triage for low back pain: a practical approach for primary care
Bardin, L., King, P., & Maher, C. G. (2017) · The Medical Journal of Australia · doi:10.5694/mja16.00828 · Cited by 330 · see citing works
Plain Language: A Strategic Response to the Health Literacy Challenge
Stableford, S., & Mettger, W. (2007) · Journal of Public Health Policy · doi:10.1057/palgrave.jphp.3200102 · Cited by 242 · see citing works
Questions asked and answered in pilot and feasibility randomized controlled trials
Shanyinde, M., Pickering, R. M., & Weatherall, M. (2011) · BMC Medical Research Methodology · doi:10.1186/1471-2288-11-117 · Cited by 229 · see citing works
Saragiotto, B. T., Machado, G. C., Ferreira, M. L., Pinheiro, M. B., Shaheed, C. A., & Maher, C. G. (2016) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd012230 · Cited by 222 · see citing works
Trial of pregabalin for acute and chronic sciatica
Mathieson, S., Maher, C. G., McLachlan, A. J., Latimer, J., Koes, B. W., Hancock, M. J., Harris, I., Day, R. O., Billot, L., Pik, J., et al. (2017) · New England Journal of Medicine · doi:10.1056/nejmoa1614292 · Cited by 219 · see citing works
Hong, J., Reed, C., Novick, D., & Happich, M. (2013) · Spine · doi:10.1097/brs.0b013e318276450f · Cited by 210 · see citing works
Abbott, J. H. (2014) · Journal of Orthopaedic & Sports Physical Therapy · doi:10.2519/jospt.2014.0110 · Cited by 204 · see citing works
Self-citationNon-steroidal anti-inflammatory drugs for spinal pain: a systematic review and meta-analysis
Machado, G. C., Maher, C. G., Ferreira, P. H., Day, R. O., Pinheiro, M. B., & Ferreira, M. L. (2017) · Annals of the Rheumatic Diseases · doi:10.1136/annrheumdis-2016-210597 · Cited by 199 · see citing works
O'Connell, N. E., Cook, C. E., Wand, B. M., & Ward, S. P. (2016) · Best Practice & Research Clinical Rheumatology · doi:10.1016/j.berh.2017.05.001 · Cited by 193 · see citing works
Clarke, C., Ryan, C. G., & Martin, D. (2011) · Manual Therapy · doi:10.1016/j.math.2011.05.003 · Cited by 187 · see citing works
Primary care management of non-specific low back pain: key messages from recent clinical guidelines
Almeida, M., Saragiotto, B., Richards, B., & Maher, C. G. (2018) · Medical Journal of Australia · doi:10.5694/mja17.01152 · Cited by 174 · see citing works
Motor Control Exercise for Nonspecific Low Back Pain
Saragiotto, B. T., Maher, C. G., Yamato, T. P., Costa, L. O. P., Costa, L. C. M., Ostelo, R., & Macedo, L. G. (2016) · Spine · doi:10.1097/brs.0000000000001645 · Cited by 174 · see citing works
Efficacy and tolerability of muscle relaxants for low back pain: Systematic review and meta‐analysis
Shaheed, C. A., Maher, C. G., Williams, K. A., & McLachlan, A. J. (2016) · European Journal of Pain · doi:10.1002/ejp.907 · Cited by 135 · see citing works
Evidence-informed management of chronic low back pain with cognitive behavioral therapy
Gatchel, R. J., & Rollings, K. H. (2008) · The Spine Journal · doi:10.1016/j.spinee.2007.10.007 · Cited by 125 · see citing works
The utility and validity of pain intensity rating scales for use in developing countries
Pathak, A., Sharma, S., & Jensen, M. P. (2018) · PAIN Reports · doi:10.1097/pr9.0000000000000672 · Cited by 115 · see citing works
Self-citationTrends, Complications, and Costs for Hospital Admission and Surgery for Lumbar Spinal Stenosis
Machado, G. C., Maher, C. G., Ferreira, P. H., Harris, I. A., Deyo, R. A., McKay, D., Li, Q., & Ferreira, M. L. (2017) · Spine · doi:10.1097/brs.0000000000002207 · Cited by 112 · see citing works
Reassurance: Help or hinder in the treatment of pain
Linton, S. J., McCracken, L. M., & Vlaeyen, J. W. S. (2007) · Pain · doi:10.1016/j.pain.2007.10.002 · Cited by 97 · see citing works
Cherkin, D. C., Anderson, M. L., Sherman, K. J., Balderson, B. H. K., Cook, A. J., Hansen, K. E., & Turner, J. A. (2017) · JAMA · doi:10.1001/jama.2016.17814 · Cited by 77 · see citing works
Motor control exercise for acute non-specific low back pain
Macedo, L. G., Saragiotto, B. T., Yamato, T. P., Costa, L. O. P., Costa, L. C. M., Ostelo, R., & Maher, C. G. (2016) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd012085 · Cited by 75 · see citing works
Fritsch, C. G., Ferreira, M. L., Maher, C. G., et al. (2016) · European Spine Journal · doi:10.1007/s00586-016-4668-0 · Cited by 68 · see citing works
NSAIDs for Chronic Low Back Pain
Enthoven, W. T. M., Roelofs, P. D. D. M., & Koes, B. W. (2017) · JAMA · doi:10.1001/jama.2017.4571 · Cited by 63 · see citing works
Sharma, S., Palanchoke, J., Reed, D., & Haxby Abbott, J. (2017) · Health and Quality of Life Outcomes · doi:10.1186/s12955-017-0812-8 · Cited by 59 · see citing works
Self-citationDworkin, R. H., Jensen, M. P., Gould, E. M., Jones, B. A., Xiang, Q., Galer, B. S., & Gammaitoni, A. R. (2010) · Journal of Pain · doi:10.1016/j.jpain.2010.07.009 · Cited by 56 · see citing works
Self-citationReassurance for patients with non-specific conditions – a user's guide
Traeger, A. C., O’Hagan, E. T., Cashin, A. G., & McAuley, J. H. (2017) · Brazilian Journal of Physical Therapy · doi:10.1016/j.bjpt.2016.12.007 · Cited by 50 · see citing works
Crane, H. M., Rompaey, S. E. V., Dillingham, P. W., Herman, E., Diehr, P. H., & Kitahata, M. M. (2006) · AIDS Patient Care and STDs · doi:10.1089/apc.2006.20.161 · Cited by 49 · see citing works
Sharma, S., Pathak, A., Abbott, J. H., & Jensen, M. P. (2018) · Health and Quality of Life Outcomes · doi:10.1186/s12955-018-0884-0 · Cited by 45 · see citing works
Self-citationGeraghty, A. W. A., Stanford, R., Little, P. S., Roberts, L. C., Foster, N. E., Hill, J. C., Hay, E. M., Stuart, B. L., Turner, D., & Yardley, L. (2015) · BMJ Open · doi:10.1136/bmjopen-2015-009524 · Cited by 42 · see citing works
Sharma, S., Palanchoke, J., & Abbott, J. H. (2018) · Journal of Orthopaedic and Sports Physical Therapy · doi:10.2519/jospt.2018.7925 · Cited by 42 · see citing works
Self-citationSurgery or physical activity in the management of sciatica: a systematic review and meta-analysis
Fernandez, M., Ferreira, M. L., Refshauge, K. M., Hartvigsen, J., Silva, I. R. C., Maher, C. G., Koes, B. W., & Ferreira, P. H. (2015) · European Spine Journal · doi:10.1007/s00586-015-4148-y · Cited by 38 · see citing works
Sharma, S., Pathak, A., & Jensen, M. P. (2016) · Journal of Pain Research · doi:10.2147/jpr.s119212 · Cited by 33 · see citing works
Self-citationAn orthopedic ethnography in Rural Nepal
Anderson, R. (1984) · Medical Anthropology · doi:10.1080/01459740.1984.9965888 · Cited by 30 · see citing works
Bajracharya, S., Singh, M., Singh, G., & Shrestha, B. (2007) · Indian Journal of Orthopaedics · doi:10.4103/0019-5413.36988 · Cited by 28 · cited 2× · see citing works
“The primary objectives of the study are related to feasibility of an RCT, specifically: (1) willingness to participate in an RCT, (2) feasibility of assessor blinding, (3) eligibility and recruitment rates, (4) acceptability of screening procedures and random allocation, (5) possible contamination between the groups,…”
BackgroundThe TIDieR Checklist Will Benefit the Physical Therapy Profession
Yamato, T., Maher, C., Saragiotto, B., Moseley, A., Hoffmann, T., Elkins, M., & Abbott, J. H. (2016) · Journal of Orthopaedic & Sports Physical Therapy · doi:10.2519/jospt.2016.0108 · Cited by 27 · see citing works
Self-citationChronic pain and cost: an epidemiological study in the communities of Sunsari district of Nepal.
Bhattarai, B., Pokhrel, P. K., Tripathi, M., Rahman, T. R., Baral, D., Pande, R., & Bhattachaya, A. (2007) · PubMed · Cited by 26 · see citing works
Pinheiro, M. B., Ho, K. K., Ferreira, M. L., Refshauge, K. M., Grunstein, R. R., Hopper, J. L., Maher, C. G., Koes, B. W., Ordoñana, J. R., & Ferreira, P. H. (2016) · Twin Research and Human Genetics · doi:10.1017/thg.2016.67 · Cited by 25 · see citing works
Sharma, S., Thibault, P., Abbott, J. H., & Jensen, M. (2018) · Journal of Pain Research · doi:10.2147/jpr.s153061 · Cited by 23 · see citing works
Self-citationMengoni, S. E., Gates, B., Parkes, G., Wellsted, D. M., Barton, G., RING, H. A., Khoo, M. E., Monji-Patel, D., Friedli, K., Zia, A., et al. (2016) · BMJ Open · doi:10.1136/bmjopen-2016-012993 · Cited by 17 · see citing works
Hurley, J. A., O’Keeffe, M., O’Sullivan, P., Ryan, C. G., McCreesh, K. M., & O’Sullivan, K. (2016) · Manual Therapy · doi:10.1016/j.math.2016.02.009 · Cited by 12 · see citing works
Sharma, S., Pathak, A., Maharjan, R., Abbott, J. H., Correia, H., & Jensen, M. (2018) · Journal of Pain · doi:10.1016/j.jpain.2017.12.152 · Cited by 10 · see citing works
Self-citation
Flagged first, then by citations
Research works printed but not linked: 4
- [17]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 27213267 · DOI
- [33]Chen WH, Revicki DA, Amtmann D, et al Development and Analysis of PROMIS Pain Intensity Scale. Quality of Life Research 2012; 20: 18.
- [44]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 25799308 · DOI
- [51]National Institute for Health and Care Excellence. Low back pain and sciatica in over 16s: assessment and management. 2016 https://www.nice.org.uk/guidance/ng59. 27929617
Cited by
Sorted by citations
Sharma, S., Jensen, M. P., Moseley, G. L., & Abbott, J. H. (2019) · BMJ Open · doi:10.1136/bmjopen-2018-026874 · Cited by 61 · see citing works
Self-citationPulling, B. W., Braithwaite, F. A., Moseley, G. L., Jensen, M. P., Burke, A. L. J., Collins, K. L., Hull, M. J., Jones, H. G., Cyna, A. M., Ferencz, N., et al. (2022) · International Journal of Clinical and Experimental Hypnosis · doi:10.1080/00207144.2022.2105147 · Cited by 8 · see citing works
Self-citation
- Authors
- Sharma, S., Jensen, M. P., Moseley, G. L., & Abbott, J. H.
- Affiliations
- Kathmandu University (NP)
- University of Washington (US)
- University of South Australia (AU)
- University of Otago (NZ)
- Corresponding author
- Sharma, Saurab
- Venue
- BMJ Open
- Publisher
- BMJ
- Published
- 2018-08
- Volume
- 8
- Issue
- 8
- Pages
- e022423
- ISSN
- 2044-6055 (ISSN-L)
- PMC
- PMC6089285
- OpenAlex
- W2886309526
- Cited by
- 33
- References
- 59
- Citations by year
- 2026: 2 · 2025: 7 · 2024: 7 · 2023: 3 · 2022: 3 · 2021: 3 · 2020: 2 · 2019: 5 · 2018: 1
- FWCI
- 1.76
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- cc-by
- Locations
- BMJ Open (publishedVersion, cc-by)
- Europe PMC (PubMed Central) (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- UniSA Research Outputs Repository (University of South Australia) (acceptedVersion, other-oa)
- HighWire Press Open Archive (acceptedVersion)
- UNSWorks (University of New South Wales, Sydney, Australia) (submittedVersion, cc-by-nc-nd)
- Adelaide Research & Scholarship (AR&S) (University of Adelaide) (submittedVersion, cc-by)
- Funders
- University of Otago
- International Olympic Committee
- Topics
- Health Sciences › Medicine › Pharmacology › Musculoskeletal pain and rehabilitation
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Pregnancy-related medical research
- Health Sciences › Health Professions › General Health Professions › Health Policy Implementation Science
- Keywords
- non-specific low back pain, pain education, physiotherapy, feasibility, treatment acceptability, intervention adherence, trial blinding
- MeSH terms
- Adult, Clinical Protocols, Feasibility Studies, Female, Humans, Male, Nepal, Patient Education as Topic, Low Back Pain, Physical Therapy Modalities
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
