Protocol for a pragmatic randomized controlled trial (the Exercise guideline Promotion and Implementation in Chronic SCI [EPIC-SCI] Trial).
To test if home-/community-based exercise, prescribed according to the international SCI exercise guidelines, significantly reduces chronic bodily pain in adults with SCI.
To investigate: (1) the effects of exercise on musculoskeletal and neuropathic chronic pain; (2) if reduced inflammation and increased descending inhibitory control are viable pathways by which exercise reduces pain; (3) the effects of chronic pain reductions on subjective well-being; and (4) efficiency of a home-/community-based exercise intervention.
Exercise in home-/community-based settings; assessments in university-based laboratories in British Columbia, Canada.
Eighty-four adults with chronic SCI, reporting chronic musculoskeletal or neuropathic pain, and not meeting the current SCI exercise guidelines, will be recruited and randomized to a 6-month Exercise or Wait-List Control condition. Exercise will occur in home/community settings and will be supported through behavioral counseling. All measures will be taken at baseline, 3-months and 6-months. Analyses will consist of linear mixed effect models, multiple regression analyses and a cost–utility analysis. The economic evaluation will examine the incremental costs and health benefits generated by the intervention compared with usual care.
Ethics and dissemination
The University of British Columbia Clinical Research Ethics Board approved the protocol (#H19–01650). Using an integrated knowledge translation approach, stakeholders will be engaged throughout the trial and will co-create and disseminate evidence-based recommendations and messages regarding the use of exercise to manage SCI chronic pain.
ClinicalTrials.gov identifier NCT04160858.
Subscribe to Journal
Get full journal access for 1 year
only $21.58 per issue
All prices are NET prices.
VAT will be added later in the checkout.
Tax calculation will be finalised during checkout.
Rent or Buy article
Get time limited or full article access on ReadCube.
All prices are NET prices.
Data sharing not applicable to this article as no datasets were generated or analyzed. De-identified data will be made available upon publication of the datasets, using an open-source web application that supports DOI (e.g., Open Science Framework, Dataverse).
van Gorp S, Kessels AG, Joosten EA, van Kleef M, Patijn J. Pain prevalence and its determinants after spinal cord injury: a systematic review. Eur J pain (Lond, Engl). 2015;19:5–14.
Finnerup NB, Baastrup C. Spinal cord injury pain: mechanisms and management. Curr pain headache Rep. 2012;16:207–16.
Mann R, Schaefer C, Sadosky A, Bergstrom F, Baik R, Parsons B, et al. Burden of spinal cord injuryrelated neuropathic pain in the United States: retrospective chart review and cross-sectional survey. Spinal Cord. 2013;51:564–70.
Tran J, Dorstyn DS, Burke AL. Psychosocial aspects of spinal cord injury pain: a meta-analysis. Spinal Cord. 2016;54:640–8.
Siddall PJ, McClelland JM, Rutkowski SB, Cousins MJ. A longitudinal study of the prevalence and characteristics of pain in the first 5 years following spinal cord injury. Pain. 2003;103:249–57.
Guy SD, Mehta S, Casalino A, Côté I, Kras-Dupuis A, Moulin DE et al. The CanPain SCI clinical practice guidelines for rehabilitation management of neuropathic pain after spinal cord: recommendations for treatment. Spinal Cord. 2016; 54;S14–23.
Henwood P, Ellis JA. Chronic neuropathic pain in spinal cord injury: the patient’s perspective. Pain Res Manag. 2004;9:39–45.
Hicks AL, Martin KA, Ditor DS, Latimer AE, Craven C, Bugaresti J, et al. Long-term exercise training in persons with spinal cord injury: effects on strength, arm ergometry performance and psychological well-being. Spinal Cord. 2003;41:34–43.
Mulroy SJ, et al. Strengthening and optimal movements for painful shoulders (STOMPS) in chronic spinal cord injury: a randomized controlled trial. Phys Ther. 2011;91:305–24.
Curtis KA, Tyner TM, Zachary L, Lentell G, Brink D, Didyk T, et al. Effect of a standard exercise protocol on shoulder pain in long-term wheelchair users. Spinal Cord. 1999;37:421–9.
Middaugh S, et al. EMG biofeedback and exercise for treatment of cervical and shoulder pain in individuals with a spinal cord injury: a pilot study. Top Spinal Cord Inj Rehabil. 2013;19:311–23.
Norrbrink C, Lindberg T, Wahman K, Bjerkefors A. Effects of an exercise programme on musculoskeletal and neuropathic pain after spinal cord injury-results from a seated double-poling ergometer study. Spinal Cord. 2012;50:457–61.
Todd KR, Martin Ginis KA. An examination of diurnal variations in neuropathic pain and affect, on exercise and non-exercise days, in adults with spinal cord injury. Spinal Cord Ser Cases. 2018;4:94.
van der Scheer JW, Martin Ginis KA, Ditor DS, Goosey-Tolfrey V, Hicks AL, West CR, et al. Effects of exercise on fitness and health of adults with spinal cord injury: a systematic review. Neurology. 2017;89:736–45.
Martin Ginis KA, van der Scheer JW, Latimer-Cheung AE, Barrow A, Bourne C, Carruthers P, et al. Evidence-based scientific exercise guidelines for adults with spinal cord injury: An update and a new guideline. Spinal Cord. 2018;56:308–21.
Rosety-Rodriguez M, Camacho A, Rosety I, Fornieles G, Rosety MA, Diaz AJ, et al. Low-grade systemic inflammation and leptin levels were improved by arm cranking exercise in adults with chronic spinal cord injury. Arch Phys Med Rehabilitation. 2014;95:297–302.
Zhang JM, An J. Cytokines, inflammation and pain. Int Anesthesiol Clin. 2007;45:27–37.
Leung L, Cahill CM. TNF-α and neuropathic pain: a review. J Neuroinflammation. 2010;7:27.
Naugle KM, Ohlman T, Naugle KE, Riley ZA, Keith NR. Physical activity behavior predicts endogenous pain modulation in older adults. Pain. 2017;158:383–90.
Burke SM, Tomasone JR, Scime NV, Ma JK, Harden SM, Wolfe DL, et al. Physical activity self-management interventions for adults with spinal cord injury: part 2 – exploring the generalizability of findings from research to practice. Psychol Sport Exerc. 2018;37:286–95.
Hoekstra F, McBride CB, Borisoff J, Fetterly M-J, Ginis S, Latimer-Cheung AE et al. Translating the international scientific spinal cord injury exercise guidelines into community and clinical practice guidelines: a Canadian evidence-informed resource. Spinal Cord. 2020: https://doi.org/10.1038/s41393-019-0410-1.
Ma JK, Cheifetz O, Todd KR, Chebaro C, Phang SH, Shaw RB et al. Co-development of a physiotherapist-delivered physical activity intervention for adults with spinal cord injury. Spinal Cord. 2020: https://doi.org/10.1038/s41393-020-0422-x.
Ribeiro Neto F, Guanais P, Dornelas E, Coutinho ACB, Costa RRG. Validity of one-repetition maximum predictive equations in men with spinal cord injury. Spinal Cord. 2017;55:950–6.
Ma JK, West CR, Martin Ginis KA. The effects of a patient and provider co-developed, behavioral physical activity intervention on physical activity, psychosocial predictors, and fitness in individuals with spinal cord injury: a randomized controlled trial. Sports Med. 2019;49:1117–31.
Bryce TN, Biering-Sørensen F, Finnerup NB, Cardenas DD, Defrin R, Lundeberg T, et al. International Spinal Cord Injury Pain Classification: part I. Background and description. Spinal Cord. 2012;50:413–7.
Putzke JD, Richards JS, Hicken BL, DeVivo MJ. Interference due to pain following spinal cord injury: important predictors and impact on quality of life. Pain. 2002;100:231–42.
Bryce TN, Budh CN, Cardenas DD, Dijkers M, Felix ER, Finnerup NB, et al. Pain after spinal cord injury: an evidence-based review for clinical practice and research. Report of the National Institute on Disability and Rehabilitation Research Spinal Cord Injury Measures meeting. J Spinal Cord Med. 2007;30:421–40.
Hill MR, Noonan VK, Sakakibara BM, Miller WC. Quality of life instruments and definitions in individuals with spinal cord injury: a systematic review. Spinal Cord. 2010;48:438–50.
Hallstrom H, Norrbrink C. Screening tools for neuropathic pain: can they be of use in individuals with spinal cord injury? Pain. 2011;152:772–9.
Albu S, Gomez-Soriano J, Avila-Martin G, Taylor J. Deficient conditioned pain modulation after spinal cord injury correlates with clinical spontaneous pain measures. Pain. 2015;156:260–72.
Gruener H, Zeilig G, Laufer Y, Blumen N, Defrin R. Differential pain modulation properties in central neuropathic pain after spinal cord injury. Pain. 2016;157:1415–24.
Martin Ginis KA, Latimer AE, McKecknie K, Ditor DS, McCartney N, Hicks AL, et al. Using exercise to enhance subjective well-being among people with spinal cord injury: the mediating influences of stress and pain. Rehabilitation Psychol. 2003;48:157–64.
Rolke R, Baron R, Maier C, Tolle TR, Treede RD, Beyer A, et al. Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values. Pain. 2006;123:231–43.
Yarnitsky D, Arendt-Nielsen L, Bouhassira D, Edwards RR, Fillingim RB, Granot M, et al. Recommendations on terminology and practice of psychophysical DNIC testing. Eur J pain (Lond, Engl). 2010;14:339.
Matthews DR, Hosker JP, Rudenski AS, Naylor BA, Treacher DF, Turner RC. Homeostasis model assessment: insulin resistance and beta-cell function from fasting plasma glucose and insulin concentrations in man. Diabetologia. 1985;28:412–9.
Eerden S, Dekker R, Hettinga FJ. Maximal and submaximal aerobic tests for wheelchair-dependent persons with spinal cord injury: a systematic review to summarize and identify useful applications for clinical rehabilitation. Disabil Rehabil. 2018;40:497–521.
Glick HA, Doshi JA, Sonnad SS, Polsky D. Economic evaluation in clinical trials, 1st edn, New York: Oxford University Press; 2007.
Treede RD, Rief W, Barke A, Aziz Q, Bennett MI, Benoliel R, et al. Chronic pain as a symptom or a disease: the IASP Classification of Chronic Pain for the International Classification of Diseases (ICD-11). Pain. 2019;160:19–27.
Chen Y, Heinemann AW. Current research outcomes from the spinal cord injury model systems. Arch Phys Med Rehabil. 2016;97:1607–9.
Cardenas DD, Bryce TN, Shem K, Richards JS, Elhefni H. Gender and minority differences in the pain experience of people with spinal cord injury. Arch Phys Med Rehabil. 2004;85:1774–81.
We would like to acknowledge the support of research coordinator Adrienne Sinden in preparing the manuscript. We would like to acknowledge Joan Úbeda-Colomer, Emily Giroux, and Miranda Dinwoodie for their support in preparing supplementary files.
The Project Grant Program (Spring 2019) of the Canadian Institutes of Health Research (CIHR) funded this project (Grant # PJT-165903) https://cihr-irsc.gc.ca. CIHR had no role in the design of this study and will not have any role during its execution, analyses, interpretation of the data, or decision to submit results.
Conflict of interest
MEK has received consulting fees from Biogen and participated in Advisory Boards and/or Satellite Symposia of Biogen Inc. for studies related to Multiple Sclerosis. All other authors declare they have no conflict of interest.
This study protocol has been approved by the Clinical Research Ethics Board (CREB) of the University of British Columbia. All participants will provide written informed consent before taking part in the study (also see “Eligibility screening and informed consent” above). The CREB will review any protocol modifications, followed by updating the trial registration. Protocol and informed consent modifications will be made available using Open Science Framework (https://osf.io/). Informed consents will be revisited with enrolled participants if protocol modifications occur. The CREB will review any requests for use of data in an ancillary study beyond the scope of this RCT that are not covered by the original ethics application.
Publisher’s note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
About this article
Cite this article
Martin Ginis, K.A., van der Scheer, J.W., Todd, K.R. et al. A pragmatic randomized controlled trial testing the effects of the international scientific SCI exercise guidelines on SCI chronic pain: protocol for the EPIC-SCI trial. Spinal Cord 58, 746–754 (2020). https://doi.org/10.1038/s41393-020-0478-7