Skip to main content

Thank you for visiting nature.com. You are using a browser version with limited support for CSS. To obtain the best experience, we recommend you use a more up to date browser (or turn off compatibility mode in Internet Explorer). In the meantime, to ensure continued support, we are displaying the site without styles and JavaScript.

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

A Correction to this article was published on 15 July 2020

This article has been updated

Abstract

Study design

Protocol for a pragmatic randomized controlled trial (the Exercise guideline Promotion and Implementation in Chronic SCI [EPIC-SCI] Trial).

Primary objectives

To test if home-/community-based exercise, prescribed according to the international SCI exercise guidelines, significantly reduces chronic bodily pain in adults with SCI.

Secondary objectives

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.

Setting

Exercise in home-/community-based settings; assessments in university-based laboratories in British Columbia, Canada.

Method

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.

Trial registration

ClinicalTrials.gov identifier NCT04160858.

Access options

Rent or Buy article

Get time limited or full article access on ReadCube.

from$8.99

All prices are NET prices.

Fig. 1: PRagmatic Explanatory Continuum Indicator Summary (PRECIS)-2 scores for the RCT.
Fig. 2: Participant timeline: schematic diagram of enrolment, interventions, and assessments (presented according to SPIRIT guidelines).

Data availability

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).

Change history

References

  1. 1.

    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.

    Article  Google Scholar 

  2. 2.

    Finnerup NB, Baastrup C. Spinal cord injury pain: mechanisms and management. Curr pain headache Rep. 2012;16:207–16.

    Article  Google Scholar 

  3. 3.

    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.

    CAS  Article  Google Scholar 

  4. 4.

    Tran J, Dorstyn DS, Burke AL. Psychosocial aspects of spinal cord injury pain: a meta-analysis. Spinal Cord. 2016;54:640–8.

    CAS  Article  Google Scholar 

  5. 5.

    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.

    Article  Google Scholar 

  6. 6.

    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.

  7. 7.

    Henwood P, Ellis JA. Chronic neuropathic pain in spinal cord injury: the patient’s perspective. Pain Res Manag. 2004;9:39–45.

    Article  Google Scholar 

  8. 8.

    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.

    CAS  Article  Google Scholar 

  9. 9.

    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.

    Article  Google Scholar 

  10. 10.

    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.

    CAS  Article  Google Scholar 

  11. 11.

    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.

    Article  Google Scholar 

  12. 12.

    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.

    CAS  Article  Google Scholar 

  13. 13.

    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.

    Article  Google Scholar 

  14. 14.

    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.

    Article  Google Scholar 

  15. 15.

    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.

    Article  Google Scholar 

  16. 16.

    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.

    Article  Google Scholar 

  17. 17.

    Zhang JM, An J. Cytokines, inflammation and pain. Int Anesthesiol Clin. 2007;45:27–37.

    CAS  Article  Google Scholar 

  18. 18.

    Leung L, Cahill CM. TNF-α and neuropathic pain: a review. J Neuroinflammation. 2010;7:27.

    Article  Google Scholar 

  19. 19.

    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.

    Article  Google Scholar 

  20. 20.

    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.

    Article  Google Scholar 

  21. 21.

    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.

  22. 22.

    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.

  23. 23.

    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.

    CAS  Article  Google Scholar 

  24. 24.

    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.

    Article  Google Scholar 

  25. 25.

    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.

    CAS  Article  Google Scholar 

  26. 26.

    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.

    Article  Google Scholar 

  27. 27.

    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.

    Article  Google Scholar 

  28. 28.

    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.

    CAS  Article  Google Scholar 

  29. 29.

    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.

    Article  Google Scholar 

  30. 30.

    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.

    Article  Google Scholar 

  31. 31.

    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.

    Article  Google Scholar 

  32. 32.

    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.

    Article  Google Scholar 

  33. 33.

    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.

    CAS  Article  Google Scholar 

  34. 34.

    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.

    Article  Google Scholar 

  35. 35.

    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.

    CAS  Article  Google Scholar 

  36. 36.

    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.

    Article  Google Scholar 

  37. 37.

    Glick HA, Doshi JA, Sonnad SS, Polsky D. Economic evaluation in clinical trials, 1st edn, New York: Oxford University Press; 2007.

  38. 38.

    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.

    Article  Google Scholar 

  39. 39.

    Chen Y, Heinemann AW. Current research outcomes from the spinal cord injury model systems. Arch Phys Med Rehabil. 2016;97:1607–9.

    Article  Google Scholar 

  40. 40.

    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.

    Article  Google Scholar 

Download references

Acknowledgements

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.

Funding

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.

Author information

Affiliations

Authors

Contributions

KMG, JWvdS and KRD drafted sections of this manuscript. FH compiled all OSF and supplementary materials, and checked the manuscript for conformity to SPIRIT reporting guidelines. All other authors (JCD, SG, MEK, JLKK, JPL, JS, AT, CRW) substantially contributed to the conception or design of this study and drafted sections of this paper or reviewed it critically for important intellectual content. All authors approved the final version of this manuscript for publication; and agreed to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

Corresponding author

Correspondence to Kathleen A. Martin Ginis.

Ethics declarations

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.

Ethics

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.

Additional information

Publisher’s note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Supplementary information

Rights and permissions

Reprints and Permissions

About this article

Verify currency and authenticity via CrossMark

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

Download citation

Further reading

Search

Quick links