Effects of Spinal Cord Injury Exercise Guidelines
Unknown statusNot applicableNCT04160858
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Brief summary (from the registry)
Over 85,000 Canadians live with a spinal cord injury (SCI). The vast majority experience chronic pain from neuropathic or musculoskeletal origins, with many reporting the pain to be more physically, psychologically and socially debilitating than the injury itself. Currently, pharmaceuticals are the front line treatment recommendation for SCI pain, despite having many side-effects and giving minimal relief. Alternatively, studies conducted in controlled lab and clinical settings suggest that exercise may be a safe, effective behavioural strategy for reducing SCI-related chronic pain. Two ways in which exercise may alleviate pain are by reducing inflammation and increasing descending inhibitory control. To date, no study has tested the effects of exercise, performed in a home-/community-setting, on chronic pain in adults with SCI. Furthermore, information on the exercise dose required to alleviate chronic SCI pain is virtually non-existent, making it impossible for clinicians and fitness trainers to make evidence- informed recommendations regarding the types and amounts of exercise to perform in order to manage SCI pain. Recently (2018), an international team published two scientific SCI exercise guidelines: one to improve fitness and one to improve cardiometabolic health. These scientific guidelines have been translated into Canadian community SCI exercise guidelines and provide the exercise prescription for the proposed study. The investigators' overarching research question is: can home-/community-based exercise-prescribed according to these new SCI exercise guidelines and supported through a theory-based behavioural intervention- significantly reduce chronic pain in adults with SCI?
Study details
- Official title
- Effects of the Spinal Cord Injury Exercise Guidelines on Pain: A Randomized Controlled Trial
- Conditions
- Interventions
- Sponsor
- University of British Columbia
- Start date
- 2020-01-16
- Primary completion
- 2025-02-14
- Sex
- All
- Age range
- from 18 Years
- Healthy volunteers
- true
- Results posted
- No results posted in this snapshot
- Countries
- Canada
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * (i) adults aged \>18 with an spinal cord injury (SCI), traumatic or non-traumatic cause; * (ii) ASIA impairment scale classifications A-D, injury levels C3 or below; * (iii) \>12 mos post-injury \[criteria i-iii capture the group to whom the SCI Exercise Guidelines apply); * (iv) reporting chronic pain, defined as pain that persists or recurs for more than 3 mos on a question taken from the US Model SCI Systems measures: \["Using a 0 to 10 scale with 10 being pain so severe you could not stand it and 0 being no pain, what has been the usual level of pain over the past 3 months?"\] and scoring at or above 1; * (v) report pain secondary to SCI that is classified as neuropathic and/or musculoskeletal (MSK) using theInternational SCI Pain Basic Data Set (v2.0) pain descriptions. \[The trial physiatrist will train the research coordinators to use the Data Set and will make final decisions on unclear cases.\]; * (vi) report \<40 min/wk of structured, moderate intensity, aerobic exercise and \<2 bouts/week of strength training (i.e. less than the Starting Level guideline) on a modified version of the Leisure Time Physical Activity Questionnaire-SCI (\<15% of Canadians with SCI currently achieve the Starting Level so the trial can assess the effects of increasing exercise to recommended levels; * (vii) no medical contra-indications to performing a maximal exercise test; * (viii) have access to a phone. Exclusion Criteria: * (i) chronic pain with exclusively non-MSK or non-neuropathic origins (e.g. headache, abdominal pain-because the effects of exercise on these pain types are unknown); * (ii) insufficient diaphragmatic control and arm functioning to do upper-body exercise; * (iii) live beyond driving distance of the research site; * (iv) insufficient English language proficiency to complete questionnaires and converse with the fitness trainer and counselor; * (v) have been previously told s/he has a cognitive or memory impairment; * (vi) pregnant (because safety of the guidelines are unknown); * (vii) hospital in-patient at the time of enrolment.
Canadian sites (1)
| Facility | City | Province |
|---|---|---|
| University of British Columbia | Kelowna | British Columbia |
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04160858