Clinical trial NCT04160858: Effects of Spinal Cord Injury Exercise Guidelines
Official title: Effects of the Spinal Cord Injury Exercise Guidelines on Pain: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chronic Pain
Spinal Cord Injuries
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2019-11-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The trial design is a two-arm, single-blinded ( i.e. assessors and analysts blinded to allocation), RCT with a 6-month intervention period and 6-month follow-up (Exercise condition only). After baseline assessments, participants will be randomly allocated to 6 mos of exercise ("Exercise") or a wait-list ("Control") using a 1:1 ratio. The trial is designed to be comparable to usual care and maximize PRECIS scores, while providing insight on mechanisms that may explain intervention effects.
Primary purpose: TREATMENT

Brief summary: 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?

Detailed description: PROPOSED TRIAL. Using an integrated knowledge translation framework (iKT), the primary aim of this pragmatic Randomized Controlled Trial (RCT) is to examine the effects of 6 months of home-/community-based exercise, prescribed according to the SCI exercise guidelines, on chronic bodily pain experienced by adults with SCI. Secondary aims are to test for 1) differential effects on musculoskeletal and neuropathic pain; 2) changes in inflammation and inhibitory control as pathways by which exercise reduces pain; 3) effects of chronic pain reductions on subjective well-being; and 4) economic benefits of the intervention.

TRIAL MANAGEMENT. The experienced team of researchers has SCI-specific expertise in exercise psychology and physiology, pain and physiatry as well as health sciences expertise in immunology, biostatistics, health economics, and pragmatic RCT design and management. The team includes knowledge users representing local, provincial and national organizations, and a collaborator with lived experience of SCI.

SIGNIFICANCE. The investigators' novel idea is that home-/community-based exercise performed according to the SCI exercise guidelines can be an effective behavioural strategy for reducing chronic pain in adults with SCI. Critically, this will be the first SCI exercise RCT to use chronic bodily pain as the primary outcome and to assess potential pathways by which exercise may alleviate pain. Furthermore, this will be the first pragmatic RCT of exercise as a behavioural pain management strategy conducted among adults with SCI. Importantly, our community-engaged, iKT approach will ensure rapid translation and dissemination of findings to Canadian and international end-users including clinicians, fitness programmers, people living with SCI and the community organizations that support them.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline, between and within group comparison, in Bodily Pain
timeFrame: Baseline, 3 months, 6 months
Secondary outcomes:
measure: International Spinal Cord Injury Pain Basic Data Set v2.0
timeFrame: Baseline, 3 months, 6 months
measure: Presence of Neuropathic Pain
timeFrame: Baseline, 3 months, 6 months
measure: Inhibitory Control of Pain assessed by Conditioned Pain Modulation
timeFrame: Baseline, 3 months, 6 months
measure: Fasting plasma concentrations of cytokines IL-6
timeFrame: Baseline, 3 months, 6 months
measure: Fasting plasma concentrations of cytokines TNF-α
timeFrame: Baseline, 3 months, 6 months
measure: Subjective Well-being: Perceived Stress
timeFrame: Baseline, 3 months, 6 months
measure: Subjective Well-being: Quality of Life
timeFrame: Baseline, 3 months, 6 months
measure: Subjective Well-being: Life Satisfaction
timeFrame: Baseline, 3 months, 6 months
measure: Subjective Well-being: Experiential Aspects of Participation
timeFrame: Baseline, 3 months, 6 months
measure: Economic Evaluation: Health Care Costs
timeFrame: Baseline, 3 months, 6 months
measure: Health-related Quality of Life
timeFrame: Baseline, 3 months, 6 months
measure: Capability Wellbeing
timeFrame: Baseline, 3 months, 6 months
measure: Inflammation Fidelity Checks
timeFrame: Baseline, 3 months, 6 months
measure: Intervention Fidelity Check: Peak power output over max aerobic arm crank test
timeFrame: Baseline, 3 months, 6 months
measure: Intervention Fidelity Check: 1 Repetition-Maximum strength test bench press
timeFrame: Baseline, 3 months, 6 months
measure: Intervention Fidelity Check : Peak oxygen uptake over max aerobic arm crank test
timeFrame: Baseline, 3 months, 6 months
measure: Intervention Fidelity Check : 1 Repetition-Maximum strength test seated row
timeFrame: Baseline, 3 months, 6 months
Other outcomes:
measure: Fidelity of the fitness trainer and exercise counselor to their protocols
timeFrame: Weekly during the intervention for the exercise group (24 weeks)
Locations:
city: Kelowna
country: Canada
facility: University of British Columbia
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Kathleen Martin Ginis, PhD
role: PRINCIPAL_INVESTIGATOR
References: