Chronic Pain Self-Management Support With Pain Education and Exercise (COMMENCE): A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- McMaster University
- Enrollment
- 102
- Locations
- 1
- Primary Endpoint
- Short-Musculoskeletal Function Assessment - Dysfunction Index
Study Overview
Brief Summary
The purpose of this study is to determine whether the combination of self-management support, pain science education, and individualized, goal-oriented exercises helps people with chronic pain to increase their function.
Detailed Description
Primary objective: This study will test the hypothesis that participants with chronic pain experience greater change in function with ChrOnic pain self-ManageMent support with pain science EducatioN and exerCisE (COMMENCE) in comparison to a wait-list control.
Secondary objective #1: This study will test the hypotheses that people with chronic pain experience greater change in pain intensity, pain interference, self-efficacy, catastrophic thinking, fear of movement/re-injury, pain neurophysiology knowledge, how much participants are bothered by difficulty with functional activities, fatigue, depressive symptoms, health care utilization and work status with COMMENCE in comparison to a wait-list control.
Secondary objective #2: This study will identify demographic, psychological, or psychophysical variables that are predictive of treatment response.
Design: This study will be a randomized trial with parallel groups, a wait-list control and balanced randomization. A cross-over will take place after a 12-week follow-up assessment (ie. the group initially receiving treatment will receive no treatment and the group initially on the wait-list will receive treatment for 6 weeks). The between group comparison will be performed using only the data up to the 12-week follow-up due to anticipated carry-over effects with self-management support. Data collected after the cross-over will be used to help identify factors that predict response to the intervention.
Blinding: Due to the nature of the treatment and comparison, participants and the treating physiotherapist will not be blinded. The assessor who is completing the two objective measures will be blind to the treatment allocation. Data analysis will be performed by someone who is not blinded to the group allocation.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •participants will all be adults who have been experiencing non-cancer related pain for at least 12 weeks
Exclusion Criteria
- •cancer related pain
- •medical "red flags" suggestive of a non-neuromusculoskeletal etiology of symptoms
- •casted fracture within the last 12 weeks
- •related surgery within the last 26 weeks
- •evidence of upper motor neuron lesion
Arms & Interventions
COMMENCE
ChrOnic pain self-ManageMent support with pain science EducatioN and exerCisE (COMMENCE)
Intervention: COMMENCE (Behavioral)
Wait-list control
No treatment assigned
Outcomes
Primary Outcomes
Short-Musculoskeletal Function Assessment - Dysfunction Index
Time Frame: change in function from baseline at 18 weeks (12 week follow-up) with repeated measures at 0, 7 and 18 weeks
Measures function
Secondary Outcomes
- Patient Health Questionnaire - 9(change in depressive symptoms from baseline at 18 weeks (12 week follow-up) with repeated measures at 0, 7 and 18 weeks)
- Pain Catastrophizing Scale(change in catastrophizing from baseline at 18 weeks (12 week follow-up) with repeated measures at 0, 7 and 18 weeks)
- Tampa Scale of Kinesiophobia - 11-item(change in fear of movement/re-injury from baseline at 18 weeks (12 week follow-up) with repeated measures at 0, 7 and 18 weeks)
- Pain Self-Efficacy Questionnaire(change in self-efficacy from baseline at 18 weeks (12 week follow-up) with repeated measures at 0, 7 and 18 weeks)
- Neurophysiology of Pain Questionnaire - Revised(change in knowledge from baseline at 18 weeks (12 week follow-up) with repeated measures at 0, 7 and 18 weeks)
- Short-Musculoskeletal Function Assessment - Bother Index(change in bother index from baseline at 18 weeks (12 week follow-up) with repeated measures at 0, 7 and 18 weeks)
- Numeric Pain Rating Scale(change in pain intensity from baseline at 18 weeks (12 week follow-up) with repeated measures at 0, 7 and 18 weeks)
- PROMIS Pain Interference Item-Bank - 8 Items(change in pain interference from baseline at 18 weeks (12 week follow-up) with repeated measures at 0, 7 and 18 weeks)
- Numeric Fatigue Rating Scale(change in fatigue from baseline at 18 weeks (12 week follow-up) with repeated measures at 0, 7 and 18 weeks)
- Number of health care visits over 12 weeks(change in number of health care visits from 12-weeks immediately prior to treatment to number of visits during 12-week follow-up period)
- Work status(Change in work status from baseline at 18 weeks)
- Adverse events or harms reported(Number of adverse events reported during 6 week treatment period)
- Number of visits attended(Number of visits during 6 week treatment period)