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Brief Summary The goal of this clinical trial is to evaluate whether a neuroscience-informed, peer-led self-management program can promote behavior change and reduce pain interference in adults with spinal cord injury (SCI) and chronic pain. The primary aim is to support participants in developing practical, sustainable strategies for managing chronic pain through education, reflection, and consistent application of self-management tools. The program is designed to shift participants from passive recipients of care to active agents in their own pain management process.
Chronic pain is highly prevalent among individuals with SCI, and many report that traditional treatments - primarily pharmacological - provide limited relief and are accompanied by significant side effects. There is a growing need for accessible, non-clinical interventions that empower individuals to manage pain based on the latest neuroscience and behavior change principles.
Solving SCI Pain intervention is a 7-week, multi-component program grounded in brain-based pain science, neuroplasticity, and behavior change models. The main questions it aims to answer are:
Participants will:
Group and coaching sessions will be recorded and transcribed to support qualitative analysis, allowing researchers to understand how the intervention is experienced and delivered. This will help refine the program for future implementation and scaling. The study prioritizes accessibility, relevance, and peer involvement to address the real-world needs of individuals living with SCI and chronic pain.
Full description
Population:
In 2010, it was estimated that over 85,000 Canadians were living with a Spinal Cord Injury (SCI) (Noonan et al., 2012). The severity of the disability associated with SCI varies, depending on the level and completeness of the injury. However, it is common for damage to the spinal cord to result in the loss or severe impairment of mobility, as well as leading to a myriad of secondary health complications (Nash, 2005). Neuropathic pain (NP), experienced by approximately 75% of persons with SCI experience, is one such side effect. Often described as a burning, shooting or stabbing sensation, many who experience it report it being more debilitating than the injury itself (Burke et al., 2017). Currently, treatment options for NP are extremely limited, with pharmaceuticals most often being prescribed to alleviate pain symptoms. Unfortunately, the negative side-effects they elicit are often more unbearable than the actual pain, and with only 30% of individuals reporting a 50% reduction in NP, (Finnerup et al., 2001) many prefer non-pharmaceutical alternatives.(Löfgren & Norrbrink, 2012).
Purpose:
This study aims to evaluate the feasibility and individual-level impact of a 10-week, neuroscience-informed intervention designed to support behavior change in pain self-management among individuals with SCI. The overall study is 10 weeks in duration, with a 7-week intervention and a 3-month post-intervention follow-up data collection.
Hypothesis:
Participants who engage with the program will demonstrate within-person changes in pain-related behaviors, beliefs, and self-regulation strategies. These behavioral shifts are expected to precede reductions in pain interference.
Justification:
Chronic pain after SCI is common and highly disruptive, yet many existing interventions are delivered in group formats that do not flexibly adapt to the diverse and complex needs of individuals. This study addresses that gap by using a personalized, N-of-1 design and a neuroscience-informed approach that supports participants in changing how they think about and respond to pain. Rather than focusing solely on symptom suppression, the program aims to empower participants with tools for self-directed recovery-and to foster the belief that meaningful change, and even healing, is possible.
Objectives:
Research Design and Methods This is a prospective, observational N-of-1 study designed to evaluate the feasibility and individual-level impact of a neuroscience-informed pain self-management intervention for individuals with spinal cord injury (SCI). The study spans 10 weeks, with data collection beginning on Day 1 (20 days prior to the intervention) and continuing every five days throughout the intervention period. A three-month post-intervention follow-up survey is also administered to assess longer-term outcomes.
The intervention itself is seven weeks in duration and is delivered in a non-clinical, coaching-based format. It begins with a 120-minute group education session on Day 22, focused on brain-based pain science and the rationale for behavior change. Participants are then provided with supporting resources to read and view, including the self-help book The Way Out (Gordon, 2022), which introduces principles of Pain Reprocessing Therapy. Additional 120-minute group education sessions are delivered on Day 36 (Optional Body-Based Tools) and Day 64 (Integration, Progress, and Long-Term Self-Management). Up to 60 minutes of peer coaching is offered weekly between group sessions on Days 29-30, 44-45, 50-51, and 57-58. A more detailed explanation of the intervention content and delivery is provided in Section 5.6.
Data are collected via four different online surveys hosted on Qualtrics: Baseline (Day 1), 5-Day Check-In (Days 6, 11, 21, 31, 36, 41, 46, 56, 61, and 66), Mediator Assessments (Days 21, 36, and 51), and Follow-Up (Days 71 and 161). All surveys contain a core set of self-report measures assessing pain interference, pain-related beliefs, emotional functioning, and behavior change processes. The 5-Day Check-In survey includes brief forms of selected measures to reduce participant burden (estimated completion time: 5 minutes), while the other surveys take approximately 20-25 minutes. Open-ended questions are included across all time points to capture qualitative feedback on participant experiences and perceived change.
Statistical Analysis:
Descriptive statistics will be used to assess feasibility and participant characteristics. Within-person change will be evaluated using repeated-measures analyses and time-series plots. Exploratory correlations will examine relationships between engagement and outcome change. Qualitative data will be thematically analyzed to capture participant perspectives, experiences, and perceived mechanisms of change.
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You can participate in this study if you:
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Data sourced from clinicaltrials.gov
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