Solving SCI Pain: Pain Recovery Tools for SCI

NCT ID: NCT07212725

Last Updated: 2025-10-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-15
• Study Completion Date: 2026-03-01

Brief Summary

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:

• Does the intervention lead to meaningful changes in behavior that support pain self-management?
• Does it reduce pain interference in everyday life?

Participants will:

• Attend three 2-hour group education sessions focused on the neuroscience of pain, the role of fear-avoidance, pain-related beliefs, and body-based self-regulation tools (e.g., movement, Graston, percussion massage, and red light therapy).
• Participate in four individual coaching sessions (up to 1 hour each) designed to help them reflect on their experiences, overcome barriers, and integrate the tools into daily life.
• Follow individualized coaching recommendations and provided resources to support each participant's unique engagement with cognitive and body-based tools over the 7-week period, including light journaling, goal setting, and guided reflections.
• Complete brief check-ins every four days to monitor progress, engagement, and self-reported outcomes.

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.

Detailed 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:

1. To assess the feasibility, acceptability, and adherence to a 7-week self-management intervention/program focused on pain-related behavior change.

2. To evaluate within-person changes in pain self-management behaviors and beliefs.

3. To examine secondary outcomes, including changes in pain interference, pain severity, and emotional functioning.

4. To understand participants' experiences through qualitative feedback and thematic analysis of open-ended responses.

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.

Conditions

Spinal Cord Injury; Pain Management; Self-management Behaviors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental Pilot Group for Solving SCI Pain

Participants receive a 7-week, peer-led, neuroscience-informed pain self-management program designed for individuals with SCI and chronic pain. The program includes three 2-hour virtual group education sessions covering pain neuroscience, fear-avoidance, and optional body-based tools (e.g., movement, red light therapy, percussion massage, Graston technique). Four individualized coaching sessions (up to 1 hour each) provide tailored support. Participants engage with recommended tools between sessions and complete structured check-ins every five days. Mechanism assessments (e.g., pain beliefs, self-efficacy, emotional reactivity) are conducted during the program, with full outcome measures collected at baseline, post-intervention, and follow-up. The intervention emphasizes autonomy, personal relevance, and peer support, distinguishing it from standard clinician-led approaches.

Group Type: EXPERIMENTAL

Solving SCI Pain: Peer-Led Pain Self-Management Pain Tools Program

Intervention Type: BEHAVIORAL

Solving SCI Pain Tools is a 7-week, peer-led, neuroscience-informed pain self-management program uniquely designed for individuals with spinal cord injury (SCI) and chronic pain. It integrates cognitive and body-based tools not commonly combined in other interventions, such as red light therapy, percussion massage, Graston technique, and guided movement, alongside education on pain neurobiology and behavior change. The program is delivered virtually and emphasizes participant autonomy, optionality, and personal relevance. Distinctively, it includes multiple individualized coaching sessions led by a peer with lived experience of SCI and pain. The program does not prescribe a fixed protocol but encourages flexible, self-paced exploration supported by structured check-ins. The integration of optional, non-clinical somatic tools with behavior-change coaching and SCI-specific education distinguishes this intervention from traditional rehabilitation or pain management programs.

Interventions

Solving SCI Pain: Peer-Led Pain Self-Management Pain Tools Program

Solving SCI Pain Tools is a 7-week, peer-led, neuroscience-informed pain self-management program uniquely designed for individuals with spinal cord injury (SCI) and chronic pain. It integrates cognitive and body-based tools not commonly combined in other interventions, such as red light therapy, percussion massage, Graston technique, and guided movement, alongside education on pain neurobiology and behavior change. The program is delivered virtually and emphasizes participant autonomy, optionality, and personal relevance. Distinctively, it includes multiple individualized coaching sessions led by a peer with lived experience of SCI and pain. The program does not prescribe a fixed protocol but encourages flexible, self-paced exploration supported by structured check-ins. The integration of optional, non-clinical somatic tools with behavior-change coaching and SCI-specific education distinguishes this intervention from traditional rehabilitation or pain management programs.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

You can participate in this study if you:

• Have a spinal cord injury (SCI) from a traumatic or non-traumatic cause, experiencing neuropathic/chronic pain
• Are age 18 years or older, and living in Canada
• Can read, speak, and understand English, and have reliable internet access
• Can commit to 10 weeks of data collection (a check-in every 5th day) starting 3 weeks prior to the 7-week intervention, and a 3-month post-intervention follow-up survey.

You cannot participate in this study if you:

• Have an SCI or dysfunction from congenital (e.g., spina bifida), or, other neurological conditions (e.g., MS).
• Are currently participating in CBT or other pain-focused therapy
• Are unwilling or unable to keep pain-related medication stable for the 10-week study period

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Spinal Cord Injury Ontario

UNKNOWN

Sponsor Role: collaborator

International Collaboration on Repair Discoveries

OTHER

Sponsor Role: collaborator

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Kathleen Martin Ginis

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kathleen A Martin Ginis, PhD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

University of British Columbia

Kelowna, British Columbia, Canada

Countries

Canada

Other Identifiers

SCI Pain Intervention - N of 1

Identifier Type: -

Identifier Source: org_study_id