Spinal Cord InjuryNCT07212725
Solving SCI Pain: Pain Recovery Tools for SCI
A study testing Solving SCI Pain: Peer-Led Pain Self-Management Pain Tools Program in people with Spinal Cord Injury and Pain Management, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injury, Pain Management, Self-management Behaviors
- What is being tested?
- Solving SCI Pain: Peer-Led Pain Self-Management Pain Tools Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- 15 Sep 2025to 22 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Solving SCI Pain: Pain Recovery Tools for SCI. A 7-Week Mind/Body Self-Management Program Within a 10-Week Study
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.
Read more
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.
Read the 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:
- To assess the feasibility, acceptability, and adherence to a 7-week self-management intervention/program focused on pain-related behavior change.
- To evaluate within-person changes in pain self-management behaviors and beliefs.
- To examine secondary outcomes, including changes in pain interference, pain severity, and emotional functioning.
- 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.
- Being tested
- Solving SCI Pain: Peer-Led Pain Self-Management Pain Tools Program
- Keywords
- Spinal Cord Injury, Chronic pain, pain interference, behaviour change, pain self-management, peer-led intervention, neuroscience-based education, body-based tools
- Medical subject headings
- Spinal Cord Injuries, Agnosia, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Solving SCI Pain: Peer-Led Pain Self-Management Pain Tools ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Pilot Group for Solving SCI Pain | Experimental | 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. Receives: Behavioral: Solving SCI Pain: Peer-Led Pain Self-Management Pain Tools Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioral Change (Engagement / Adherence)
Time spent using pain relief tools.
Measured: From day 1, every 5 days until the end of the intervention (day 66). Then post intervention (day 71) and 3-month follow-up (day 161).
Brief Pain Inventory - Interference
A 7-item self-report measure assessing how pain interferes with daily activities, including general activity, mood, walking ability, work, relationships, sleep, and enjoyment of life.
A single-item short form will be used for 5-day check-ins.
Measured: 7-item measure asked: Baseline (day 1), Longer form survey (days 21, 36, 51) and post intervention (days 71, 161). 1-item short form asked on 5-day check-ins (days 6, 11, 16, 26, 31, 41, 46, 56, 61, 66).
Secondary outcomes (16)
Brief Pain Inventory - Severity.
A 4-item self-report measure assessing pain intensity at its worst, least, average, and current levels over the past 24 hours, using a 0-10 numeric rating scale. A single-item short-form ("how sever is your pain today") is provided for 5-day check-ins.
Measured: 4-item measure asked: Baseline (day 1), Longer form survey (days 21, 36, 51) and post intervention (days 71, 161). 1-item short form asked on 5-day check-ins (days 6, 11, 16, 26, 31, 41, 46, 56, 61, 66).
Douleur Neuropathique 4 (DN4)
A self-administered screening tool for neuropathic pain, consisting of 7 items assessing sensory descriptors and physical signs. A score of ≥3 suggests neuropathic pain. A single item short-form is provided for 5-day check ins.
7-item score: Minimum value = 0. Maximum value = 7
1-item short form: Min. = 0, Max =1.
Measured: 7-item measure asked: Baseline (day 1), Longer form survey (days 21, 36, 51) and post intervention (days 71, 161). 1-item short form asked on 5-day check-ins (days 6, 11, 16, 26, 31, 41, 46, 56, 61, 66).
SOPA-Emotions (Short Form)
A subscale of the Survey of Pain Attitudes assessing beliefs that emotions such as anger and depression influence pain. Higher scores reflect stronger emotional-pain belief endorsement. A single item short-form is provided for 5-day check ins.
5-item score: Min. = 0, Max = 4 (mean of 5 questions)
1-item short-form score: Min. = 0, Max =1
Measured: 5-item measure asked: Baseline (day 1), Longer form survey (days 21, 36, 51) and post intervention (days 71, 161). 1-item short form asked on 5-day check-ins (days 6, 11, 16, 26, 31, 41, 46, 56, 61, 66).
Pittsburgh Sleep Quality Index (PSQI)
A 19-item self-report questionnaire assessing sleep quality and disturbances over the past month. It yields a global score (0-21), with higher scores indicating poorer sleep quality. A single item short-form is provided for 5-day check ins.
Measured: 19-item measure asked: Baseline (day 1), Longer form survey (days 21, 36, 51) and post intervention (days 71, 161). 1-item short form asked on 5-day check-ins (days 6, 11, 16, 26, 31, 41, 46, 56, 61, 66).
Pain Catastrophizing Scale (PCS)
A 13-item self-report measure assessing catastrophic thinking related to pain. It includes subscales for rumination, magnification, and helplessness. Higher scores indicate greater catastrophizing.
PCS total score = sum of all 13 items (0-52).
Measured: 13-item measure asked: Baseline (day 1), Longer form survey (days 21, 36, 51) and post intervention (days 71, 161).
Pain Self-Efficacy Questionnaire (PSEQ)
A 10-item self-report measure assessing confidence in performing daily activities despite pain. Higher scores indicate greater pain-related self-efficacy.
PSEQ score = sum of all 10 items (0-60).
Measured: 10-item measure asked: Baseline (day 1), Longer form survey (days 21, 36, 51) and post intervention (days 71, 161).
Basic Psychological Need Satisfaction and Frustration Scale (BPNSFS)
A 12-item self-report measure assessing satisfaction and frustration of the psychological needs for autonomy, competence, and relatedness. Higher scores reflect greater need satisfaction or frustration.
Scoring: 1 - 5 (mean of items)
Measured: 12-item measure asked: Baseline (day 1), Longer form survey (days 21, 36, 51) and post intervention (days 71, 161).
Tampa Scale of Kinesiophobia (TSK-11)
An 11-item self-report measure assessing fear of movement or re-injury due to pain. Higher scores indicate greater Kinesiophobia.
Scoring: Total = sum of all (11-44).
Measured: 11-item measure asked: Baseline (day 1), Longer form survey (days 21, 36, 51) and post intervention (days 71, 161).
Subjective Happiness Scale (SHS):
A 4-item self-report measure assessing global subjective happiness. Respondents rate their overall happiness and how they compare to peers. Higher scores reflect greater subjective happiness.
4-item measure scoring: 1 - 7 (mean of 4-items).
1-item measure: 1-7
Measured: 4-item measure asked: Baseline (day 1) and post intervention (days 71, 161). 1-item short form asked: 5-day check-ins (days 6, 11, 16, 26, 31, 41, 46, 56, 61, 66) and longer form survey (days 21, 36, 51).
UCLA Loneliness Scale (Short Form)
A brief self-report measure assessing perceived social isolation and loneliness. Higher scores indicate greater feelings of loneliness. Question 4 (single item).
Scoring: 1 - 4.
Measured: This single-item measure will be asked if every survey: Baseline (day 1), 5-day check-ins (days 6, 11, 16, 26, 31, 41, 46, 56, 61, Longer form survey (days 21, 36, 51) and post intervention (days 71, 161).
PROMIS Anger (Short Form)
A self-report measure assessing the frequency and intensity of angry feelings over the past 7 days. 5-items. Higher scores indicate greater anger-related distress. A single item short-form is provided for 5-day check ins.
Scoring: sum of 8-items (8-40) converted to T-score
- short form 1-item (1-5) converted to T-score
Measured: 5-item measure asked: Baseline (day 1) and post intervention (days 71, 161). 1-item short form asked: 5-day check-ins (days 6, 11, 16, 26, 31, 41, 46, 56, 61, 66) and longer form survey (days 21, 36, 51).
PROMIS Anxiety (Short Form)
A self-report measure assessing symptoms of anxiety, such as fear, worry, and hyperarousal, over the past 7 days. 8-items. Higher scores indicate greater anxiety. A single item short-form is provided for 5-day check ins.
Scoring: sum of 7-items (7-35) converted to T-score.
- short form 1-item (1-5) converted to T-score.
Measured: 8-item measure asked: Baseline (day 1) and post intervention (days 71, 161). 1-item short form asked: 5-day check-ins (days 6, 11, 16, 26, 31, 41, 46, 56, 61, 66) and longer form survey (days 21, 36, 51).
PROMIS Depression (Short Form)
A self-report measure assessing depressive symptoms such as sadness, hopelessness, and loss of interest over the past 7 days. 8 items. Higher scores indicate greater depressive symptom severity. A single item short-form is provided for 5-day check ins.
Scoring: sum of 8-items (8-40) converted to T-score
- short form 1-item (1-5) converted to T-score
Measured: 8-item measure asked: Baseline (day 1) and post intervention (days 71, 161). 1-item short form asked: 5-day check-ins (days 6, 11, 16, 26, 31, 41, 46, 56, 61, 66) and longer form survey (days 21, 36, 51).
Patient Global Impression of Change (PGIC)
A single-item self-report measure in which participants rate their overall perception of change in health status since beginning an intervention. Higher scores indicate greater perceived improvement.
Scoring: 1-7.
Measured: PGIC will be asked post intervention (days 71, 161).
Treatment Satisfaction Questionnaire
A self-report measure assessing participants' satisfaction with various aspects of the intervention, including perceived effectiveness, ease of use, and overall experience. Higher scores indicate greater satisfaction.
Scoring: 4-items mean score (1-5).
Measured: Treatment Satisfaction Questionnaire will be asked post intervention (days 71, 161).
Custom: Confidence in managing pain
Single item open ended question to capture participant's confidence in self-managing their pain following the intervention.
Scoring: 0-10.
Measured: This Custom Confidence question will be asked post intervention (days 71, 161).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study start15 Sep 2025
- Primary completion28 Feb 2026
- Study completion22 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- N of 1
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Spinal Cord Injury Ontario, International Collaboration on Repair Discoveries
- Responsible party
- Principal investigator, Kathleen Martin Ginis, University of British Columbia
- Investigators
- Kathleen A Martin Ginis, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07212725
- Sponsor's protocol ID
- SCI Pain Intervention - N of 1
- Status last verified
- Apr 2026
- First submitted
- 19 Aug 2025
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant Data (IPD) will not be shared due to concerns regarding participant privacy and confidentiality, particularly given the small and potentially identifiable nature of the spinal cord injury community in Canada. Additionally, the data include sensitive health information that may pose risks if re-identified. The current ethics approval and participant consent do not permit public sharing of individual-level data.
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Solving SCI Pain: Pain Recovery Tools for SCI. A 7-Week Mind/Body Self-Management Program Within a 10-Week Study
- ClinicalTrials.gov ID
- NCT07212725
- Acronym / sponsor ID
- SCI Pain Intervention - N of 1
- Keywords
- Spinal Cord Injury, Chronic pain, pain interference, behaviour change, pain self-management, peer-led intervention, neuroscience-based education, body-based tools
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Spinal Cord Injury Ontario, International Collaboration on Repair Discoveries
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 28 Feb 2026 (actual)
- Study completion
- 22 Apr 2026 (actual)
- First posted
- 8 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To assess the feasibility, acceptability, and adherence to a 7-week self-management intervention/program focused on pain-related behavior change.
- To evaluate within-person changes in pain self-management behaviors and beliefs.
- To examine secondary outcomes, including changes in pain interference, pain severity, and emotional functioning.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- N of 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Pilot Group for Solving SCI Pain | Experimental | Behavioral: Solving SCI Pain: Peer-Led Pain Self-Management Pain Tools ProgramParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Solving SCI Pain: Peer-Led Pain Self-Management Pain Tools ProgramSolving 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. | Behavioural | Experimental Pilot Group for Solving SCI Pain |
Primary outcome
Behavioral Change (Engagement / Adherence)
Time frame: From day 1, every 5 days until the end of the intervention (day 66). Then post intervention (day 71) and 3-month follow-up (day 161).
Time spent using pain relief tools.
Brief Pain Inventory - Interference
Time frame: 7-item measure asked: Baseline (day 1), Longer form survey (days 21, 36, 51) and post intervention (days 71, 161). 1-item short form asked on 5-day check-ins (days 6, 11, 16, 26, 31, 41, 46, 56, 61, 66).
A 7-item self-report measure assessing how pain interferes with daily activities, including general activity, mood, walking ability, work, relationships, sleep, and enjoyment of life. A single-item short form will be used for 5-day check-ins.
16 secondary outcomes
Brief Pain Inventory - Severity.
Time frame: 4-item measure asked: Baseline (day 1), Longer form survey (days 21, 36, 51) and post intervention (days 71, 161). 1-item short form asked on 5-day check-ins (days 6, 11, 16, 26, 31, 41, 46, 56, 61, 66).
Douleur Neuropathique 4 (DN4)
Time frame: 7-item measure asked: Baseline (day 1), Longer form survey (days 21, 36, 51) and post intervention (days 71, 161). 1-item short form asked on 5-day check-ins (days 6, 11, 16, 26, 31, 41, 46, 56, 61, 66).
SOPA-Emotions (Short Form)
Time frame: 5-item measure asked: Baseline (day 1), Longer form survey (days 21, 36, 51) and post intervention (days 71, 161). 1-item short form asked on 5-day check-ins (days 6, 11, 16, 26, 31, 41, 46, 56, 61, 66).
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 19-item measure asked: Baseline (day 1), Longer form survey (days 21, 36, 51) and post intervention (days 71, 161). 1-item short form asked on 5-day check-ins (days 6, 11, 16, 26, 31, 41, 46, 56, 61, 66).
Pain Catastrophizing Scale (PCS)
Time frame: 13-item measure asked: Baseline (day 1), Longer form survey (days 21, 36, 51) and post intervention (days 71, 161).
Pain Self-Efficacy Questionnaire (PSEQ)
Time frame: 10-item measure asked: Baseline (day 1), Longer form survey (days 21, 36, 51) and post intervention (days 71, 161).
Basic Psychological Need Satisfaction and Frustration Scale (BPNSFS)
Time frame: 12-item measure asked: Baseline (day 1), Longer form survey (days 21, 36, 51) and post intervention (days 71, 161).
Tampa Scale of Kinesiophobia (TSK-11)
Time frame: 11-item measure asked: Baseline (day 1), Longer form survey (days 21, 36, 51) and post intervention (days 71, 161).
Subjective Happiness Scale (SHS):
Time frame: 4-item measure asked: Baseline (day 1) and post intervention (days 71, 161). 1-item short form asked: 5-day check-ins (days 6, 11, 16, 26, 31, 41, 46, 56, 61, 66) and longer form survey (days 21, 36, 51).
UCLA Loneliness Scale (Short Form)
Time frame: This single-item measure will be asked if every survey: Baseline (day 1), 5-day check-ins (days 6, 11, 16, 26, 31, 41, 46, 56, 61, Longer form survey (days 21, 36, 51) and post intervention (days 71, 161).
PROMIS Anger (Short Form)
Time frame: 5-item measure asked: Baseline (day 1) and post intervention (days 71, 161). 1-item short form asked: 5-day check-ins (days 6, 11, 16, 26, 31, 41, 46, 56, 61, 66) and longer form survey (days 21, 36, 51).
PROMIS Anxiety (Short Form)
Time frame: 8-item measure asked: Baseline (day 1) and post intervention (days 71, 161). 1-item short form asked: 5-day check-ins (days 6, 11, 16, 26, 31, 41, 46, 56, 61, 66) and longer form survey (days 21, 36, 51).
PROMIS Depression (Short Form)
Time frame: 8-item measure asked: Baseline (day 1) and post intervention (days 71, 161). 1-item short form asked: 5-day check-ins (days 6, 11, 16, 26, 31, 41, 46, 56, 61, 66) and longer form survey (days 21, 36, 51).
Patient Global Impression of Change (PGIC)
Time frame: PGIC will be asked post intervention (days 71, 161).
Treatment Satisfaction Questionnaire
Time frame: Treatment Satisfaction Questionnaire will be asked post intervention (days 71, 161).
Custom: Confidence in managing pain
Time frame: This Custom Confidence question will be asked post intervention (days 71, 161).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Individual participant dataSharing planned: No. Individual Participant Data (IPD) will not be shared due to concerns regarding participant privacy and confidentiality, particularly given the small and potentially identifiable nature of the spinal cord injury community in Canada. Additionally, the data include sensitive health information that may pose risks if re-identified. The current ethics approval and participant consent do not permit public sharing of individual-level data.
Related trials for Spinal Cord Injury
Recruiting
Evaluating Long-term Use of a Pediatric Robotic Exoskeleton (P.REX/Agilik) to Improve Gait in Children With Movement Disorders
Cerebral Palsy, Muscular Dystrophy
Active, not recruitingObservational study
Nerve Transfer Surgery to Restore Upper-limb Function After Cervical Spinal Cord Injury
Spinal Cord Injury, Spinal Cord Injury at C5-C7 Level
Recruiting
Implementing a Decision Support Tool to Prevent Community-Acquired Pressure Injury in Spinal Cord Injury (SCI) in the Spinal Cord Injury Clinic
Spinal Cord Injury, Pressure Injury
Recruiting
Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Tablet-01)
Brainstem Stroke, ALS
Recruiting
A Neuroprosthesis for Seated Posture and Balance
Spinal Cord Injury, Paralysis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen A Martin Ginis, PhD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Solving SCI Pain: Peer-Led Pain Self-Management Pain Tools Program in people with Spinal Cord Injury and Pain Management, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavioral Change (Engagement / Adherence) (time frame: From day 1, every 5 days until the end of the intervention (day 66). Then post intervention (day 71) and 3-month follow-up (day 161).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.