Solving SCI Pain: Pain Recovery Tools for SCI. A 7-Week Mind/Body Self-Management Program Within a 10-Week Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Behavioral Change (Engagement / Adherence)
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
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.
干预措施: Solving SCI Pain: Peer-Led Pain Self-Management Pain Tools Program (Behavioral)
结局指标
主要结局
Behavioral Change (Engagement / Adherence)
时间窗: 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
时间窗: 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.
次要结局
- Brief Pain Inventory - Severity.(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)(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)(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)(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)(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)(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)(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)(11-item measure asked: Baseline (day 1), Longer form survey (days 21, 36, 51) and post intervention (days 71, 161).)
- Subjective Happiness Scale (SHS):(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)(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)(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)(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)(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)(PGIC will be asked post intervention (days 71, 161).)
- Treatment Satisfaction Questionnaire(Treatment Satisfaction Questionnaire will be asked post intervention (days 71, 161).)
- Custom: Confidence in managing pain(This Custom Confidence question will be asked post intervention (days 71, 161).)
研究者
Kathleen Martin Ginis
Professor
University of British Columbia