EmpowerSpine Program
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLawson Research Institute of St. Joseph's
About this trial
Chronic pain affects over 60% of individuals living with spinal cord injuries (SCI), significantly impairing their daily lives and overall well-being. Traditional treatments like medications often provide limited relief and come with unwanted side effects. Recognizing this gap, the EmpowerSpine program was co-developed as an innovative, online, multidisciplinary pain management solution tailored for individuals with SCI. EmpowerSpine equips participants with evidence-based tools, including education about pain biology, behavioural strategies to manage daily activities, and techniques to improve self-monitoring and resilience. Delivered through an accessible digital platform, the program is designed to overcome barriers such as limited mobility, high costs, and geographic constraints. In initial trials, EmpowerSpine demonstrated high levels of satisfaction and adherence among participants, with improvements in pain intensity, mental health, and quality of life.
The proposed research seeks to refine EmpowerSpine using the multiphase optimization strategy (MOST), a pragmatic research framework, to identify which components of the program (i.e. clinician guidance, peer support groups, follow-up booster sessions) yield the best outcomes. A randomized controlled trial involving 100 participants will evaluate the program's impact on self-efficacy, pain levels, and overall quality of life. This work aims to optimize EmpowerSpine for scalability, making it a sustainable and effective resource for individuals with SCI across Canada. By leveraging partnerships with patient organizations and healthcare providers, the research will ensure the program addresses real-world needs and is positioned for widespread implementation. EmpowerSpine has the potential to revolutionize how chronic pain is managed in the SCI community, offering a scalable model of care that combines technology, evidence-based practices, and patient-centered approaches to improve lives.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 years of age or older
Canadian residents
identify as sustaining an SCI
living in the community
Disqualifiers
have pain intensity<3;
present with severe mental health disorder requiring face-to-face therapy (e.g., severe suicide ideation, recent history of psychosis, mania)
Trial design
Design model
Factorial
Treatments tested in this trial
EmpowerSpine
BehavioralParticipants will receive the 10-week tailored EmpowerSpine program previously co-developed by the Team and Patient Oriented Steering Committee. The program consists of 1) education designed to improve participants' understanding of the biopsychosocial nature of chronic pain by presenting information on the nature of pain biology, address erroneous beliefs about pain (e.g. that chronic pain is always associated with pathology) and outline links between chronic pain and health behaviour risks (inactivity, weight, smoking, and so on); 2) behavioural activation through goal setting and development of a physical activity action and coping plan; 3) managing overdoing-underdoing cycle of activity levels, tackling fear avoidance; 4) developing self-monitoring and regulation practices; 5) occurrence of setbacks, signs of setbacks and creating setback plans. Materials will be presented in a didactic (i.e., text-based and audio with visual images and animation videos) and case-enhanced learning
Guidance (G)
BehavioralGuidance: Weekly Guidance will be provided by a trained Guide. The Guide will spend \~15 -20 mins. per week/per participant. Weekly interaction will consist of: 1) assist participants practice skills, reinforce progress, engage with the program; 2) guide participants to learn material, highlight lesson content, answer questions, and problem solve on how to apply skills; 3) provide support through warmth and concern; 4) monitor symptoms and risk management.
Peer Support (PS)
BehavioralParticipants will receive focused peer group discussions. Focused Peer Group Discussion: The focused discussion will take the form of a group based virtual session of approximately 6-8 participants in each group The Groups will be moderated by a team member once every two weeks for the duration of the 10-week program.
Booster (B)
BehavioralParticipants will receive a booster session workshop Booster sessions: Participants allocated to receive booster sessions will have access to a booster module and workshop at 16 weeks post enrollment. The booster module will include online materials that review core skills such as thought challenging, deep breathing, behavioural activation, and graded exposure. The module will also discuss how to maintain motivation and continue to practice skills regularly. The Booster module will also include a Do-It-Yourself Guide for participants to print and practice the skills they have learned throughout the course. A group based workshop will be provided to participants to review the booster module.
Treatment groups
100 Participants
are divided into 8 treatment groups8
Treatment groupsSee each treatment group below.
Group A: EmpowerSpine Program (ES) Self DirectedExperimental treatment 1 intervention
Group B: ES and Guidance (G)Experimental treatment 2 interventions
Group C: ES with Peer Support (PS)Experimental treatment 2 interventions
Group D: ES and Booster (B)Experimental treatment 2 interventions
Group E: ES+G+PSExperimental treatment 3 interventions
Group F: ES+G+BExperimental treatment 3 interventions
Group G: ES+PS+BExperimental treatment 3 interventions
Group H: ES+G+PS+BExperimental treatment 4 interventions
Trial outcomes
Primary outcomes
1
Change in Pain
Brief Pain Inventory Short Form: assesses pain severity and functional interference using 0-10 numeric rating scales. It calculates two main indices: Pain Severity (average of 4 items) and Pain Interference (average of 7 items), with higher scores (0-10) indicating greater intensity or impairment
Time frame
Baseline to 3 month follow upLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Lawson Research Institute of St. Joseph's
Lead sponsor
University of Windsor
Sponsor institution
Source ClinicalTrials.gov
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