EmpowerSpine Program

EmpowerSpine Program: A Multiphase Optimization Strategy 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Pain; Spinal Cord Injury; Internet Delivered Treatment; Multidisciplinary Approach
• Intervention / Treatment: Behavioral: EmpowerSpine; Behavioral: Guidance (G); Behavioral: Peer Support (PS); Behavioral: Booster (B)

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Swati Mehta, PhD; Phone Number: 2479 (519) 253-3000; Email: swati.mehta@uwindsor.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 18 years of age or older
• Canadian residents
• identify as sustaining an SCI
• living in the community
• pain intensity ≥3 on the numeric rating scale

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EmpowerSpine Program (ES) Self Directed; Participants 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	Behavioral: EmpowerSpine; Participants 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
Experimental: ES and Guidance (G); Guidance: 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.	Behavioral: EmpowerSpine; Participants 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; Behavioral: Guidance (G); Guidance: 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.
Experimental: ES with Peer Support (PS); In addition to ES program, participants 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.	Behavioral: EmpowerSpine; Participants 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; Behavioral: Peer Support (PS); Participants 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.
Experimental: ES and Booster (B); Along with ES program, participants 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.	Behavioral: EmpowerSpine; Participants 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; Behavioral: Booster (B); Participants 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.
Experimental: ES+G+PS; Participants receive ES, G, and PS	Behavioral: EmpowerSpine; Participants 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; Behavioral: Guidance (G); Guidance: 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.; Behavioral: Peer Support (PS); Participants 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.
Experimental: ES+G+B; Participants receive ES, G, and B	Behavioral: EmpowerSpine; Participants 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; Behavioral: Guidance (G); Guidance: 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.; Behavioral: Booster (B); Participants 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.
Experimental: ES+PS+B; Participants receive ES, PS, and B	Behavioral: EmpowerSpine; Participants 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; Behavioral: Peer Support (PS); Participants 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.; Behavioral: Booster (B); Participants 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.
Experimental: ES+G+PS+B; Participants receive ES, G, PS, and B	Behavioral: EmpowerSpine; Participants 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; Behavioral: Guidance (G); Guidance: 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.; Behavioral: Peer Support (PS); Participants 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.; Behavioral: Booster (B); Participants 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline to 3 month follow up

Collaborators and Investigators

• Sponsor: Lawson Research Institute of St. Joseph's

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: February 7, 2026
• First Submitted That Met QC Criteria: February 13, 2026
• First Posted (Actual): February 19, 2026

Study Record Updates

• Last Update Posted (Actual): February 19, 2026
• Last Update Submitted That Met QC Criteria: February 13, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Chronic Pain; Spinal Cord Injuries; Investigative Techniques; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Community Health Services; Behavioral Disciplines and Activities; Mental Health Services; Biological Therapy; Immunologic Techniques; Immunomodulation; Immunization; Immunotherapy; Counseling; Immunization, Secondary
• Other Study ID Numbers: 5656

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No