Internet Delivered TreatmentNCT07419646
EmpowerSpine Program
A study testing EmpowerSpine, Guidance (G) and Peer Support (PS) in people with Internet Delivered Treatment and Spinal Cord Injury, run by Lawson Research Institute of St. Joseph's.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Internet Delivered Treatment, Spinal Cord Injury, Chronic Pain
- What is being tested?
- EmpowerSpine, Guidance (G) and Peer Support (PS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 1 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Internet Delivered Treatment, Spinal Cord Injury, Chronic Pain, Multidisciplinary Approach
- Being tested
- EmpowerSpine, Guidance (G), Peer Support (PS), Booster (B)
- Medical subject headings
- Spinal Cord Injuries, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmpowerSpineBehavioural
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
Guidance (G)Behavioural
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.
Peer Support (PS)Behavioural
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.
Booster (B)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| EmpowerSpine Program (ES) Self Directed | Experimental | 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 Receives: Behavioral: EmpowerSpine |
| ES and Guidance (G) | Experimental | 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. Receives: Behavioral: EmpowerSpine; Behavioral: Guidance (G) |
| ES with Peer Support (PS) | Experimental | 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. Receives: Behavioral: EmpowerSpine; Behavioral: Peer Support (PS) |
| ES and Booster (B) | Experimental | 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. Receives: Behavioral: EmpowerSpine; Behavioral: Booster (B) |
| ES+G+PS | Experimental | Participants receive ES, G, and PS Receives: Behavioral: EmpowerSpine; Behavioral: Guidance (G); Behavioral: Peer Support (PS) |
| ES+G+B | Experimental | Participants receive ES, G, and B Receives: Behavioral: EmpowerSpine; Behavioral: Guidance (G); Behavioral: Booster (B) |
| ES+PS+B | Experimental | Participants receive ES, PS, and B Receives: Behavioral: EmpowerSpine; Behavioral: Peer Support (PS); Behavioral: Booster (B) |
| ES+G+PS+B | Experimental | Participants receive ES, G, PS, and B Receives: Behavioral: EmpowerSpine; Behavioral: Guidance (G); Behavioral: Peer Support (PS); Behavioral: Booster (B) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline to 3 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Internet Delivered TreatmentStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Swati Mehta, University of Windsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07419646
- Sponsor's protocol ID
- 5656
- Status last verified
- Feb 2026
- First submitted
- 7 Feb 2026
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EmpowerSpine Program: A Multiphase Optimization Strategy Trial
- ClinicalTrials.gov ID
- NCT07419646
- Acronym / sponsor ID
- 5656
- Conditions
- Internet Delivered Treatment, Spinal Cord Injury, Chronic Pain, Multidisciplinary Approach
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 19 Feb 2026 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| EmpowerSpine Program (ES) Self Directed | Experimental | Behavioral: EmpowerSpineParticipants 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 |
| ES and Guidance (G) | Experimental | Behavioral: EmpowerSpine, 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. |
| ES with Peer Support (PS) | Experimental | Behavioral: EmpowerSpine, Behavioral: 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. |
| ES and Booster (B) | Experimental | Behavioral: EmpowerSpine, Behavioral: 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. |
| ES+G+PS | Experimental | Behavioral: EmpowerSpine, Behavioral: Guidance (G), Behavioral: Peer Support (PS)Participants receive ES, G, and PS |
| ES+G+B | Experimental | Behavioral: EmpowerSpine, Behavioral: Guidance (G), Behavioral: Booster (B)Participants receive ES, G, and B |
| ES+PS+B | Experimental | Behavioral: EmpowerSpine, Behavioral: Peer Support (PS), Behavioral: Booster (B)Participants receive ES, PS, and B |
| ES+G+PS+B | Experimental | Behavioral: EmpowerSpine, Behavioral: Guidance (G), Behavioral: Peer Support (PS), Behavioral: Booster (B)Participants receive ES, G, PS, and B |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
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 |
|---|---|---|
| EmpowerSpineParticipants 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 | Behavioural | ES and Booster (B), ES and Guidance (G), ES with Peer Support (PS), ES+G+B, ES+G+PS, ES+G+PS+B, ES+PS+B, EmpowerSpine Program (ES) Self Directed |
| 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. | Behavioural | ES and Guidance (G), ES+G+B, ES+G+PS, ES+G+PS+B |
| 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. | Behavioural | ES with Peer Support (PS), ES+G+PS, ES+G+PS+B, ES+PS+B |
| 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. | Behavioural | ES and Booster (B), ES+G+B, ES+G+PS+B, ES+PS+B |
Primary outcome
Change in Pain
Time frame: Baseline to 3 month follow up
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing EmpowerSpine, Guidance (G) and Peer Support (PS) in people with Internet Delivered Treatment and Spinal Cord Injury, run by Lawson Research Institute of St. Joseph's.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. 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: opening soon, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Swati Mehta, PhD ((519) 253-3000 ext. 2479, swati.mehta@uwindsor.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain (time frame: Baseline to 3 month follow up). 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 19 Feb 2026.