Menu
Not yet recruiting NCT07419646

EmpowerSpine Program

No phase Interventional Internet Delivered Treatment Spinal Cord Injury Chronic Pain Multidisciplinary Approach

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: EmpowerSpine, Guidance (G), Peer Support (PS), Booster (B).
Who it may be relevant to
Registry conditions: Internet Delivered Treatment, Spinal Cord Injury, Chronic Pain, Multidisciplinary Approach. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

EmpowerSpine Program: A Multiphase Optimization Strategy Trial

Overview

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.

Interventions

  • 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 (in
  • 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

Primary outcome measures

  • Change in Pain [Time frame: Baseline to 3 month follow up]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Factorial
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07419646 · 5656

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗