EmpowerSpine Program

Официальное название

EmpowerSpine Program: A Multiphase Optimization Strategy Trial

Обзор

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.

Вмешательства

• Поведенческое 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
• Поведенческое 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.
• Поведенческое 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.
• Поведенческое 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

Первичные конечные точки

• Change in Pain [Срок оценки: Baseline to 3 month follow up]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07419646 · 5656

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗