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Набор скоро начнётся NCT07634796

Development of a Pain Rehabilitation Program for Chronic Pain After SCI

Без фазы С лечением Spinal Cord Injuries Chronic Pain Neuropathic Pain Interprofessional Team Collaboration

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: multi-modality pain management.
Кому может быть актуально
Состояния в реестре: Spinal Cord Injuries, Chronic Pain, Neuropathic Pain, Interprofessional Team Collaboration. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Швеция
Следующий шаг
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Официальное название

Feasibility of a New Digital Pain Rehabilitation Program for People With SCI

Обзор

Pain rehabilitation programs are essential for optimal treatment of chronic pain and are usually based on the biopsychosocial model. This is, however, not standard care for people with chronic pain after a spinal cord injury (SCI) due to a biomedical focused perspective of SCI and lack of adapted programs. The aims of this feasibility study: 1. Develop a new digital pain rehabilitation program, adapted for the needs of people living with an SCI. 2. To investigate the feasibility and acceptability of a new digital pain rehabilitation program.

Подробное описание

This study follows the guidelines of Medical Research Council for complex interventions and the proposed iterative feasibility process to improve and prepare the intervention for future testing in an RCT study. The research group will, toghether with a reference groups, develop a digital intervention porposal. The program will be a team-based, goal-oriented program for patients with spinal cord injury (SCI) and chronic pain.

In this study, eligible participants are included in an 8 week pain rehabilitation program. The program is developed through user-involvement i.e. together with clinicians (experienced in pain rehabilitation and/or SCI rehabilitation), stakeholders, researchers and individuals with SCI. The program will include video material for education, home exercises and group discussions led by clinicians with long experience in pain rehabilitation and SCI.

The participants will fill in self-assessed questionaries at baseline and after the finish of the program about their pain, sleep, mood and quality of life. After the program some of the participants will be asked to participate in semi-structured interviews about how they navigate and engage with different components of the program. The patients will be recruited during a rutine follow up at an SCI clinic.

Seven factors will be studied to assess the feasibility and acceptability of the program, based on set goals according to the Traffic Light method.

Вмешательства

  • Другое multi-modality pain management
    8- week pain rehabilitation program. The first meeting of the program is located at a hospital facility and thereafter they will meet at a digital platform.The program include education, home exercises and group meetings. The program consists of 4 modules. 1. Physical exercise and ergonomics. 2. Structure and recovery. 3. Employment/occupation and social support. 4. ACT and coping. Each module lasts for two weeks. The program will include video material for education, home exercises and group di

Первичные конечные точки

  • Recruitment rate, number recruited per quarter [Срок оценки: At enrollment]
  • Number of participant with treatment-related advere events as assessed by... [Срок оценки: From enrollment to the end of tretment at 8 weeks]
  • Participant retention- Completion rates [Срок оценки: The end of the 8- week program]
  • Program Adherence [Срок оценки: The end of the 8-week program]
  • Patients' self-perceived relevance, timing and mode of delivery [Срок оценки: >70% Continue, Solve 50-70%, Stop <50%]
  • Assessment procedure acceptance- Patient evaluations, proportions of completed questionnaires [Срок оценки: At the end of the 8-week program]
  • Fidelity of delivery - Process evaluations [Срок оценки: End of the 8-week program]

Критерии участия

Критерии включения

  • two years since injury
  • Stable pain medication?

Критерии исключения

  • severe cognitive impairment
  • Alcohol or drug abuse
  • does not understand Swedish

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Швеция · 1 центр
  • Inst. Community Medicine and Rehabilitation — Umeå

Идентификаторы

NCT: NCT07634796 · 2023-04232-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗