Development of a Pain Rehabilitation Program for Chronic Pain After SCI
Feasibility of a New Digital Pain Rehabilitation Program for People With SCI
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:
- Develop a new digital pain rehabilitation program, adapted for the needs of people living with an SCI.
- To investigate the feasibility and acceptability of a new digital pain rehabilitation program.
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Gunilla Stenberg, Docent
- 전화번호: +46 90 7869895
- 이메일: gunilla.stenberg@umu.se
연구 연락처 백업
- 이름: Sofia Björkbacka, MSc
- 전화번호: 0046907869349
- 이메일: sofia.bjorkbacka@umu.se
연구 장소
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Umeå, 스웨덴, 90736
- Inst. Community Medicine and Rehabilitation
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- two years since injury
- Stable pain medication?
Exclusion Criteria:
- severe cognitive impairment
- Alcohol or drug abuse
- does not understand Swedish
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Spinal cord injury (SCI) and chronic pain
People with chronic pain after spinal cord injury
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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 discussions led by clinicians with long experience in pain rehabilitation and SCI.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Recruitment rate, number recruited per quarter
기간: At enrollment
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Continue=6 Solve=4 Stop=3
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At enrollment
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Number of participant with treatment-related advere events as assessed by...
기간: From enrollment to the end of tretment at 8 weeks
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From enrollment to the end of tretment at 8 weeks
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Participant retention- Completion rates
기간: The end of the 8- week program
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>75% continue, 50-75% Solve, <50% stop
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The end of the 8- week program
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Program Adherence
기간: The end of the 8-week program
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Continue >75%, solve 50-75%, stop <50%
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The end of the 8-week program
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Patients' self-perceived relevance, timing and mode of delivery
기간: >70% Continue, Solve 50-70%, Stop <50%
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Patient evaluation, satisfied patients
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>70% Continue, Solve 50-70%, Stop <50%
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Assessment procedure acceptance- Patient evaluations, proportions of completed questionnaires
기간: At the end of the 8-week program
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>80% continue, 50-80% solve, <50% stop
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At the end of the 8-week program
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Fidelity of delivery - Process evaluations
기간: End of the 8-week program
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End of the 8-week program
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2023-04232-01
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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