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| Name | Class |
|---|---|
| Region Västerbotten | OTHER_GOV |
| Riksförbundet för Trafik, Olycksfall och Polioskadade (RTP), Sundbyberg, Sweden | UNKNOWN |
| Norrbacka-Eugenia Foundation | OTHER |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spinal cord injury (SCI) and chronic pain | Experimental | People with chronic pain after spinal cord injury |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| multi-modality pain management | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment rate, number recruited per quarter | Continue=6 Solve=4 Stop=3 | At enrollment |
| Number of participant with treatment-related advere events as assessed by... | From enrollment to the end of tretment at 8 weeks | |
| Participant retention- Completion rates | >75% continue, 50-75% Solve, <50% stop | The end of the 8- week program |
| Program Adherence | Continue >75%, solve 50-75%, stop <50% | The end of the 8-week program |
| Patients' self-perceived relevance, timing and mode of delivery | Patient evaluation, satisfied patients | >70% Continue, Solve 50-70%, Stop <50% |
| Assessment procedure acceptance- Patient evaluations, proportions of completed questionnaires | >80% continue, 50-80% solve, <50% stop | At the end of the 8-week program |
| Fidelity of delivery - Process evaluations | End of the 8-week program |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gunilla Stenberg, Docent | Contact | +46 90 7869895 | gunilla.stenberg@umu.se | |
| Sofia Björkbacka, MSc | Contact | 0046907869349 | sofia.bjorkbacka@umu.se |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inst. Community Medicine and Rehabilitation | Umeå | 90736 | Sweden |
To small intervention group and to big risk of exposing anonymity
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D059350 | Chronic Pain |
| D009437 | Neuralgia |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| Promobilia Foundation |
| OTHER |
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|
|
| D014947 | Wounds and Injuries |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |