Development of a Pain Rehabilitation Program for Chronic Pain After SCI
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: multi-modality pain management.
- Who it may be relevant to
- Registry conditions: Spinal Cord Injuries, Chronic Pain, Neuropathic Pain, Interprofessional Team Collaboration. 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
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Feasibility of a New Digital Pain Rehabilitation Program for People With SCI
Overview
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.
Detailed description
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.
Interventions
- Other 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
Primary outcome measures
- Recruitment rate, number recruited per quarter [Time frame: At enrollment]
- Number of participant with treatment-related advere events as assessed by... [Time frame: From enrollment to the end of tretment at 8 weeks]
- Participant retention- Completion rates [Time frame: The end of the 8- week program]
- Program Adherence [Time frame: The end of the 8-week program]
- Patients' self-perceived relevance, timing and mode of delivery [Time frame: >70% Continue, Solve 50-70%, Stop <50%]
- Assessment procedure acceptance- Patient evaluations, proportions of completed questionnaires [Time frame: At the end of the 8-week program]
- Fidelity of delivery - Process evaluations [Time frame: End of the 8-week program]
Eligibility criteria
Inclusion criteria
- two years since injury
- Stable pain medication?
Exclusion criteria
- severe cognitive impairment
- Alcohol or drug abuse
- does not understand Swedish
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Sweden · 1 center
- Inst. Community Medicine and Rehabilitation — Umeå
Identifiers
NCT: NCT07634796 · 2023-04232-01