Spinal Cord InjuriesNCT07634796
Development of a Pain Rehabilitation Program for Chronic Pain After SCI
A study testing multi-modality pain management in people with Spinal Cord Injuries and Chronic Pain, run by Umeå University at 1 site in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries, Chronic Pain, Neuropathic Pain
- What is being tested?
- multi-modality pain management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSweden
- Study dates
- 1 Oct 2026to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- two years since injury
- Stable pain medication?
Who cannot join
- severe cognitive impairment
- Alcohol or drug abuse
- does not understand Swedish
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Spinal Cord Injuries, Chronic Pain, Neuropathic Pain, Interprofessional Team Collaboration, Pain Management
- Being tested
- multi-modality pain management
- Keywords
- participatory design, feasibility study
- Medical subject headings
- Spinal Cord Injuries, Chronic Pain, Neuralgia, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multi-modality pain managementOther
Also called digital pain rehabilitation
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.
| Study group | Role | What they receive |
|---|---|---|
| Spinal cord injury (SCI) and chronic pain | Experimental | People with chronic pain after spinal cord injury Receives: Other: multi-modality pain management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate, number recruited per quarter
Continue=6 Solve=4 Stop=3
Measured: At enrollment
Number of participant with treatment-related advere events as assessed by...
Measured: From enrollment to the end of tretment at 8 weeks
Participant retention- Completion rates
>75% continue, 50-75% Solve, <50% stop
Measured: The end of the 8- week program
Program Adherence
Continue >75%, solve 50-75%, stop <50%
Measured: The end of the 8-week program
Patients' self-perceived relevance, timing and mode of delivery
Patient evaluation, satisfied patients
Measured: >70% Continue, Solve 50-70%, Stop <50%
Assessment procedure acceptance- Patient evaluations, proportions of completed questionnaires
>80% continue, 50-80% solve, <50% stop
Measured: At the end of the 8-week program
Fidelity of delivery - Process evaluations
Measured: End of the 8-week program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start1 Oct 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Collaborators
- Region Västerbotten, Riksförbundet för Trafik, Olycksfall och Polioskadade (RTP), Sundbyberg, Sweden, Norrbacka-Eugenia Foundation, Promobilia Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07634796
- Sponsor's protocol ID
- 2023-04232-01
- Other IDs
- 2023
- Status last verified
- Mar 2026
- First submitted
- 2 Jun 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To small intervention group and to big risk of exposing anonymity
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a New Digital Pain Rehabilitation Program for People With SCI
- ClinicalTrials.gov ID
- NCT07634796
- Acronym / sponsor ID
- 2023-04232-01
- Conditions
- Spinal Cord Injuries, Chronic Pain, Neuropathic Pain, Interprofessional Team Collaboration, Pain Management
- Keywords
- participatory design, feasibility study
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Collaborators
- Region Västerbotten, Riksförbundet för Trafik, Olycksfall och Polioskadade (RTP), Sundbyberg, Sweden, Norrbacka-Eugenia Foundation, Promobilia Foundation
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 9 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spinal cord injury (SCI) and chronic pain | Experimental | Other: multi-modality pain managementPeople with chronic pain after spinal cord injury |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- two years since injury
- Stable pain medication?
Key exclusion criteria (3 listed)
- severe cognitive impairment
- Alcohol or drug abuse
- does not understand Swedish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| multi-modality pain managementAlso: digital pain rehabilitation8- 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. | Other | Spinal cord injury (SCI) and chronic pain |
Primary outcome
Recruitment rate, number recruited per quarter
Time frame: At enrollment
Continue=6 Solve=4 Stop=3
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
>75% continue, 50-75% Solve, <50% stop
Program Adherence
Time frame: The end of the 8-week program
Continue >75%, solve 50-75%, stop <50%
Patients' self-perceived relevance, timing and mode of delivery
Time frame: >70% Continue, Solve 50-70%, Stop <50%
Patient evaluation, satisfied patients
Assessment procedure acceptance- Patient evaluations, proportions of completed questionnaires
Time frame: At the end of the 8-week program
>80% continue, 50-80% solve, <50% stop
Fidelity of delivery - Process evaluations
Time frame: End of the 8-week program
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Individual participant dataSharing planned: No. To small intervention group and to big risk of exposing anonymity
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing multi-modality pain management in people with Spinal Cord Injuries and Chronic Pain, run by Umeå University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gunilla Stenberg, Docent (+46 90 7869895, gunilla.stenberg@umu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate, number recruited per quarter (time frame: At enrollment). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.