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Not yet recruitingNCT07634796Updated Jun 9, 2026

Development of a Pain Rehabilitation Program for Chronic Pain After SCI

An interventional study of multi-modality pain management in Spinal Cord Injuries, Chronic Pain and Neuropathic Pain, sponsored by Umeå University. Not yet recruiting at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-09.

Sponsored by Umeå University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

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.
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.

02

Conditions studied

  • Spinal Cord Injuries
  • Chronic Pain
  • Neuropathic Pain
  • Interprofessional Team Collaboration
  • Pain Management

Keywords

  • participatory design
  • feasibility study
03

In context

Spinal Cord Injuries

2,025 studies on the registry are indexed under Spinal Cord Injuries; 537 are open to participants now.

This study's planned enrollment of 32 is above the median of 24 across 1,633 interventional studies indexed under Spinal Cord Injuries.

Browse Spinal Cord Injuries studies →

Lead sponsor

Umeå University is the lead sponsor of 272 studies on the registry; 60 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • two years since injury
  • Stable pain medication?

Exclusion criteria

Exclusion Criteria:

  • severe cognitive impairment
  • Alcohol or drug abuse
  • does not understand Swedish
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
32 participants (estimated)

Study arms

  • Experimental
    Spinal cord injury (SCI) and chronic pain

    People with chronic pain after spinal cord injury

    Other: multi-modality pain management

Interventions

  • Othermulti-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 discussions led by clinicians with long experience in pain rehabilitation and SCI.

    Also known as: digital pain rehabilitation

06

What researchers measure

Primary outcomes

  1. Recruitment rate, number recruited per quarter

    Continue=6 Solve=4 Stop=3

    Time frame: At enrollment

  2. Number of participant with treatment-related advere events as assessed by...

    Time frame: From enrollment to the end of tretment at 8 weeks

  3. Participant retention- Completion rates

    \>75% continue, 50-75% Solve, \<50% stop

    Time frame: The end of the 8- week program

  4. Program Adherence

    Continue \>75%, solve 50-75%, stop \<50%

    Time frame: The end of the 8-week program

  5. Patients' self-perceived relevance, timing and mode of delivery

    Patient evaluation, satisfied patients

    Time frame: >70% Continue, Solve 50-70%, Stop <50%

  6. Assessment procedure acceptance- Patient evaluations, proportions of completed questionnaires

    \>80% continue, 50-80% solve, \<50% stop

    Time frame: At the end of the 8-week program

  7. Fidelity of delivery - Process evaluations

    Time frame: End of the 8-week program

07

Study locations

1 site
  • Inst. Community Medicine and Rehabilitation
    Umeå, 90736, Sweden
08

References and documents

Individual participant data

Plan to share: No — To small intervention group and to big risk of exposing anonymity

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for Sep 2027, 11 months later.

Of 790 non-industry interventional studies with no phase under Spinal Cord Injuries, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 65. This study's planned 11 months is below that.

Counting every sponsor, half of 839 studies reached it within 36 months; a quarter within 17 and three quarters within 64.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 2, 2026
First posted
Jun 9, 2026
StartEst.
Oct 1, 2026
Primary completionEst.
Sep 2027
CompletionEst.
Sep 2027
Last update
Jun 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07634796
Lead sponsor
Umeå University
Collaborators
Region Västerbotten, Riksförbundet för Trafik, Olycksfall och Polioskadade (RTP), Sundbyberg, Sweden, Norrbacka-Eugenia Foundation, Promobilia Foundation
Responsible party
Sponsor
First posted
Jun 9, 2026
Start date
Oct 1, 2026 (estimated)
Primary completion
Sep 2027 (estimated)
Completion
Sep 2027 (estimated)
Last update
Jun 9, 2026

Study contacts

Gunilla Stenberg, Docent
Contact
gunilla.stenberg@umu.se
+46 90 7869895
Sofia Björkbacka, MSc
Contact
sofia.bjorkbacka@umu.se
0046907869349

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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