Development of a Pain Rehabilitation Program for Chronic Pain After SCI

June 2, 2026 updated by: Umeå University

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:

  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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Sweden
      • Umeå, Sweden, 90736
        • Inst. Community Medicine and Rehabilitation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • two years since injury
  • Stable pain medication?

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Spinal cord injury (SCI) and chronic pain
People with chronic pain after spinal cord injury
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 discussions led by clinicians with long experience in pain rehabilitation and SCI.
Other Names:
  • digital pain rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment rate, number recruited per quarter
Time Frame: At enrollment
Continue=6 Solve=4 Stop=3
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
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
The end of the 8- week program
Program Adherence
Time Frame: The end of the 8-week program
Continue >75%, solve 50-75%, stop <50%
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%
Patient evaluation, satisfied patients
>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
>80% continue, 50-80% solve, <50% stop
At the end of the 8-week program
Fidelity of delivery - Process evaluations
Time Frame: End of the 8-week program
End of the 8-week program

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Umeå University

Collaborators

Norrbacka-Eugenia Foundation
Region Västerbotten
Promobilia Foundation
Riksförbundet för Trafik, Olycksfall och Polioskadade (RTP), Sundbyberg, Sweden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

June 2, 2026

First Submitted That Met QC Criteria

June 2, 2026

First Posted (Actual)

June 9, 2026

Study Record Updates

Last Update Posted (Actual)

June 9, 2026

Last Update Submitted That Met QC Criteria

June 2, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-04232-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

To small intervention group and to big risk of exposing anonymity

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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