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NCT Number: NCT07634796

Development of a Pain Rehabilitation Program for Chronic Pain After 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.

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Key information

Conditions

Spinal Cord Injuries Agnosia Central Nervous System Diseases Chronic Pain Interprofessional Team Collaboration Nervous System Diseases Neuralgia Neurobehavioral Manifestations Neurologic Manifestations Neuromuscular Diseases Neuropathic Pain Pain Pain Management Pathological Conditions, Signs and Symptoms Perceptual Disorders Peripheral Nervous System Diseases Signs and Symptoms Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Inst. Community Medicine and Rehabilitation

Umeå, 90736, Sweden

About this 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • two years since injury
  • Stable pain medication?

Exclusion criteria

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

Treatment and study plan

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.

Other names: digital pain rehabilitation

Primary outcomes

  1. Recruitment rate, number recruited per quarter

    Time frame: At enrollment

    Continue=6 Solve=4 Stop=3

  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

    Time frame: The end of the 8- week program

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

  4. Program Adherence

    Time frame: The end of the 8-week program

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

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

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

    Patient evaluation, satisfied patients

  6. 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

  7. Fidelity of delivery - Process evaluations

    Time frame: End of the 8-week program

Study contacts

Contact information is provided by the study sponsor or research team.

Gunilla Stenberg, Docent

CONTACT

[email protected]

+46 90 7869895

Sofia Björkbacka, MSc

CONTACT

[email protected]

0046907869349

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Collaborators

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

Registry information

Official study title

Feasibility of a New Digital Pain Rehabilitation Program for People With SCI

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 9, 2026
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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