NCT07634796

Brief 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. 1.Develop a new digital pain rehabilitation program, adapted for the needs of people living with an SCI.
  2. 2.To investigate the feasibility and acceptability of a new digital pain rehabilitation program.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
11mo left

Started Oct 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 2, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 9, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2026

Expected
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

June 9, 2026

Status Verified

March 1, 2026

Enrollment Period

11 months

First QC Date

June 2, 2026

Last Update Submit

June 2, 2026

Conditions

Keywords

participatory designfeasibility study

Outcome Measures

Primary Outcomes (7)

  • Recruitment rate, number recruited per quarter

    Continue=6 Solve=4 Stop=3

    At enrollment

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

    From enrollment to the end of tretment at 8 weeks

  • Participant retention- Completion rates

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

    The end of the 8- week program

  • Program Adherence

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

    The end of the 8-week program

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

    Patient evaluation, satisfied patients

    >70% Continue, Solve 50-70%, Stop <50%

  • Assessment procedure acceptance- Patient evaluations, proportions of completed questionnaires

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

    At the end of the 8-week program

  • Fidelity of delivery - Process evaluations

    End of the 8-week program

Study Arms (1)

Spinal cord injury (SCI) and chronic pain

EXPERIMENTAL

People with chronic pain after spinal cord injury

Other: multi-modality pain management

Interventions

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
Spinal cord injury (SCI) and chronic pain

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • two years since injury
  • Stable pain medication?

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inst. Community Medicine and Rehabilitation

Umeå, 90736, Sweden

Location

MeSH Terms

Conditions

Spinal Cord InjuriesChronic PainNeuralgiaAgnosia

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPeripheral Nervous System DiseasesNeuromuscular DiseasesPerceptual DisordersNeurobehavioral Manifestations

Central Study Contacts

Gunilla Stenberg, Docent

CONTACT

Sofia Björkbacka, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2026

First Posted

June 9, 2026

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

June 9, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

To small intervention group and to big risk of exposing anonymity

Locations