Treatment of Complex Regional Pain Syndrome, a Long-term Follow-up
TORNADO
1 other identifier
observational
10
1 country
1
Brief Summary
Complex regional pain syndrome, CRPS, is an uncommon but often very disabling chronic pain syndrome characterized by, beside pain: sensory disturbances, peripheral autonomic changes and inflammatory features. The diagnosis is subdivided in CRPS type 1 where no nerve injury has been identified, and CRPS type 2 when a major nerve injury has been verified. A combination of exposure in vivo, a form of behaviour therapy where the patient is gradually confronted with avoided movements and activities, and interventions directly targeting a hypothesized cortical reorganisation is an interesting novel approach for treating CRPS. The present study consists of (1) a qualitative interview study with 10-15 subjects that has received this form of treatment, in order to better understand their experience and effects of the treatment, and (2) a case series with long-term follow-up of 3-5 subjects that received the treatment för 5-8 years ago, in order to study the long term effects of the treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Sep 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 15, 2020
CompletedStudy Start
First participant enrolled
September 21, 2020
CompletedFirst Posted
Study publicly available on registry
October 22, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedFebruary 28, 2024
February 1, 2024
9 months
September 15, 2020
February 27, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Diagnosis
Whether the subject still fulfill diagnostic criteria for CRPS
1 day
Subjective experience
A qualitative interview targeting the subjects own experience of the treatment and its effect
1 day
Secondary Outcomes (10)
Level of pain
1 day
Subjective experience of quality of life
1 day
Global impression of change
1 day
Acceptance of pain
1 day (0-156, higher scores mean a better outcome)
Fear of pain
1 day (0-52, lower scores mean a better outcome)
- +5 more secondary outcomes
Study Arms (1)
CRPS
Interventions
A combination of exposure in vivo and interventions directly targeting the cortical reorganization for treating CRPS.
Eligibility Criteria
Subjects with CRPS 1 or 2, diagnosed according to the Budapest criteria that has received in-patient treatment at Uppsala University Hospital, comprised of graded exposure therapy in vivo, in combination with methods targeting cortical reorganisation.
You may qualify if:
- Has participated in multimodal treatment for CRPS at Uppsala University Hospital
You may not qualify if:
- Other serious physical or mental condition
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Uppsala University
Uppsala, 75185, Sweden
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kristoffer Bothelius, PhD
Uppsala University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 15, 2020
First Posted
October 22, 2020
Study Start
September 21, 2020
Primary Completion
June 30, 2021
Study Completion
December 31, 2021
Last Updated
February 28, 2024
Record last verified: 2024-02