Treatment of Complex Regional Pain Syndrome, a Long-term Follow-up

Completed

• Conditions: Chronic Pain; Complex Regional Pain Syndromes

• Registration Number: NCT04597866
• Lead Sponsor: Uppsala University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-15
• Study Start: 2020-09-21
• Study First Submitted QC: 2020-10-16
• Study First Posted: 2020-10-22
• Primary Completion: 2021-06-30
• Study Completion: 2021-12-31
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-27
• Last Update Posted: 2024-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Has participated in multimodal treatment for CRPS at Uppsala University Hospital

Exclusion Criteria

• Other serious physical or mental condition

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnosis	1 day	Whether the subject still fulfill diagnostic criteria for CRPS
Subjective experience	1 day	A qualitative interview targeting the subjects own experience of the treatment and its effect

Secondary Outcome Measures

Name	Time	Method
Acceptance of pain	1 day (0-156, higher scores mean a better outcome)	Measured with the Chronic Pain Acceptance Questionnaire, CPAQ (0-156, higher scores mean a better outcome)
Level of pain	1 day	Subjective level of pain on a Likert-scale 0-10 (NRS)
Fear of pain	1 day (0-52, lower scores mean a better outcome)	Measured with the Tampa Scale of Kinesiophobia, TSK (0-52, lower scores mean a better outcome)
Subjective experience of quality of life 3	1 day	Life Satisfaction Questionnaire, LiSat 11 (11-66, higher scores means a better outcome)
Neglect of the affected limb	1 day (0-36, lower scores mean a better outcome)	Measured with a five item questionnaire (0-36, lower scores mean a better outcome)
Subjective experience of quality of life	1 day	Quality of life, measured with the RAND-36 (0-100, higher scores mean a better outcome)
Global impression of change	1 day	Global impression of change measured with a single question (0-6, higher scores mean a better outcome)
Pain catastrophizing	1 day (0-52, lower scores mean a better outcome)	Measured with Pain Catastrophizing Scale, PCS (0-52, lower scores mean a better outcome)
Avoidance of activities	1 day (0-100, lower scores mean a better outcome)	Measured with the Photograph Series of Daily Activities, PHODA (0-100, lower scores mean a better outcome)
Subjective experience of quality of life 2	1 day	EuroQol 5D, EQ-5D (0-15, higher scores means a better outcome)

Trial Locations

Locations (1)

Uppsala University; 🇸🇪 Uppsala, Sweden