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

Chronic Pain Clinical Trial

— TORNADO  

Official title:

Treatment of Complex Regional Pain Syndrome, a Qualitative Interview Study and a Case Series With Long-term Follow-up

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04597866
• Other study ID #: 2020-03383
• Status: Completed
• Start date: September 21, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: February 2024
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 31, 2021
• Est. primary completion date: June 30, 2021
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Other serious physical or mental condition

Related Conditions & MeSH terms

• Chronic Pain
• Complex Regional Pain Syndromes
• Reflex Sympathetic Dystrophy
• Somatoform Disorders
• Syndrome

Intervention

Behavioral:
• Multimodal rehabilitation
A combination of exposure in vivo and interventions directly targeting the cortical reorganization for treating CRPS.

Locations

Country	Name	City	State
Sweden	Uppsala University	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnosis	Whether the subject still fulfill diagnostic criteria for CRPS	1 day
Primary	Subjective experience	A qualitative interview targeting the subjects own experience of the treatment and its effect	1 day
Secondary	Level of pain	Subjective level of pain on a Likert-scale 0-10 (NRS)	1 day
Secondary	Subjective experience of quality of life	Quality of life, measured with the RAND-36 (0-100, higher scores mean a better outcome)	1 day
Secondary	Global impression of change	Global impression of change measured with a single question (0-6, higher scores mean a better outcome)	1 day
Secondary	Acceptance of pain	Measured with the Chronic Pain Acceptance Questionnaire, CPAQ (0-156, higher scores mean a better outcome)	1 day (0-156, higher scores mean a better outcome)
Secondary	Fear of pain	Measured with the Tampa Scale of Kinesiophobia, TSK (0-52, lower scores mean a better outcome)	1 day (0-52, lower scores mean a better outcome)
Secondary	Pain catastrophizing	Measured with Pain Catastrophizing Scale, PCS (0-52, lower scores mean a better outcome)	1 day (0-52, lower scores mean a better outcome)
Secondary	Avoidance of activities	Measured with the Photograph Series of Daily Activities, PHODA (0-100, lower scores mean a better outcome)	1 day (0-100, lower scores mean a better outcome)
Secondary	Neglect of the affected limb	Measured with a five item questionnaire (0-36, lower scores mean a better outcome)	1 day (0-36, lower scores mean a better outcome)
Secondary	Subjective experience of quality of life 2	EuroQol 5D, EQ-5D (0-15, higher scores means a better outcome)	1 day
Secondary	Subjective experience of quality of life 3	Life Satisfaction Questionnaire, LiSat 11 (11-66, higher scores means a better outcome)	1 day