Exposure Therapy Combined With Cortical Interventions for CRPS-II

Study Overview
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Brief Summary
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Consecutive patients with long-standing complex regional pain syndrome II in a lower limb are treated with graded exposure therapy in vivo in combination with methods targeting cortical reorganisation.

Detailed Description
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Complex regional pain syndrome, CRPS, is an uncommon but often very handicapping chronic pain syndrome. Most often, a single extremity is affected. The diagnosis is subdivided in CRPS type I where no nerve injury has been identified, and CRPS type II when a major nerve injury has been verified. With the exception of spontaneous pain, several of the symptoms related to CRPS may be connected to the inactivity and immobilization often seen in the history of CRPS patients. Exposure in vivo, a form of behaviour therapy where the patient is gradually confronted with the avoided movements and activities, has been shown safe and effective for patients with CRPS type I. The present study uses a combination of exposure in vivo and interventions targeting a supposed cortical reorganisation with the hypothesis that the functional impairments would decrease, independent of possible changes in pain levels. Consecutive patients with long-standing CRPS-II, diagnosed according to the Budapest criteria, in a lower limb are included. Treatment comprises daily graded exposure therapy in vivo, in combination with methods targeting cortical reorganisation: mirror therapy, desensibilisation training, and sensory re-education. The treatment is implemented at an in-patient ward during four plus four weeks, separated by a home training period of 6-8 weeks.

Official Title
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Leaving the Wheelchair Behind - Treating CRPS-II With Exposure Therapy Combined With Cortical Interventions: a Series of Case Reports

Conditions
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Complex Regional Pain Syndromes

Intervention / Treatment
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* Behavioral: Exposure therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Complex regional pain syndrome II Exclusion Criteria: Severe psychiatric disorder drug abuse

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: A series of case-studies
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exposure therapy<br>Graded exposure therapy in vivo in combination with methods targeting cortical reorganisation. | Behavioral: Exposure therapy<br>* Daily training at an in-patient ward during four plus four weeks, separated by a home training period of 6-8 weeks.<br>* Other names: Sensory re-education;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Photograph series of daily activities, PHODA | A measure of avoidance of activities - the subject reports level of hesitation in performing a number of everyday activities on a 0-100 rating scale. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Tampa Scale of Kinesiophobia - Short Form, TSK-SF | Fear of movement, assessed with a questionnaire | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Behavioural therapy, Exposure in vivo, Cortical reorganisation, Mirror therapy