Exposure Therapy Combined With Cortical Interventions for CRPS-II (ETHICS)
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|ClinicalTrials.gov Identifier: NCT03174249|
Recruitment Status : Completed
First Posted : June 2, 2017
Last Update Posted : June 2, 2017
|Condition or disease||Intervention/treatment||Phase|
|Complex Regional Pain Syndromes||Behavioral: Exposure therapy||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||A series of case-studies|
|Masking:||None (Open Label)|
|Official Title:||Leaving the Wheelchair Behind - Treating CRPS-II With Exposure Therapy Combined With Cortical Interventions: a Series of Case Reports|
|Actual Study Start Date :||September 1, 2012|
|Actual Primary Completion Date :||June 1, 2015|
|Actual Study Completion Date :||June 1, 2015|
Experimental: Exposure therapy
Graded exposure therapy in vivo in combination with methods targeting cortical reorganisation.
Behavioral: Exposure therapy
Daily training at an in-patient ward during four plus four weeks, separated by a home training period of 6-8 weeks.
- Photograph series of daily activities, PHODA [ Time Frame: 12 weeks ]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.
- The Tampa Scale of Kinesiophobia - Short Form, TSK-SF [ Time Frame: 12 weeks ]Fear of movement, assessed with a questionnaire
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03174249
|Uppsala university hospital|
|Uppsala, Sweden, 751 85|
|Principal Investigator:||Torsten Gordh, PhD||Uppsala University|