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ETHICS: Exposure Therapy Combined With Cortical Interventions for CRPS-II

Sponsor
Uppsala University (Other)
Overall Status
Completed
CT.gov ID
NCT03174249
Collaborator
Folksam (Other)
4
Enrollment
1
Location
1
Arm
33
Actual Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Exposure therapy
 N/A

Detailed Description

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 Design

Study Type:
Interventional
Actual Enrollment :
4 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
A series of case-studiesA series of case-studies
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 :
Sep 1, 2012
Actual Primary Completion Date :
Jun 1, 2015
Actual Study Completion Date :
Jun 1, 2015

Arms and Interventions

Arm Intervention/Treatment
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.
Other Names:
  • Mirror therapy
  • Desensibilisation training
  • Sensory re-education

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Photograph series of daily activities, PHODA [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.

    Secondary Outcome Measures

    1. The Tampa Scale of Kinesiophobia - Short Form, TSK-SF [12 weeks]

      Fear of movement, assessed with a questionnaire

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Complex regional pain syndrome II
    Exclusion Criteria:
    • Severe psychiatric disorder drug abuse

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Uppsala university hospital Uppsala Sweden 751 85

    Sponsors and Collaborators

    • Uppsala University
    • Folksam

    Investigators

    • Principal Investigator: Torsten Gordh, PhD, Uppsala University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Uppsala University
    ClinicalTrials.gov Identifier:
    NCT03174249
    Other Study ID Numbers:
    • FF-S23
    First Posted:
    Jun 2, 2017
    Last Update Posted:
    Jun 2, 2017
    Last Verified:
    May 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Uppsala University
    Behavioural therapy
    Exposure in vivo
    Cortical reorganisation
    Mirror therapy
    Additional relevant MeSH terms:
    Complex Regional Pain Syndromes
    Reflex Sympathetic Dystrophy

    Study Results

    No Results Posted as of Jun 2, 2017