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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
Sponsor:
Collaborator:
Folksam
Information provided by (Responsible Party):
Uppsala University

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
Complex Regional Pain Syndromes Behavioral: Exposure therapy Not Applicable

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.


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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)
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 : September 1, 2012
Actual Primary Completion Date : June 1, 2015
Actual Study Completion Date : June 1, 2015

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. The Tampa Scale of Kinesiophobia - Short Form, TSK-SF [ Time Frame: 12 weeks ]
    Fear of movement, assessed with a questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Complex regional pain syndrome II

Exclusion Criteria:

  • Severe psychiatric disorder drug abuse

Information from the National Library of Medicine

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


Locations
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Sweden
Uppsala university hospital
Uppsala, Sweden, 751 85
Sponsors and Collaborators
Uppsala University
Folksam
Investigators
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Principal Investigator: Torsten Gordh, PhD Uppsala University

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Responsible Party: Uppsala University
ClinicalTrials.gov Identifier: NCT03174249     History of Changes
Other Study ID Numbers: FF-S23
First Posted: June 2, 2017    Key Record Dates
Last Update Posted: June 2, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Complex Regional Pain Syndromes
Reflex Sympathetic Dystrophy
Autonomic Nervous System Diseases
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases