search
Back to results

Exposure Therapy Combined With Cortical Interventions for CRPS-II (ETHICS)

Primary Purpose

Complex Regional Pain Syndromes

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Exposure therapy
Sponsored by
Uppsala University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Complex Regional Pain Syndromes focused on measuring Behavioural therapy, Exposure in vivo, Cortical reorganisation, Mirror therapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Complex regional pain syndrome II

Exclusion Criteria:

  • Severe psychiatric disorder drug abuse

Sites / Locations

  • Uppsala university hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Exposure therapy

Arm Description

Graded exposure therapy in vivo in combination with methods targeting cortical reorganisation.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

The Tampa Scale of Kinesiophobia - Short Form, TSK-SF
Fear of movement, assessed with a questionnaire

Full Information

First Posted
March 28, 2017
Last Updated
May 30, 2017
Sponsor
Uppsala University
Collaborators
Folksam
search

1. Study Identification

Unique Protocol Identification Number
NCT03174249
Brief Title
Exposure Therapy Combined With Cortical Interventions for CRPS-II
Acronym
ETHICS
Official Title
Leaving the Wheelchair Behind - Treating CRPS-II With Exposure Therapy Combined With Cortical Interventions: a Series of Case Reports
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
September 1, 2012 (Actual)
Primary Completion Date
June 1, 2015 (Actual)
Study Completion Date
June 1, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Uppsala University
Collaborators
Folksam

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complex Regional Pain Syndromes
Keywords
Behavioural therapy, Exposure in vivo, Cortical reorganisation, Mirror therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A series of case-studies
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exposure therapy
Arm Type
Experimental
Arm Description
Graded exposure therapy in vivo in combination with methods targeting cortical reorganisation.
Intervention Type
Behavioral
Intervention Name(s)
Exposure therapy
Other Intervention Name(s)
Mirror therapy, Desensibilisation training, Sensory re-education
Intervention Description
Daily training at an in-patient ward during four plus four weeks, separated by a home training period of 6-8 weeks.
Primary Outcome Measure Information:
Title
Photograph series of daily activities, PHODA
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
The Tampa Scale of Kinesiophobia - Short Form, TSK-SF
Description
Fear of movement, assessed with a questionnaire
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Complex regional pain syndrome II Exclusion Criteria: Severe psychiatric disorder drug abuse
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Torsten Gordh, PhD
Organizational Affiliation
Uppsala University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Uppsala university hospital
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Exposure Therapy Combined With Cortical Interventions for CRPS-II

We'll reach out to this number within 24 hrs