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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

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

NCT ID

NCT03174249

First Posted

March 28, 2017

Last Updated

May 30, 2017

Sponsor

Uppsala University

Collaborators

Folksam

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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

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

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

Learn more about this trial

Exposure Therapy Combined With Cortical Interventions for CRPS-II

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