Exposure Therapy Combined With Cortical Interventions for CRPS-II

Complex Regional Pain Syndromes Clinical Trial

— ETHICS  

Official title:

Leaving the Wheelchair Behind - Treating CRPS-II With Exposure Therapy Combined With Cortical Interventions: a Series of Case Reports

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03174249
• Other study ID #: FF-S23
• Status: Completed
• Phase: N/A
• First received: March 28, 2017
• Last updated: May 30, 2017
• Start date: September 1, 2012
• Est. completion date: June 1, 2015

Study information

• Verified date: May 2017
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: June 1, 2015
• Est. primary completion date: June 1, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Complex regional pain syndrome II

Exclusion Criteria:

• Severe psychiatric disorder drug abuse

Related Conditions & MeSH terms

• Complex Regional Pain Syndromes
• Reflex Sympathetic Dystrophy

Intervention

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.

Locations

Country	Name	City	State
Sweden	Uppsala university hospital	Uppsala

Sponsors (2)

Lead Sponsor	Collaborator
Uppsala University	Folksam

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 weeks
Secondary	The Tampa Scale of Kinesiophobia - Short Form, TSK-SF	Fear of movement, assessed with a questionnaire	12 weeks