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Completed

NCT Number: NCT03174249

Exposure Therapy Combined With Cortical Interventions for CRPS-II

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.

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Key information

Conditions

Complex Regional Pain Syndromes Autonomic Nervous System Diseases Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Uppsala university hospital

Uppsala, 751 85, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Complex regional pain syndrome II

Exclusion criteria

  • Severe psychiatric disorder drug abuse

Treatment and study plan

Exposure Therapy

Behavioral

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 outcomes

  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 outcomes

  1. The Tampa Scale of Kinesiophobia - Short Form, TSK-SF

    Time frame: 12 weeks

    Fear of movement, assessed with a questionnaire

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Collaborators

  • Folksam

Registry information

Official study title

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

Acronym: ETHICS

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jun 2, 2017
Registry last updated
Jun 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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