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CompletedNCT03174249ETHICSUpdated Jun 2, 2017

Exposure Therapy Combined With Cortical Interventions for CRPS-II

An interventional study of Exposure therapy in Complex Regional Pain Syndromes, sponsored by Uppsala University. Completed at 1 site in Sweden. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-06-02.

Sponsored by Uppsala University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 4 years 6 months after the study started (first participant enrolled Sep 2012, registered Mar 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
4
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Complex Regional Pain Syndromes

Keywords

  • Behavioural therapy
  • Exposure in vivo
  • Cortical reorganisation
  • Mirror therapy
03

In context

Complex Regional Pain Syndromes

198 studies on the registry are indexed under Complex Regional Pain Syndromes; 55 are open to participants now.

This study's enrollment of 4 is below the median of 40 across 146 interventional studies indexed under Complex Regional Pain Syndromes.

Browse Complex Regional Pain Syndromes studies →

Lead sponsor

Uppsala University is the lead sponsor of 381 studies on the registry; 84 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Complex regional pain syndrome II

Exclusion criteria

Exclusion Criteria:

  • Severe psychiatric disorder drug abuse
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
4 participants (actual)

Study arms

  • Experimental
    Exposure therapy

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

    Behavioral: Exposure therapy

Interventions

  • BehavioralExposure therapy

    Daily training at an in-patient ward during four plus four weeks, separated by a home training period of 6-8 weeks.

    Also known as: Mirror therapy, Desensibilisation training, Sensory re-education

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 12 weeks

Secondary outcomes

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

    Fear of movement, assessed with a questionnaire

    Time frame: 12 weeks

07

Study locations

1 site
  • Uppsala university hospital
    Uppsala, 751 85, Sweden
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 2, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03174249
Lead sponsor
Uppsala University
Collaborators
Folksam
Responsible party
Sponsor
First posted
Jun 2, 2017
Start date
Sep 1, 2012
Primary completion
Jun 1, 2015
Completion
Jun 1, 2015
Last update
Jun 2, 2017

Study contacts

Torsten Gordh, PhD
principal investigator · Uppsala University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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