Graded Exposure (GEXP) in Vivo Versus Physiotherapy in Complex Regional Pain Syndrome Type I (CRPS-I)

NCT ID: NCT00625976

Last Updated: 2014-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2014-09-30

Brief Summary

Background:

Research on the treatment of CRPS-I, as described in the Dutch evidence based treatment guidelines (Richtlijn Complex Regional Pain Syndrome type I, 2006), mainly showed improvement at the level of pain and coping with pain. Only little improvement in functional restoration was found. Research in other pain populations such al neck- and back-pain patients has shown that pain related fear contributes to the development of functional disability. GEXP in vivo which aims on systematically reducing fear of movement, shows promising results in CRPS-I patients (de Jong et al., 2005).

Objective:

The objective of the proposed project is to compare the effectivity of GEXP in vivo with that of standardized physiotherapy in CRPS-I patients with pain related fear.

Design:

The study concerns a single blinded, single center, randomized clinical trial. The treatment will be preceded by two pre-measures. After treatment there will be one post-measurement and 3, 6 and 12 month follow-up measurements.

Population:

The study population will consist of chronic CRPS-I patients between 18 and 65, with pain related fear (PHODA-LE-score ≥ 35 and PHODA-UE-score ≥ 32).

Intervention:

The two interventions that will be compared are GEXP in vivo (de Jong et al., 2005) and standardized physiotherapy according to the protocol of Oerlemans, Oostendorp, de Boo en Goris (1999). The GEXP in vivo comprises 17 sessions of one hour, the physiotherapy treatment of 34 sessions of 30 minutes. Both treatments will be given over a period of 17 weeks.

Conditions

Complex Regional Pain Syndrome Type I

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

Group Type: EXPERIMENTAL

Graded exposure in vivo

Intervention Type: BEHAVIORAL

Graded exposure in vivo according to the protocol of de Jong et al. (2005)

2

Group Type: EXPERIMENTAL

Physiotherapy

Intervention Type: BEHAVIORAL

Physiotherapy according to the protocol of Oerlemans, Oostendorp, de Boo and Goris (1999)

Interventions

Graded exposure in vivo

Graded exposure in vivo according to the protocol of de Jong et al. (2005)

Intervention Type: BEHAVIORAL

Physiotherapy

Physiotherapy according to the protocol of Oerlemans, Oostendorp, de Boo and Goris (1999)

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Diagnosis CRPS-I according to IASP criteria.

2. Pain related (PHODA-LE-score ≥ 35 and PHODA-UE-score ≥ 32)

3. Age between 18 and 65.

4. Rehabilitation treatment has been indicated.

Exclusion Criteria

1. Pregnancy.

2. Insufficient fluency in Dutch.

3. Generalized pain syndrome.

4. Dystonia.

5. Sympathectomy of the affected extremity.

6. Psychopathology

7. Involvement in a claim regarding the disease.

8. Substance abuse.

9. Symptoms on both upper or both lower extremities.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marielle Goossens, Dr.

Role: PRINCIPAL_INVESTIGATOR

Maastricht University

Other Identifiers

NL20067.068.08

Identifier Type: -

Identifier Source: secondary_id

MEC 08-3-004

Identifier Type: -

Identifier Source: org_study_id