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

Maastricht University Medical Centre (MUMC)

Status: Completed

Conditions: Complex Regional Pain Syndrome Type I

Treatments: Behavioral: Physiotherapy; Behavioral: Graded exposure in vivo

Study type: Interventional

Funder types: Other

Identifiers

NCT00625976

MEC 08-3-004

NL20067.068.08

Details and patient eligibility

About

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.

Enrollment: 46 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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46 participants in 2 patient groups

1

Experimental group

Treatment:

Behavioral: Graded exposure in vivo

2

Experimental group

Treatment:

Behavioral: Physiotherapy