Clinical trial NCT00625976: Graded Exposure (GEXP) in Vivo Versus Physiotherapy in Complex Regional Pain Syndrome Type I (CRPS-I)
Official title: The Effectivity of Graded Exposure in Vivo Versus Standardized Physiotherapy in Complex Regional Pain Syndrome Type I (CRPS-I) Patients With Pain Related Fear: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Complex Regional Pain Syndrome Type I
Keywords: Complex regional pain syndrome type I
Graded exposure in vivo
Physiotherapy
Pain-related fear
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2008-02-29
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Functional disability measured with: Radboud Skills Questionnaire (RASQ; Oerlemans, Cup et al., 2000), for upper limbs; Walking Ability Questionnaire (WAQ; Perez et al., 2002), for lower limbs
timeFrame: 2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up
Secondary outcomes:
measure: Physical activity in daily life
timeFrame: 2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up
measure: Body function and structure
timeFrame: 2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up
measure: Fear of movement
timeFrame: 2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up
measure: Fear of pain
timeFrame: 2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up
measure: Catastrophizing Scale
timeFrame: 2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up
measure: Coping with pain
timeFrame: 2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up
measure: Emotional distress
timeFrame: 2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up
measure: Participation
timeFrame: 2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up
measure: Emotional involvement
timeFrame: 2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up
Other outcomes:
Locations:
Study officials:
affiliation: Maastricht University
name: Marielle Goossens, Dr.
role: PRINCIPAL_INVESTIGATOR
References: