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

Complex Regional Pain Syndrome Type I Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00625976
• Other study ID #: MEC 08-3-004
• Secondary ID: NL20067.068.08
• Status: Completed
• Phase: N/A
• First received: February 21, 2008
• Last updated: September 18, 2014
• Start date: May 2008
• Est. completion date: September 2014

Study information

• Verified date: September 2014
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: September 2014
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Complex Regional Pain Syndrome Type I
• Complex Regional Pain Syndromes
• Reflex Sympathetic Dystrophy
• Somatoform Disorders
• Syndrome

Intervention

Behavioral:
• Graded exposure in vivo
Graded exposure in vivo according to the protocol of de Jong et al. (2005)
• Physiotherapy
Physiotherapy according to the protocol of Oerlemans, Oostendorp, de Boo and Goris (1999)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up	No
Secondary	Physical activity in daily life		2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up	No
Secondary	Body function and structure		2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up	No
Secondary	Fear of movement		2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up	No
Secondary	Fear of pain		2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up	No
Secondary	Catastrophizing Scale		2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up	No
Secondary	Coping with pain		2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up	No
Secondary	Emotional distress		2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up	No
Secondary	Participation		2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up	No
Secondary	Emotional involvement		2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up	No