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

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

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.

Study Overview

• Status: Completed
• Conditions: Complex Regional Pain Syndrome Type I
• Intervention / Treatment: Behavioral: Graded exposure in vivo; Behavioral: Physiotherapy

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Behavioral: Graded exposure in vivo; Graded exposure in vivo according to the protocol of de Jong et al. (2005)
Experimental: 2	Behavioral: Physiotherapy; Physiotherapy according to the protocol of Oerlemans, Oostendorp, de Boo and Goris (1999)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
Physical activity in daily life	2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up
Body function and structure	2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up
Fear of movement	2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up
Fear of pain	2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up
Catastrophizing Scale	2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up
Coping with pain	2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up
Emotional distress	2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up
Participation	2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up
Emotional involvement	2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center
• Investigators: Principal Investigator: Marielle Goossens, Dr., Maastricht University

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: February 21, 2008
• First Submitted That Met QC Criteria: February 28, 2008
• First Posted (Estimate): February 29, 2008

Study Record Updates

• Last Update Posted (Estimate): September 19, 2014
• Last Update Submitted That Met QC Criteria: September 18, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: Physiotherapy; Complex regional pain syndrome type I; Graded exposure in vivo; Pain-related fear
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Disease; Neuromuscular Diseases; Peripheral Nervous System Diseases; Autonomic Nervous System Diseases; Syndrome; Complex Regional Pain Syndromes; Reflex Sympathetic Dystrophy; Somatoform Disorders
• Other Study ID Numbers: MEC 08-3-004; NL20067.068.08