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Graded Exposure (GEXP) in Vivo Versus Physiotherapy in Complex Regional Pain Syndrome Type I (CRPS-I)
This study is not yet open for participant recruitment.
Verified by Maastricht University Medical Center, April 2008
First Received: February 21, 2008   Last Updated: April 21, 2008   History of Changes
Sponsor: Maastricht University Medical Center
Information provided by: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT00625976
  Purpose

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.


Condition Intervention
Complex Regional Pain Syndrome Type I
 Behavioral: Graded exposure in vivo
Behavioral: Physiotherapy

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Complex Regional Pain Syndrome
U.S. FDA Resources

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • 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 [ Time Frame: 2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Physical activity in daily life [ Time Frame: 2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up ] [ Designated as safety issue: No ]
  • Body function and structure [ Time Frame: 2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up ] [ Designated as safety issue: No ]
  • Fear of movement [ Time Frame: 2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up ] [ Designated as safety issue: No ]
  • Fear of pain [ Time Frame: 2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up ] [ Designated as safety issue: No ]
  • Catastrophizing Scale [ Time Frame: 2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up ] [ Designated as safety issue: No ]
  • Coping with pain [ Time Frame: 2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up ] [ Designated as safety issue: No ]
  • Emotional distress [ Time Frame: 2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up ] [ Designated as safety issue: No ]
  • Participation [ Time Frame: 2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up ] [ Designated as safety issue: No ]
  • Emotional involvement [ Time Frame: 2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 110
Study Start Date: May 2008
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Behavioral: Graded exposure in vivo
Graded exposure in vivo according to the protocol of de Jong et al. (2005)
2: Experimental Behavioral: Physiotherapy
Physiotherapy according to the protocol of Oerlemans, Oostendorp, de Boo and Goris (1999)

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00625976

Contacts
Contact: Tim Gard, M.Sc. +31 43 3881594 T.Gard@dmkep.unimaas.nl
Contact: Marielle Goossens, Dr. +31 43 3881477 M.Goossens@dep.unimaas.nl

Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Principal Investigator: Marielle Goossens, Dr. Maastricht University Medical Center
  More Information

No publications provided

Responsible Party: Maastricht University ( Dr. M. Goossens )
Study ID Numbers: MEC 08-3-004, NL20067.068.08
Study First Received: February 21, 2008
Last Updated: April 21, 2008
ClinicalTrials.gov Identifier: NCT00625976     History of Changes
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
Complex regional pain syndrome type I
Graded exposure in vivo
Physiotherapy
Pain-related fear

Additional relevant MeSH terms:
Pathologic Processes
Disease
Autonomic Nervous System Diseases
Reflex Sympathetic Dystrophy
Neuromuscular Diseases
Complex Regional Pain Syndromes
 Mental Disorders
Peripheral Nervous System Diseases
Syndrome
Nervous System Diseases
Somatoform Disorders

ClinicalTrials.gov processed this record on November 27, 2009



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