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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.
Study NCT00625976   Information provided by Maastricht University Medical Center
First Received: February 21, 2008   Last Updated: April 21, 2008   History of Changes

February 21, 2008
April 21, 2008
May 2008
July 2011   (final data collection date for primary outcome 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 [ Time Frame: 2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00625976 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
 
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.

 
 
Interventional
Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Complex Regional Pain Syndrome Type I
  • Behavioral: Graded exposure in vivo
  • Behavioral: Physiotherapy
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Not yet recruiting
110
September 2011
July 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
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
 
 
NCT00625976
Dr. M. Goossens, Maastricht University
MEC 08-3-004, NL20067.068.08
Maastricht University Medical Center
 
Principal Investigator: Marielle Goossens, Dr. Maastricht University Medical Center
Maastricht University Medical Center
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP