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

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ClinicalTrials.gov Identifier: NCT00625976
Recruitment Status : Completed
First Posted : February 29, 2008
Last Update Posted : September 19, 2014
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center

Tracking Information
First Submitted Date  ICMJE February 21, 2008
First Posted Date  ICMJE February 29, 2008
Last Update Posted Date September 19, 2014
Study Start Date  ICMJE May 2008
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 28, 2008)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 28, 2008)
  • Physical activity in daily life [ Time Frame: 2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up ]
  • Body function and structure [ Time Frame: 2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up ]
  • Fear of movement [ Time Frame: 2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up ]
  • Fear of pain [ Time Frame: 2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up ]
  • Catastrophizing Scale [ Time Frame: 2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up ]
  • Coping with pain [ Time Frame: 2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up ]
  • Emotional distress [ Time Frame: 2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up ]
  • Participation [ Time Frame: 2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up ]
  • Emotional involvement [ Time Frame: 2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Graded Exposure (GEXP) in Vivo Versus Physiotherapy in Complex Regional Pain Syndrome Type I (CRPS-I)
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Complex Regional Pain Syndrome Type I
Intervention  ICMJE
  • Behavioral: Graded exposure in vivo
    Graded exposure in vivo according to the protocol of de Jong et al. (2005)
  • Behavioral: Physiotherapy
    Physiotherapy according to the protocol of Oerlemans, Oostendorp, de Boo and Goris (1999)
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Behavioral: Graded exposure in vivo
  • Experimental: 2
    Intervention: Behavioral: Physiotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 18, 2014)
46
Original Estimated Enrollment  ICMJE
 (submitted: February 28, 2008)
110
Actual Study Completion Date  ICMJE September 2014
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00625976
Other Study ID Numbers  ICMJE MEC 08-3-004
NL20067.068.08
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Maastricht University Medical Center
Study Sponsor  ICMJE Maastricht University Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marielle Goossens, Dr. Maastricht University
PRS Account Maastricht University Medical Center
Verification Date September 2014

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