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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Randomize

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

Detailed Summary:
Sponsor: Maastricht University Medical Center

Current Primary Outcome: 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: Same as current

Current Secondary Outcome:

  • 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: Same as current

Information By: Maastricht University Medical Center

Dates:
Date Received: February 21, 2008
Date Started: May 2008
Date Completion:
Last Updated: September 18, 2014
Last Verified: September 2014