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Completed

NCT Number: NCT00625976

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis CRPS-I according to IASP criteria.
  • Pain related (PHODA-LE-score ≥ 35 and PHODA-UE-score ≥ 32)
  • Age between 18 and 65.
  • Rehabilitation treatment has been indicated.

Exclusion criteria

  • Pregnancy.
  • Insufficient fluency in Dutch.
  • Generalized pain syndrome.
  • Dystonia.
  • Sympathectomy of the affected extremity.
  • Psychopathology
  • Involvement in a claim regarding the disease.
  • Substance abuse.
  • Symptoms on both upper or both lower extremities.

Treatment and study plan

Graded exposure in vivo

Behavioral

Graded exposure in vivo according to the protocol of de Jong et al. (2005)

Physiotherapy

Behavioral

Physiotherapy according to the protocol of Oerlemans, Oostendorp, de Boo and Goris (1999)

Primary outcomes

  1. 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

Secondary outcomes

  1. Physical activity in daily life

    Time frame: 2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up

  2. Body function and structure

    Time frame: 2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up

  3. Fear of movement

    Time frame: 2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up

  4. Fear of pain

    Time frame: 2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up

  5. Catastrophizing Scale

    Time frame: 2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up

  6. Coping with pain

    Time frame: 2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up

  7. Emotional distress

    Time frame: 2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up

  8. Participation

    Time frame: 2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up

  9. Emotional involvement

    Time frame: 2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2012
Study completion
2014
First posted
Feb 29, 2008
Registry last updated
Sep 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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