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

NCT00625976 | Completed

• 2 other identifiers: MEC 08-3-004NL20067.068.08
• Study Type: interventional
• Target: 46
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Complex Regional Pain Syndrome Type I

Keywords

Complex regional pain syndrome type I; Graded exposure in vivo; Physiotherapy; Pain-related fear

Outcome Measures

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

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

Secondary Outcomes (9)

• Physical activity in daily life

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

• Body function and structure

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

• Fear of movement

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

• Fear of pain

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

• Catastrophizing Scale

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

Study Arms (2)

1

EXPERIMENTAL

Behavioral: Graded exposure in vivo

2

EXPERIMENTAL

Behavioral: Physiotherapy

Interventions

Graded exposure in vivo BEHAVIORAL

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

1

Physiotherapy BEHAVIORAL

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

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maastricht University Medical Center: lead

MeSH Terms

Conditions

Complex Regional Pain Syndromes

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Autonomic Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Marielle Goossens, Dr.

  Maastricht University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2008
• First Posted: February 29, 2008
• Study Start: May 1, 2008
• Primary Completion: December 1, 2012
• Study Completion: September 1, 2014
• Last Updated: September 19, 2014

Record last verified: 2014-09