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Pain Exposure Physical Therapy (PEPT) Versus CBO in Patients With Complex Regional Pain Syndrome Type I (CRPS-1)

NCT00817128 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2013-07-24

No results posted yet for this study

Summary

The current Dutch CBO guideline treatment of Complex Regional Pain Syndrome Type I (CRPS-1) is very disappointing with chronification, disability and subsequent high medical costs and personal suffering. A possible better treatment is intensive function-oriented physical therapy or Pain Exposure in Physical Therapy (PEPT). However, there are no adequate studies performed that demonstrate the efficacy of PEPT and therefore PEPT is lacking in the Dutch CBO CRPS-1 guidelines. Despite a lacking scientific argumentation, the PEPT approach or Macedonian therapy, is now being adopted on a large scale among physical therapists in The Netherlands. There are two level C retrospective cohort studies demonstrating a promising and clinical relevant beneficial effect on pain and function after PEPT. In response to the growing demand for scientific argumentation among doctors and physical therapists with respect to the efficacy of PEPT, we conducted a pilot study at the UMC St Radboud Nijmegen. The results of this pilot study were very promising and therefore, we decided to design a large RCT to investigate the treatment effects and costs in CRPS patients treated with PEPT compared to CRPS patients treated with usual therapy according to the Dutch CBO guidelines.

Conditions

  • Complex Regional Pain Syndrome, Type I

Interventions

PROCEDURE

PEPT

Pain Exposure Physical Therapy

PROCEDURE

CBO standard

Standard therapy as defined in CBO guideline 2006

Sponsors & Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

    collaborator OTHER

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • Jan Paul Frölke, MD; PhD · Radboud University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2012-03-31
Completion
2012-07-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00817128 on ClinicalTrials.gov