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

This study has been completed.
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
Jan Paul Frolke, Radboud University
ClinicalTrials.gov Identifier:
NCT00817128
First received: January 5, 2009
Last updated: July 23, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Complex Regional Pain Syndrome, Type I
Procedure: PEPT
Procedure: CBO standard
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pain Exposure Physical Therapy Or Conservative Therapy for Patients With Complex Regional Pain Syndrome Type I

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • Primary outcome measure is the Impairment level SumScore (ISS): pain, active range of motion and temperature, measured with VAS, McGill Pain Questionnaire, goniometry of mobility of joints and skin thermometer [ Time Frame: t=0; t= 3 months; t= 6 months; t= 9 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • DASH; FABQ; SF36; mycrofet dynamometer; RSQ; 10 meter walking test and the timed up-and-go-test; Adherence behavior; Seven Days PAR; IPAQ; PCS; PDI; PAM; Economic evaluation with diary; EuroQol 5D; adverse reactions SAE forms [ Time Frame: t=0; t=3 months; t= 6 months; t= 9 months ] [ Designated as safety issue: Yes ]

Enrollment: 62
Study Start Date: January 2009
Study Completion Date: July 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
PEPT after randomization
Procedure: PEPT
Pain Exposure Physical Therapy
Experimental: 2
CBO after randomization
Procedure: CBO standard
Standard therapy as defined in CBO guideline 2006

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients between 18 and 80 years of age with Complex Regional pain Syndrome (CRPS-1) of either upper or lower extremity according to Bruehl's/IASP criteria between 3 and 24 months after initial injury will be selected for the study.

Exclusion Criteria:

Patients who do not comply with the inclusion criteria especially those who have other causes that may explain a pain syndrome will be excluded (IASP criterium)

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00817128

Locations
Netherlands
Radboud University Medical Center
Nijmegen, Netherlands, 6525 GA
Sponsors and Collaborators
Radboud University
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
Principal Investigator: Jan Paul Frölke, MD; PhD Radboud University
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jan Paul Frolke, MD PhD, Department of Surgery, Radboud University
ClinicalTrials.gov Identifier: NCT00817128     History of Changes
Other Study ID Numbers: 170991004, ZonMw 1709901004
Study First Received: January 5, 2009
Last Updated: July 23, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:
Complex Regional Pain Syndrome Type I
Sympathetic Reflex Dystrophy
Pain Exposure Physical Therapy
Pharmacological treatment
Functional recovery

Additional relevant MeSH terms:
Syndrome
Complex Regional Pain Syndromes
Somatoform Disorders
Reflex Sympathetic Dystrophy
Disease
Pathologic Processes
Mental Disorders
Autonomic Nervous System Diseases
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases

ClinicalTrials.gov processed this record on September 18, 2014