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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00817128
Recruitment Status : Completed
First Posted : January 6, 2009
Last Update Posted : July 24, 2013
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
Jan Paul Frolke, Radboud University

Brief 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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pain Exposure Physical Therapy Or Conservative Therapy for Patients With Complex Regional Pain Syndrome Type I
Study Start Date : January 2009
Actual Primary Completion Date : March 2012
Actual Study Completion Date : July 2012

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00817128

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Radboud University Medical Center
Nijmegen, Netherlands, 6525 GA
Sponsors and Collaborators
Radboud University
ZonMw: The Netherlands Organisation for Health Research and Development
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Principal Investigator: Jan Paul Frölke, MD; PhD Radboud University
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Jan Paul Frolke, MD PhD, Department of Surgery, Radboud University Identifier: NCT00817128    
Other Study ID Numbers: 170991004
ZonMw 1709901004 ( Other Grant/Funding Number: ZonMw 1709901004 )
First Posted: January 6, 2009    Key Record Dates
Last Update Posted: July 24, 2013
Last Verified: July 2013
Keywords provided by Jan Paul Frolke, Radboud University:
Complex Regional Pain Syndrome Type I
Sympathetic Reflex Dystrophy
Pain Exposure Physical Therapy
Pharmacological treatment
Functional recovery
Additional relevant MeSH terms:
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Complex Regional Pain Syndromes
Reflex Sympathetic Dystrophy
Somatoform Disorders
Pathologic Processes
Mental Disorders
Autonomic Nervous System Diseases
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases