Pain Exposure Physical Therapy (PEPT) Versus CBO in Patients With Complex Regional Pain Syndrome Type I (CRPS-1) (PEPTOC)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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 ]
- 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: | January 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 |
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| Netherlands | |
| Radboud University Medical Center | |
| Nijmegen, Netherlands, 6525 GA | |
| Principal Investigator: | Jan Paul Frölke, MD; PhD | Radboud University |
More Information
Additional 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: | September 25, 2012 |
| 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:
|
Reflex Sympathetic Dystrophy Somatoform Disorders Complex Regional Pain Syndromes Autonomic Nervous System Diseases |
Nervous System Diseases Peripheral Nervous System Diseases Neuromuscular Diseases Mental Disorders |
ClinicalTrials.gov processed this record on June 18, 2013