NCT00817128

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2009

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

January 5, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 6, 2009

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

July 24, 2013

Status Verified

July 1, 2013

Enrollment Period

3.2 years

First QC Date

January 5, 2009

Last Update Submit

July 23, 2013

Conditions

Complex Regional Pain Syndrome, Type I

Keywords

Complex Regional Pain Syndrome Type ISympathetic Reflex DystrophyPain Exposure Physical TherapyPharmacological treatmentFunctional recovery

Outcome Measures

Primary Outcomes (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

    t=0; t= 3 months; t= 6 months; t= 9 months

Secondary Outcomes (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

    t=0; t=3 months; t= 6 months; t= 9 months

Study Arms (2)

1

EXPERIMENTAL

PEPT after randomization

Procedure: PEPT

2

EXPERIMENTAL

CBO after randomization

Procedure: CBO standard

Interventions

PEPTPROCEDURE

Pain Exposure Physical Therapy

1
CBO standardPROCEDURE

Standard therapy as defined in CBO guideline 2006

2

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud University Medical Center

Nijmegen, 6525 GA, Netherlands

Location

Related Publications (8)

  • Oerlemans HM, Oostendorp RA, de Boo T, van der Laan L, Severens JL, Goris JA. Adjuvant physical therapy versus occupational therapy in patients with reflex sympathetic dystrophy/complex regional pain syndrome type I. Arch Phys Med Rehabil. 2000 Jan;81(1):49-56.

    PMID: 10638876BACKGROUND

  • Sherry DD, Wallace CA, Kelley C, Kidder M, Sapp L. Short- and long-term outcomes of children with complex regional pain syndrome type I treated with exercise therapy. Clin J Pain. 1999 Sep;15(3):218-23. doi: 10.1097/00002508-199909000-00009.

    PMID: 10524475BACKGROUND

  • Perez RS, Oerlemans HM, Zuurmond WW, De Lange JJ. Impairment level SumScore for lower extremity Complex Regional Pain Syndrome type I. Disabil Rehabil. 2003 Sep 2;25(17):984-91. doi: 10.1080/0963828031000122302.

    PMID: 12851087BACKGROUND

  • Vaneker M, Wilder-Smith OH, Schrombges P, Oerlemans HM. Impairments as measured by ISS do not greatly change between one and eight years after CRPS 1 diagnosis. Eur J Pain. 2006 Oct;10(7):639-44. doi: 10.1016/j.ejpain.2005.10.003. Epub 2005 Nov 21.

    PMID: 16300975BACKGROUND

  • Frolke JP, Bruggeman AW, Klomp FP, Smeets JL. Brugada syndrome during physical therapy: a case report. Cases J. 2008 Aug 18;1(1):107. doi: 10.1186/1757-1626-1-107.

    PMID: 18710557BACKGROUND

  • Barnhoorn KJ, van de Meent H, van Dongen RT, Klomp FP, Groenewoud H, Samwel H, Nijhuis-van der Sanden MW, Frolke JP, Staal JB. Pain exposure physical therapy (PEPT) compared to conventional treatment in complex regional pain syndrome type 1: a randomised controlled trial. BMJ Open. 2015 Dec 1;5(12):e008283. doi: 10.1136/bmjopen-2015-008283.

    PMID: 26628523DERIVED

  • Barnhoorn KJ, Staal JB, van Dongen RT, Frolke JP, Klomp FP, van de Meent H, Samwel H, Nijhuis-van der Sanden MW. Are pain-related fears mediators for reducing disability and pain in patients with complex regional pain syndrome type 1? An explorative analysis on pain exposure physical therapy. PLoS One. 2015 Apr 28;10(4):e0123008. doi: 10.1371/journal.pone.0123008. eCollection 2014.

    PMID: 25919011DERIVED

  • Barnhoorn KJ, Oostendorp RA, van Dongen RT, Klomp FP, Samwel H, van der Wilt GJ, Adang E, Groenewoud H, van de Meent H, Frolke JP. The effectiveness and cost evaluation of pain exposure physical therapy and conventional therapy in patients with complex regional pain syndrome type 1. Rationale and design of a randomized controlled trial. BMC Musculoskelet Disord. 2012 Apr 19;13:58. doi: 10.1186/1471-2474-13-58.

    PMID: 22515496DERIVED

MeSH Terms

Conditions

Reflex Sympathetic DystrophyComplex Regional Pain Syndromes

Interventions

1,10-phenanthroline-platinum(II)-ethylenediamine

Condition Hierarchy (Ancestors)

Autonomic Nervous System DiseasesNervous System DiseasesPeripheral Nervous System DiseasesNeuromuscular Diseases

Study Officials

  • Jan Paul Frölke, MD; PhD

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD, Department of Surgery

Study Record Dates

First Submitted

January 5, 2009

First Posted

January 6, 2009

Study Start

January 1, 2009

Primary Completion

March 1, 2012

Study Completion

July 1, 2012

Last Updated

July 24, 2013

Record last verified: 2013-07

Locations

NL(1)