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Open Access Highly Accessed Study protocol

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

Karlijn J Barnhoorn, Rob A B Oostendorp, Robert T M van Dongen, Frank P Klomp, Han Samwel, Gert Jan van der Wilt, Eddy Adang, Hans Groenewoud, Henk van de Meent and Jan Paul M Frölke*

Author Affiliations

Department of surgery 690, Radboud University Nijmegen Medical Centre, Nijmegen, Postbox 9101, 6500, HB, The Netherlands

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BMC Musculoskeletal Disorders 2012, 13:58  doi:10.1186/1471-2474-13-58

Published: 19 April 2012

Abstract

Background

Pain Exposure Physical Therapy is a new treatment option for patients with Complex Regional Pain Syndrome type 1. It has been evaluated in retrospective as well as in prospective studies and proven to be safe and possibly effective. This indicates that Pain Exposure Physical Therapy is now ready for clinical evaluation. The results of an earlier performed pilot study with an n = 1 design, in which 20 patients with Complex Regional Pain Syndrome type 1 were treated with Pain Exposure Physical Therapy, were used for the design and power calculation of the present study.

After completion and evaluation of this phase III study, a multi-centre implementation study will be conducted.

The aim of this study is to determine whether Pain Exposure Physical Therapy can improve functional outcomes in patients with Complex Regional Pain Syndrome type 1.

Methods/design

This study is designed as a single-blinded, randomized clinical trial. 62 patients will be randomized with a follow-up of 9 months to demonstrate the expected treatment effect. Complex Regional Pain Syndrome type 1 is diagnosed in accordance with the Bruehl/International Association for the Study of Pain criteria. Conventional therapy in accordance with the Dutch guideline will be compared with Pain Exposure Physical Therapy. Primary outcome measure is the Impairment level SumScore, restricted version.

Discussion

This is the first randomized controlled study with single blinding that has ever been planned in patients with Complex Regional Pain Syndrome type 1 and does not focus on a single aspect of the pain syndrome but compares treatment strategies based on completely different pathophysiological and cognitive theories.

Trial registration

Clinical trials NCT00817128; National Trial Register NTR2090