Session IX - Upper Extremity

Sat., 10/12/13 Upper Extremity, PAPER #104, 3:18 pm OTA 2013

Pain Exposure Physical Therapy Versus Conventional Therapy in Patients With Complex Regional Pain Syndrome Type 1: A Randomized Controlled Trial

Karlijn J. Barnhoorn, MD; Henk van de Meent, MD, PhD; Robert T.M. van Dongen, MD, PhD; Frank P. Klomp; Hans Groenewoud, MSc; Ria M.W.G. Nijhuis-van der Sanden, PhD; Jan Paul M. Frölke, MD, PhD;1
Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands

Background/Purpose: More than half the patients with complex regional pain syndrome type 1 (CRPS-1) do not respond well to the current conventional evidence-based treatments and may progress to chronic disease with associated disabilities and restrictions in daily life. Nonrandomized studies have shown that a more comprehensive CRPS-1 treatment, Pain Exposure Physical Therapy (PEPT), is safe and possibly effective. The aim of this study is to determine whether PEPT is more effective than current conventional treatment regarding CRPS-related impairments, activities, and quality of life.

Methods: In a single-blinded randomized controlled trial, adult patients with CRPS-1 according to the “Budapest” criteria were recruited and randomized to receive either PEPT or conventional treatment. Primary outcome was the CRPS-1 Impairment level Sum Score (ISS). Secondary outcome measures were pain intensity, muscle strength, active joint range of motion, pain disability index, activity monitor, Tampa Scale for Kinesiophobia, and quality of life. Baseline measurements were performed before treatment and follow-up measurements were done at 3, 6, and 9 months after inclusion.

Results: Between January 2009 and June 2011, 58 patients were randomly assigned to either PEPT (n = 29) or conventional (CONV) (n = 29) treatment. The Impairment level Sum Score improved significantly more in the PEPT group compared to the CONV group as primary end point. The estimated group difference for ISS-RV for patients that did not switch after randomization was 3.22 (95% confidence interval [CI] –0.29, 6.72; P = 0.076). The estimated group difference for patients who switched after randomization was 3.79 (95% CI 0.83, 6.75; P = 0.013). The secondary end points visual analog scale (VAS) pain, pain disability index, and active joint range of motion improved significantly more in patients treated with PEPT compared to CONV. The estimated group difference for VAS pain, pain disability index, and active joint range of motion was, respectively, 18.39 (95% CI 4.28, 32.48; P =0.012), 9.59 (95% CI 1.87, 17.31; P = 0.017), and 8.22 (95% CI 2.38, 14.06; P = 0.007). The secondary end points muscle strength, activity monitor, and quality of life improved more in the PEPT group compared to CONV treatment but did not reach the level of significance. The improvement in kinesiophobia was equal in both groups. None of the patients reported serious side-effects or disease deterioration.

Conclusion: Pain Exposure Physical Therapy is a safe, nonpharmacological, and effective treatment of CRPS-1 and is superior to the current evidence-based conventional treatment.

Funding: Funds for this study were received from the Netherlands Organisation for Health Research and Development (ZonMW).

Alphabetical Disclosure Listing

• The FDA has not cleared this drug and/or medical device for the use described in this presentation   (i.e., the drug or medical device is being discussed for an “off label” use).  ◆FDA information not available at time of printing. Δ OTA Grant.