Pain exposure physical therapy (PEPT) compared to conventional treatment in complex regional pain syndrome type 1: a randomised controlled trial

Karlijn J Barnhoorn, Henk van de Meent, Robert T M van Dongen, Frank P Klomp, Hans Groenewoud, Han Samwel, Maria W G Nijhuis-van der Sanden, Jan Paul M Frölke, J Bart Staal, Karlijn J Barnhoorn, Henk van de Meent, Robert T M van Dongen, Frank P Klomp, Hans Groenewoud, Han Samwel, Maria W G Nijhuis-van der Sanden, Jan Paul M Frölke, J Bart Staal

Abstract

Objective: To compare the effectiveness of pain exposure physical therapy (PEPT) with conventional treatment in patients with complex regional pain syndrome type 1 (CRPS-1) in a randomised controlled trial with a blinded assessor.

Setting: The study was conducted at a level 1 trauma centre in the Netherlands.

Participants: 56 adult patients with CRPS-1 participated. Three patients were lost to follow-up.

Interventions: Patients received either PEPT in a maximum of five treatment sessions, or conventional treatment following the Dutch multidisciplinary guideline.

Measurements: Outcomes were assessed at baseline and at 3, 6 and 9 months after randomisation. The primary outcome measure was the Impairment level Sum Score--Restricted Version (ISS-RV), consisting of visual analogue scale for pain (VAS-pain), McGill Pain Questionnaire, active range of motion (AROM) and skin temperature. Secondary outcome measures included Pain Disability Index (PDI); muscle strength; Short Form 36 (SF-36); disability of arm, shoulder and hand; Lower Limb Tasks Questionnaire (LLTQ); 10 m walk test; timed up-and-go test (TUG) and EuroQol-5D.

Results: The intention-to-treat analysis showed a clinically relevant decrease in ISS-RV (6.7 points for PEPT and 6.2 points for conventional treatment), but the between-group difference was not significant (0.96, 95% CI -1.56 to 3.48). Participants allocated to PEPT experienced a greater improvement in AROM (between-group difference 0.51, 95% CI 0.07 to 0.94; p=0.02). The per protocol analysis showed larger and significant between-group effects on ISS-RV, VAS-pain, AROM, PDI, SF-36, LLTQ and TUG.

Conclusions: We cannot conclude that PEPT is superior to conventional treatment for patients with CRPS-1. Further high-quality research on the effects of PEPT is warranted given the potential effects as indicated by the per protocol analysis.

Trial registration numbers: NCT00817128 and NTR 2090.

Keywords: PAIN MANAGEMENT; REHABILITATION MEDICINE.

Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Figures

Figure 1
Figure 1
Trial profile (CONV, conventional treatment; ITT, intention-to-treat; PP, per protocol; PEPT, pain exposure physical therapy).
Figure 2
Figure 2
Outcomes of the Impairment level Sum Score—Restricted Version (ISS-RV) and its subscales, and the Pain Disability Index. Data are based on raw data; mean (95% CI). Light lines, pain exposure physical therapy group. Dark lines, conventional treatment group. (A) Primary outcome ISS-RV and its subscales, intention-to-treat. (B) Pain Disability Index, intention-to-treat. (C) Primary outcome ISS-RV and its subscales, per protocol. (D) Pain Disability Index, per protocol (ISS-RV, Impairment level Sum Score—Restricted Version; VAS, visual analogue scale).

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