Graded motor imagery for women at risk for developing type I CRPS following closed treatment of distal radius fractures: a randomized comparative effectiveness trial protocol

Abstract

Background: Distal radius fractures (DRF) account for nearly one-fifth of all fractures in older adults, and women experience them 5× as often as men. Most DRF occur with low impact injuries to the wrist with an outstretched hand, and are often managed via closed treatment and cast immobilization. Women sustaining a DRF are at risk for upper limb immobility, sensorimotor changes, edema and type I complex regional pain syndrome (CRPS). Since CRPS onset is likely influenced by alterations in the brain's somatosensory region, a rehabilitation intervention, Graded Motor Imagery (GMI), aims to restore cortical representation, including sensory and motor function, of the affected limb. To date, there are no studies on the use of GMI in reducing risk of or preventing the onset of type I CRPS in women with DRF treated with cast immobilization. Due to a higher likelihood of women with this injury developing type I CRPS, it is important to early intervention is needed.

Methods/design: This article describes a six-week randomized comparative effectiveness trial, where the outcomes of a modified GMI program (mGMI) + standard of care (SOC) group (n = 33) are compared to a SOC only control group (n = 33). Immediately following cast immobilization, both groups participate in four 1-h clinic-based sessions, and a home program for 10 min three times daily until cast removal. Blinded assessments occur within 1 week of cast immobilization (baseline), at three weeks post cast immbolization, cast removal, and at three months post cast removal. The primary outcomes are patient reported wrist/hand function and symptomology on the Patient Rated Wristand Hand Evaluation, McGill Pain Questionnaire, and Budapest CRPS Criteria. The secondary outcomes are grip strength, active range of motion as per goniometry, circumferential edema measurements, and joint position sense.

Discussion: This study will investigate the early effects of mGMI + SOC hand therapy compared to SOC alone. We intend to investigate whether an intervention, specifically mGMI, used to treat preexisiting pain and motor dysfunction might also be used to mitigate these problems prior to their onset. If positive effects are observed, mGMI + SOC may be considered for incorporation into early rehabilitation program.

Trial registration: This trial is registered at ClinicalTrials.gov with identifier NCT02957240 (Approval date: April 20, 2017).

Keywords: Cast; Clinical trial; Complex regional pain syndrome; Distal radius fracture; Graded motor imagery; Immobilization; Mirror therapy; Movement representation techniques; Non-operative; Women.

Conflict of interest statement

Authors’ information

For more information about Dr. McGee, Assistant professor in Occupational Therapy and Rehabilitation Science, and his research, please follow him at www.researchgate.net/profile/Corey_McGee

Ethics approval and consent to participate

This study is approved by the University of Minnesota’s Institutional Review Board (IRB # 1701 M03721) and all authors are approved investigators. All who are enrolled in the study will be provide written consent in a fashion consistent with those approved by the University of Minnesota’s institutional review board and the Declaration of Helsinki. This study is registered at ClinicalTrials.gov (NCT02957240).

Competing interests

The authors declare that they have no competing interests.

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Figures

Fig. 1

Flow of participants

Fig. 2

Examples of photos for mGMI phases 1 and 2

Fig. 3

Phase 3: Mirror Therapy