Rehabilitation plus OnabotulinumtoxinA Improves Motor Function over OnabotulinumtoxinA Alone in Post-Stroke Upper Limb Spasticity: A Single-Blind, Randomized Trial

Wow, researching something that is standard knowledge for at least a decade. Botox alone does nothing for stroke recovery. Where are the stroke leaders than should have prevented this waste of time and money? With a publicly available database of stroke protocols this waste could have been prevented.
http://www.mdpi.com/2072-6651/9/7/216/htm

Deidre Devier ^1,*, JoAnn Harnar ^2,3, Leandro Lopez ³, Allison Brashear ⁴ and Glenn Graham ⁵

¹

Department of Neurology, 1542 Tulane Ave, Room 111B, New Orleans, LA 70112, USA

²

Department of Neurology, MSC10 5620, Health Sciences Center. 1 University of New Mexico, Albuquerque, NM 87131-0001, USA

³

New Mexico VA Healthcare System, 1501 San Pedro SE, Albuquerque, New Mexico, NM 87108, USA

⁴

Department of Neurology, Wake Forest University Baptist Medical Center, Medical Center Blvd, Winston Salem, NC 27157, USA

⁵

VA Medical Center, 4150 Clement St, San Francisco, CA 94121, USA

*

Correspondence: Tel.: +504-568-2146; Fax: +504-324-0655

Received: 24 February 2017 / Accepted: 29 June 2017 / Published: 11 July 2017

Abstract

:

Background: OnabotulinumtoxinA (BoNT-A) can temporarily decrease spasticity following stroke, but whether there is an associated improvement in upper limb function is less clear. This study measured the benefit of adding weekly rehabilitation to a background of BoNT-A treatments for chronic upper limb spasticity following stroke. Methods: This was a multi-center clinical trial. Thirty-one patients with post-stroke upper limb spasticity were treated with BoNT-A. They were then randomly assigned to 24 weeks of weekly upper limb rehabilitation or no rehabilitation. They were injected up to two times, and followed for 24 weeks. The primary outcome was change in the Fugl–Meyer upper extremity score, which measures motor function, sensation, range of motion, coordination, and speed. Results: The ‘rehab’ group significantly improved on the Fugl–Meyer upper extremity score (Visit 1 = 60, Visit 5 = 67) while the ‘no rehab’ group did not improve (Visit 1 = 59, Visit 5 = 59; p = 0.006). This improvement was largely driven by the upper extremity “movement” subscale, which showed that the ‘rehab’ group was improving (Visit 1 = 33, Visit 5 = 37) while the ‘no rehab’ group remained virtually unchanged (Visit 1 = 34, Visit 5 = 33; p = 0.034). Conclusions: Following injection of BoNT-A, adding a program of rehabilitation improved motor recovery compared to an injected group with no rehabilitation.

Keywords:

stroke; rehabilitation; onabotulinumtoxinA; occupational therapy; muscle spasticity; physical therapy

1. Introduction

While several blinded and open-label studies have demonstrated the ability of botulinum toxin to temporarily decrease spasticity following stroke, as measured by standard assessments such as the Modified Ashworth Scale [1,2,3,4,5,6,7,8], the ability of botulinum toxin to improve upper limb function following stroke is less clear, with some studies [1,3,4,5,6,7,8], though not all [2,7], reporting functional improvement. Two recent meta-analyses of randomized controlled trials demonstrated that botulinum toxin treatment resulted in a moderate improvement in upper limb function [9,10]. Despite large clinical trials [2,3,11] and FDA approval, the exact timing, use of adjunct rehabilitation, and continuation of lifelong botulinum toxin treatment remains unclear [12,13].

A recent Cochrane Review included three randomized clinical trials for post-stroke spasticity involving 91 participants [14]. It aimed to determine the efficacy of multidisciplinary rehabilitation programs following treatment with botulinum toxin, and found some evidence supporting modified constraint-induced movement therapy and dynamic elbow splinting. There have been varied study designs exploring rehabilitation in persons after the injection of botulinum toxin or a placebo [13,15], rehabilitation in persons after the injection of botulinum toxin or no injection [16], or rehabilitation after the injection of botulinum toxin with no control condition [17]. As the use of botulinum toxin expands and is beneficial in reducing spasticity and costs [18], the benefit of adding upper limb rehabilitation continues to be questioned. We designed this multi-center, randomized, single-blind clinical trial to assess improvement in patient sensory and motor outcome following the injection of onabotulinumtoxinA (BoNT-A), comparing the effects of rehabilitation versus no rehabilitation, using the upper extremity portion of the Fugl–Meyer Assessment of Sensorimotor Recovery After Stroke [19] as the primary outcome measure. While patients could not be blinded to their randomization to receive additional rehabilitation versus no rehabilitation, the assessments of all of the outcome measures were performed by evaluators blinded to rehabilitation assignment in this single-blind design.

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