Med J Malaysia Vol 62 No 4 October 2007 319 SUMMARY Botulinum toxin is effective in reducing spasticity post stroke. As there are limited data on post stroke spasticity in Asia, we undertake this study to determine the effectiveness and safety of intramuscular injection of botulinum toxin type-A (BTX-A), in the treatment of chronic focal post-stroke hand spasticity, and the impact of BTX-A on the activities of daily living and quality of life, in comparison to placebo, in Malaysian stroke patients. This was a randomized, double- blind, placebo-controlled study to assess the efficacy and safety of BTX-A in 27 subjects with wrist and finger spasticity after a stroke. The outcome measures were assessed with the Modified Ashworth Scale (MAS) to assess spasticity of the flexor muscles, Barthel Index (BI) for activities of daily living and EQ-5D and EQ VAS for quality of life. Assessments were performed at baseline and 1 and 3 months after injection. Compared to placebo, the BTX-A group had greater improvement in the flexor tone of the wrist and fingers (p=0.001 and p<0.001, respectively), at first month follow-up visit and sustained the improvement through to three months. Although there was an improvement in the measures of global function and quality of life in the BTX-A group, there was no significant improvement in between the two groups. No serious BTX-A related adverse effects were reported. The results of this study demonstrate that intramuscular injection of botulinum toxin A is safe and effective in the treatment of chronic focal post-stroke spasticity of the hand. KEY WORDS: Post stroke spasticity, Botulinum toxin A INTRODUCTION Stroke is a leading cause of serious long term disability. Despite considerable rehabilitative efforts, the prognosis for recovery of upper limb function after a stroke remains poor. Arm involvement is common with weakness up to 69% at admission to hospital 1 . Long term recovery of arm movement is often poor in patients presenting with a completely paralysed arm. Impairment in the upper limb function contributes to reduced quality of life, increases dependence and interferes with rehabilitation and functional recovery. In patients with complete arm paralysis, spasticity can be an important contributor to disability, by causing pain or interfering with hygiene and dressing. The conventional treatment for severe upper limb spasticity includes neural depressants (baclofen, benzodiazepines, clonidine, and tizanidine), muscle relaxants (dantrolene sodium) and nerve blocks (phenol, alcohol). These oral agents are limited by their side effects such as generalized weakness and sedation 2 whereas the nerve blocks cause dysesthesia and local tissue necrosis. Injections of botulinum toxin A have revolutionized the treatment of focal spasticity. It is an established treatment for squint, blepharospasm, hemifacial spasm, torticollis, focal dystonias and limb spasticity. Although there are numerous studies evaluating botulinum toxin A in upper limb spasticity from stroke 3-8 , the data in the Asian population is still lacking. We performed this study to assess the effectiveness, safety and the impact of botulinum toxin on activities of daily living and quality of life in post stroke hand spasticity in the Malaysian patients. MATERIALS AND METHODS This was a randomized double blind placebo controlled study, conducted from June 2006 to November 2006 at Hospital Universiti Kebangsaan Malaysia (HUKM). We included subjects who were at least 21 years of age, had stroke at least a year earlier, had focal spasticity of the wrist and fingers at least three months before enrollment and the muscle tone score of more than or equals to 2 on the Modified Ashworth Scale (MAS). Exclusion criteria were a fixed muscle contracture or profound muscle atrophy in the spastic limb, prior treatment of the limb with botulinum injection or nerve blocks, treatment with agents affecting neuromuscular transmission, neuromuscular diseases, active infection at the injection sites or systemic infection, and pregnant or lactating women. Subjects were randomly assigned to receive a total dose of 80 units of botulinum toxin A (Botox®, Allergen, Irvine, CA, USA) or placebo. 2.2 mls of 0.9% saline (0.2 ml to compensate for dead space) were reconstituted in one vial of Botox containing 100 units. Twenty units (0.4 mls) of Botox or 0.4 mls saline (placebo) were injected in each muscle of wrist flexors (flexor carpi radialis, flexor carpi ulnaris) and finger flexors (flexor digitorum superficialis, flexor digitorum profundus) by a single injector. Following injection, all patients underwent regular physiotherapy sessions, each lasting one hour, twice weekly for three months. Subjects were assessed at baseline, month 1 and 3 for muscle tone and global measures of function and quality of life. The tone of the wrist and finger flexors was evaluated with the use of the five point Modified Ashworth Scale (MAS) 10 . MAS measures resistance to passive movements according to the Intramuscular Injection of Botulinum Toxin for the Treatment of Wrist and Finger Spasticity after Stroke A W Jahangir, MMed, H J Tan, MMed, M I Norlinah, MRCP, W Y Nafisah, MMed, S Ramesh, MMed, B B Hamidon, MMed, A A Raymond, FRCP Department of Medicine, Faculty of Medicine, Universiti Kebangsaan Malaysia, Jalan Yaacob Latif, 56000 Cheras, Kuala Lumpur ORIGINAL ARTICLE This article was accepted: 8 September 2007 Corresponding Author: Tan Hui Jan, Department of Medicine, Faculty of Medicine, Universiti Kebangsaan Malaysia, Jalan Yaacob Latif, 56000 Cheras, Kuala Lumpur Email: tanhuijan@hotmail.com