BOTULINUM TOXIN (DYSPORT) TREATMENT OF UPPER LEG ADDUCTOR SPASTICITY IN MULTIPLE SCLEROSIS: A PROSPECTIVE, RANDOMISED, DOUBLE BLIND, PLACEBO CONTROLLED, DOSE RANGING STUDY
Michael P Barnes-1, Hyman N, Bhakta B, Cozens A, Bakheit M et al
(1- Hunters Moor Regional Rehabilitation Centre, Newcastle upon Tyne, UK)
A number of reports now confirm a role for botulinum toxin in the treatment of upper leg adductor spasticity. Reduction in adductor spasticity can alleviate pain, improve hygiene and minimise the risk of unnecessary complications including pressure sores. The aim of this placebo controlled dose ranging study was to define a safe and effective dose of Dysport for treating this group of individuals. A total of eight European centres recruited 74 patients with disabling spasticity affecting the adductor group of muscles in association with different or probable multiple sclerosis and a Kurtzke EDS score >7. Patients received either Dysport 500, 1000 or 1500 units or placebo injected into the three adductor muscles of both legs. Patients were followed up at 2, 4, 8 and 12 weeks post treatment. Efficacy was assessed in terms of joint range, spasm frequency, muscle tone, upper leg pain, hygiene, duration of effect and overall clinical rating. Safety was assessed by the incidence of adverse events. The study is now complete and the results are being analysed and will be presented at the Congress.
VALIDATION OF THE MULTIPLE SCLEROSIS RAYS - A SCALE FOR QUANTIFICATION OF QUALITY OF LIFE
Z. Rotstein, Y. Barak, S. Noy, A. Achiron.
Multiple Sclerosis Center, Sheba Medical Center, Tel Hashomer, Israel
Purpose: Multiple sclerosis (MS) is a chronic disorder, currently incurable in which rehabilitation is the focus for most patients. Assessing the effects of various rehabilitation approaches needs a simply administered quantitative tool that will be sensitive to change over time. The RAYS was developed as a self-report 3 dimensional (physical, psychological, social) rating scale to score quality of life in patients suffering from MS.
Methods: Validation was achieved through administration of the RAYS to 50 randomly selected MS patients and to 50 age, sex, education and family status matched healthy controls.
Results: Physical, psychological and social dimensions among MS patients reached a Cronbach coefficient alpha greater than 0.80. Mean values for all dimensions were statistically higher in patients compared with controls (p<0.002).
Conclusions: The RAYS demonstrated high internal consistency and significant discriminative values and is thus suitable and specific for the assessment of quality of life in MS patients.