Title: Is it clinically effective to treat arm flexor spasticity, with Botulinum toxin – type A (BoNTA) and physiotherapy, as soon as signs of abnormal muscle activity is observed? (A phase II study)
Funder: Department of Health (England)

Abstract: Background Disability after a stroke is a significant problem. The ensuing loss of independence places a substantial burden on individuals, their families and the State. Spasticity commonly develops after a stroke and can interfere with recovery of function and lead to secondary complications. Existing treatments for spasticity can be effective in treating the primary symptoms (i.e. abnormal muscle activity) but the impact on secondary complications is limited. It is envisaged that by identifying and treating spasticity earlier, using newly developed methods of detection, could prevent the development of secondary complications. If successful this will improve the patient outcomes and reduce long term management costs. The new care pathway could immediately be implemented into NHS practice. Aims Upper limb spasticity affecting the wrist and elbow is a significant problem in stroke. In current practice, treatment to manage spasticity is normally initiated only after clinical signs of joint stiffness and/or adaptive shortening in muscles are seen. Treating spasticity using a combination of BoNTA and standardised therapy, as soon as signs of abnormal muscle activity are observed, may be more effective in preventing secondary complications of stiffness, contractures and pain. Such treatment may also facilitate the recovery of function and/or reduce the burden of care. Aims: To investigate the cost effectiveness of early detection and treatment of upper limb spasticity with BoNTA and a standardised package of therapy against current practice (i.e. rehabilitation therapy). Plan of Investigation Newly diagnosed stroke patients (n = 150) who have no useful arm function and spasticity in the arm flexors will be eligible for study inclusion. A randomised double blind placebo controlled study design will be used. Patients in the control group will be given placebo injections to the arm flexors and those in the treatment group will receive injections of BoNTA (average dose/patient 200 Botox Units). Patients in both groups will receive a standardised package of physiotherapy (which will reflect current practice in the lead NHS Trust). Measures of quality of life (EQ5D), arm function, spasticity, and secondary complications will be taken. Cost effectiveness and cost utility analysis will be done in addition to effect size calculations. Primary end point will be six months post stroke. Potential Impact In the last decade significant advances have been made in our understanding and treatment of spasticity. Emerging research evidence suggests that existing NHS practice can be further optimised. If found effective this new pathway can be immediately implemented within the NHS and, in addition to providing significant benefit to the patient, has the potential for significant cost saving. The assessment framework used to measure efficacy of treatment can form the basis of an audit tool that can then be used to monitor service provision associated with spasticity treatment in general. The findings from this study also have the potential to inform the management of lower limb spasticity and spasticity in other neurological conditions.


Research activity codes: 6.1 PHARMACEUTICALS
Health categories: STROKE