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Open Access Highly Accessed Study protocol

Study design and methods of the BoTULS trial: a randomised controlled trial to evaluate the clinical effect and cost effectiveness of treating upper limb spasticity due to stroke with botulinum toxin type A

Helen Rodgers12*, Lisa Shaw1, Christopher Price3, Frederike van Wijck4, Michael Barnes5, Laura Graham5, Gary Ford1, Phil Shackley6, Nick Steen2 and BoTULS investigators

Author Affiliations

1 Institute for Ageing and Health (Stroke Research Group), Newcastle University, Newcastle upon Tyne NE4 5PL, UK

2 Institute of Health and Society, Newcastle University, Newcastle Upon Tyne NE2 4AA, UK

3 Northumbria Healthcare NHS Trust, Wansbeck General Hospital, Ashington, Northumberland NE63 9JJ, UK

4 School of Health Sciences, Queen Margaret University, Queen Margaret University Drive, Edinburgh EH21 6UU, UK

5 International Centre for Neurorehabilitation, Walkergate Park, Benfield Road, Newcastle upon Tyne NE6 4QD, UK

6 School of Medicine and Biomedical Sciences, University of Sheffield, Samuel Fox House, Northern General Hospital, Sheffield S5 7AU, UK

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Trials 2008, 9:59  doi:10.1186/1745-6215-9-59

Published: 23 October 2008

Abstract

Background

Following a stroke, 55–75% of patients experience upper limb problems in the longer term. Upper limb spasticity may cause pain, deformity and reduced function, affecting mood and independence. Botulinum toxin is used increasingly to treat focal spasticity, but its impact on upper limb function after stroke is unclear.

The aim of this study is to evaluate the clinical and cost effectiveness of botulinum toxin type A plus an upper limb therapy programme in the treatment of post stroke upper limb spasticity.

Methods

Trial design : A multi-centre open label parallel group randomised controlled trial and economic evaluation.

Participants : Adults with upper limb spasticity at the shoulder, elbow, wrist or hand and reduced upper limb function due to stroke more than 1 month previously.

Interventions : Botulinum toxin type A plus upper limb therapy (intervention group) or upper limb therapy alone (control group).

Outcomes : Outcome assessments are undertaken at 1, 3 and 12 months. The primary outcome is upper limb function one month after study entry measured by the Action Research Arm Test (ARAT). Secondary outcomes include: spasticity (Modified Ashworth Scale); grip strength; dexterity (Nine Hole Peg Test); disability (Barthel Activities of Daily Living Index); quality of life (Stroke Impact Scale, Euroqol EQ-5D) and attainment of patient-selected goals (Canadian Occupational Performance Measure). Health and social services resource use, adverse events, use of other antispasticity treatments and patient views on the treatment will be compared. Participants are clinically reassessed at 3, 6 and 9 months to determine the need for repeat botulinum toxin type A and/or therapy.

Randomisation : A web based central independent randomisation service.

Blinding : Outcome assessments are undertaken by an assessor who is blinded to the randomisation group.

Sample size : 332 participants provide 80% power to detect a 15% difference in treatment successes between intervention and control groups. Treatment success is defined as improvement of 3 points for those with a baseline ARAT of 0–3 and 6 points for those with ARAT of 4–56.

Trial registration

ISRCTN78533119

EudraCT 2004-002427-40

CTA 17136/0230/001

Funding

National Institute for Health Research, Health Technology Assessment Programme.

Ipsen Ltd provide botulinum toxin type A (Dysport®).