What is the clinical effect and cost effectiveness of treating upper limb spasticity due to stroke with botulinum toxin?

ISRCTN	ISRCTN78533119
DOI	https://doi.org/10.1186/ISRCTN78533119
Secondary identifying numbers	HTA 02/41/06

Submission date: 06/08/2004
Registration date: 06/08/2004
Last edited: 07/12/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Helen Rodgers
Scientific

School of Population & Health Sciences
University of Newcastle
The Medical School
Newcastle upon Tyne
NE2 4HH
United Kingdom

Phone	+44 (0)191 222 6779
Email	helen.rodgers@ncl.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study objectives	Objective: To compare the upper limb (UL) function of patients with spasticity due to stroke who receive botulinum toxin injection(s) to the upper arm plus a four week evidence based UL therapy programme (intervention group) with patients who receive the UL therapy programme alone (control group) at 1 month after study entry. Protocol can be found at http://www.hta.ac.uk/protocols/200200410006.pdf More details can be found at http://www.hta.ac.uk/1408 Please note that, as of 26/08/2009, the anticipated end date of this trial has been updated from 31/07/2008 to 28/02/2009.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Upper limb spasticity due to stroke
Intervention	Intervention: Botulinum toxin plus upper limb therapy programme Control: Upper limb therapy programme alone
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Botulinum toxin
Primary outcome measure	Action Research Arm Test (ARAT).
Secondary outcome measures	ARAT at 3 and 12 months, Nine Hole Peg Test; biomechanical assessment of spasticity; motor impairment (Motricity Index and grip strength by dynamometer); UL pain (numerical rating scale). Assessment of patient-selected UL goals; disability (Barthel ADL Index); and quality of life (Stroke Impact Scale and EQ-5D).
Overall study start date	01/02/2005
Completion date	28/02/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	390
Key inclusion criteria	1. Age over 18 years 2. At least 1 month since stroke 3. Upper limb (UL) spasticity (modified Ashworth scale >2 at the elbow and/or spasticity at wrist or shoulder 4. Reduced UL function but with some general function retained (Action Research Arm Test [ARAT] score 4-56)
Key exclusion criteria	1. Significant speech or cognitive impairment which will impede assessment. Participants must be able to understand and complete assessments (Abbreviated Mental Test Score [AMTS] >5 and Sheffield Aphasia score above age defined cut offs for receptive dysphasia). 2. Other significant upper limb impairment e.g. fracture or frozen shoulder within six months, severe arthritis, amputation 3. Evidence of contracture 4. Female patients who are pregnant or lactating or who are not willing to take adequate precautions against pregnancy for the duration of the study 5. Diagnosis likely to interfere with rehabilitation or outcome assessments e.g. registered blind, malignancy 6. Other diagnosis which may contribute to upper limb spasticity e.g. multiple sclerosis, cerebral palsy 7. Contraindications to intramuscular injection 8. Religious objections to blood products (botulinum toxin contains human albumen) 9. Contraindications to botulinum toxin which include bleeding disorders, myasthenia gravis and concurrent use of aminogycosides 10. Use of botulinum toxin to the upper limb in the previous three months 11. Known allergy or hypersensitivity to any of the test compounds
Date of first enrolment	01/02/2005
Date of final enrolment	28/02/2009

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

School of Population & Health Sciences

Newcastle upon Tyne
NE2 4HH
United Kingdom

Sponsor information

The Newcastle Upon Tyne Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre

The Newcastle upon Tyne Hospitals NHS Trust
Freeman Hospital
Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
England
United Kingdom

Website	http://www.newcastle-hospitals.org.uk/
"ROR"	https://ror.org/05p40t847

Funders

Funder type

Industry

NIHR Health Technology Assessment Programme - HTA (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/05/2010		Yes	No