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Comparison of the Botulinum toxin type A with oral Tizanidine in the treatment of spasticity due to stroke

Comparison of the efficacy of intra-muscular Botulinum toxin type A with oral Tizanidine in the treatment of upper limb spasticity and functional improvement due to cerebral stroke.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT2012112411563N1
Enrollment
68
Registered
2012-12-06
Start date
2012-04-04
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spasticity due to cerebral stroke. Sequelae of cerebral infarction

Interventions

Intervention 1: For Tizanidine group: Tizanidine will be started with 2 mg/day orally and added 2 mg/week until the dose of 16 mg/day in week 16. Intervention 2: In Botulinum group, patients will be
Treatment - Drugs
For Tizanidine group: Tizanidine will be started with 2 mg/day orally and added 2 mg/week until the dose of 16 mg/day in week 16.
In Botulinum group, patients will be injected two doses of Botulinum (not more than 1000 units/dose) into the upper limb muscles with a 3-4 month time gap.

Sponsors

Tabriz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
35 Years to 70 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: (to have a history of cerebral stroke for at least 3 months ago; severity of spasticity more than 2 in Ashworth scale; to be older than 35 years old) Exclusion criteria: (patients with impairment in level or content of consciousness; to have systemic disorders such as Diabetes, hyperthyroidism, electrolyte disorders, renal failure; to be older than 70 years old)

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Limbs Spasticity. Timepoint: in the start of the study for all the patients, week 16 (for Tizanidine) and 3 months after the last injection (for Botulinum). Method of measurement: Based on Ashworth scale.;Limb functional improvement. Timepoint: in the start of the study for all the patients, week 16 (for Tizanidine) and 3 months after the last injection (for Botulinum). Method of measurement: Based on ARAT scale.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactZahra Ghasemi

Tabriz University of Medical Sciences

nq.neurologist@yahoo.com+98 41 1335 7310

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026