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.
Our aim in this study is comparison of the Botulinum toxin type A with oral Tizanidine in the treatment of spasticity due to stroke. The key inclusion criteria was to have a history of cerebral stroke for at least 3 months ago and the key exclusion criteria was to have a systemic disorder. In a randomized unicentral single blinded study 68 patients from both genders with upper limb spasticity referring to the neurology clinic of Emam Reza hospital, Tabriz, Iran, were assigned in two equally-sized groups to receive oral Tizanidine or intra-muscular Botulinum toxin. For the first group, Tizanidine will be started with 2 mg/day and added 2 mg/week until the dose of 16 mg/day in week 16. Patients will be assessed in week 16. In Botulinum group, patients will be injected two doses of Botulinum into the upper limb muscles with a 3-4 month time gap. Limb spasticity in Ashworth scale and Limb function improvement in ARAT scale in the start of the study for all the patients, week 16 (for Tizanidine) and 3 months after the last injection (for Botulinum) will be measured and the results will be compared within and between the groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012112411563N1
Registration date:2012-12-06, 1391/09/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-12-06, 1391/09/16
Registrant information
Name
Mohammad Yazdchi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1658 4153
Email address
yazdchim@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2012-04-04, 1391/01/16
Expected recruitment end date
2012-12-06, 1391/09/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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.
Public title
Comparison of the Botulinum toxin type A with oral Tizanidine in the treatment of spasticity due to stroke
Purpose
Treatment
Inclusion/Exclusion 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)
Age
From 35 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Vice chancellor for research, Tabriz University of Medical Sciences, Daneshgah Square
City
Tabriz
Postal code
Approval date
2012-04-03, 1391/01/15
Ethics committee reference number
9122
Health conditions studied
1
Description of health condition studied
Spasticity due to cerebral stroke
ICD-10 code
I69.3
ICD-10 code description
Sequelae of cerebral infarction
Primary outcomes
1
Description
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
2
Description
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
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
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.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Neurology clinic of Emam Reza hospital
Full name of responsible person
Mohammad Yazdchi
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Alireza Ostad Rahimi
Street address
Vice chancellor for research, Tabriz University of Medical Sciences, Daneshgah square
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Zahra Ghasemi
Position
Neurology resident
Other areas of specialty/work
Street address
Neurology ward, Imam Reza hospital, Golgasht st.
City
Tabriz
Postal code
Phone
+98 41 1335 7310
Fax
Email
nq.neurologist@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Yazdchi
Position
Associateprofessor/Neurologist
Other areas of specialty/work
Street address
Emam Reza hospital, Golgasht ave.
City
Tabriz
Postal code
Phone
+98 41 1335 7310
Fax
Email
yazdchim@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Hemmati
Position
General physician
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
mehdi.hemmati@rocketmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)