The purpose of this study is comparison of Dysport (abobotulinumA) injection with oral propranolol outcomes in treatment of essential hand tremor. Seventy eight patients coming to Dr Asadi's clinic in Imam Reza hospital or his office with moderate to severe essential hand tremor will be enrolled. Their tremor should not be due to other diseases or drugs and they should not have Dysport or propranolol contraindications. After taking an informed consent, they will be divided into two groups randomly by tossing. Group A (n=30) will receive a Dysport injection in forearm muscles. For group B (n=48) will be prescribed oral propranolol for 3 months. Before intervention, tremor severity will be assessed using tremor research group essential tremor rating assessment scale (TETRAS) and the short form 36 (SF-36) quality of life questionnaire will be answered by patients. Furthermore after 1, 2, 3 months, tremor severity will be assessed again and after 2 months, the second questionnaire will be answered. Finally the results will be analyzed. Evaluating researcher will not be informed about intervention type (single blinded). There is no placebo control group because of ethics considerations.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201607022415N2
Registration date:2016-08-22, 1395/06/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-08-22, 1395/06/01
Registrant information
Name
Bahador Asadi Khansari
Name of organization / entity
Army University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 2277 1487
Email address
peiman_asadi@ajaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Army university of medical sciences
Expected recruitment start date
2016-08-05, 1395/05/15
Expected recruitment end date
2017-01-20, 1395/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial: comparative effectiveness of oral propranolol and Dysport injection on tremor severity in essential hand tremor
Public title
Treatment of essential hand tremor: Dysport versus propranolol
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: essential hand tremor with severity equal or greater than 2 according to tremor research group essential tremor rating assessment scale (TETRAS) version 3.1 (paragraph 4); normal thyroid function test; age higher than 18 years;
exclusion criteria: drug induced tremor; pregnancy and lactation; allergy to cow milk protein; propranolol contraindications for example heart block, congestive heart failure, diabetes melitus, asthma and etc; history of botulinum injection in upper limb; recent botulinum injection in any part of body since 8 months ago; allergy to botulinum; history of myasthenia gravis or suspicious to myasthenia gravis; parkinson disease; use of anti-dopaminergic medications
Age
From 18 years old to 100 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
78
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 army university of medical sciences
Street address
ethics committee, army university of medical sciences, Etemadzade st, Fatemi st
City
Tehran
Postal code
Approval date
2016-08-01, 1395/05/11
Ethics committee reference number
الف/ج/18/9175
Health conditions studied
1
Description of health condition studied
essential hand tremor
ICD-10 code
G25.0
ICD-10 code description
Essential tremor
Primary outcomes
1
Description
hand tremor severity
Timepoint
before treatment, one and two and three months following the start of treatment
Method of measurement
tremor research group essential tremor rating assessment scale (TETRAS)
2
Description
quality of life
Timepoint
before treatment, two months following start of treatment
Method of measurement
short form 36 (SF-36) quality of life questionnaire
Secondary outcomes
1
Description
side effects
Timepoint
one and two and three months following start of treatment
Method of measurement
history taking
Intervention groups
1
Description
Dysport intramuscular injection in forearm 100-150 unit once
Category
Treatment - Drugs
2
Description
tablet propranolol 40-160 mg daily for 3 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Dr Asadi
Street address
third floor, Imam Reza hospital, Etemadzadeh street, Fatemi street
City
Tehran
2
Recruitment center
Name of recruitment center
Dr Bahador Asadi's office
Full name of responsible person
Mrs Kalimi
Street address
unit 9, third floor, No 24, alley 21, south Gandhi street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, army university of medical Sciences
Full name of responsible person
Dr Kamran Azma
Street address
Vice chancellor for research, Army university of medical sciences, Etemadzadeh street, Fatemi street
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, army 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
Army university of medical sciences
Full name of responsible person
Saeed Amiri
Position
researcher/MD
Other areas of specialty/work
Street address
Elites office, army university of medical sciences, Etemadzadeh street, Fatemi street
City
Tehran
Postal code
Phone
+98 21 8833 7920
Fax
Email
dr.saeed.amiri@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Army university of medical sciences
Full name of responsible person
Dr Bahador Asadi
Position
Neurologist/assistant professor
Other areas of specialty/work
Street address
third floor, Imam Reza hospital, Etemadzadeh street, Fatemi street
City
Tehran
Postal code
Phone
+98 21 8802 8350
Fax
Email
peimanasadi1353@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Army university of medical sciences
Full name of responsible person
Saeed Amiri
Position
researcher/MD
Other areas of specialty/work
Street address
Elites office, army university of medical sciences, Etemadzadeh street, Fatemi street
City
Tehran
Postal code
Phone
+98 21 8833 7920
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)