The aim of this study was to investigate the effect of combination therapy of baclofen and Trihexyphenidyl in the early treatment of spasticity following trauma.
Design
Clinical trials with 3 groups, factorial groups, Double blind, randomized, phase 2 on 90 patients. Using random digits, a third party will assign them to one of three groups
Settings and conduct
Location: ICU ward of Bahonar Hospital in Kerman
The tablets will be given by oral Gavage . Due to the patient's anesthesia, one side will be blind. The treatment regimen is also given by the nurse and therefore the Spasm assessment. Physician
will also be unaware of the treatment protocol. Therefore, another side is considered blind.
Participants/Inclusion and exclusion criteria
inclusion Criteria : Patients with acute onset of spasm following trauma in patients with concussion
exclusion Criteria : 1. GCS level 3 of 15.
2. Severe drug side effects following baclofen or Trihexyphenidyl .
3. History of severe hypersensitivity to baclofen or Trihexyphenidyl
Intervention groups
The first group received only baclofen with an initial dose of 5 mg three times a day with an increase of 5 mg every three days to a maximum dose of 25 mg three times a day if no response.
The second group received Trihexyphenidyl 1 mg per day by increasing the dose of Trihexyphenidyl up to a maximum of 8 mg per day if there is no response and the initial dose of baclofen remains constant in addition to baclofen.
The third group received baclofen and Trihexyphenidyl with the condition that the initial dose of Trihexyphenidyl remained constant and the increase in baclofen dose if no response was similar to the first group.
Main outcome variables
Spasm in the muscles of the wrist flexor muscles on one side
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200415047096N1
Registration date:2020-09-09, 1399/06/19
Registration timing:retrospective
Last update:2020-09-09, 1399/06/19
Update count:0
Registration date
2020-09-09, 1399/06/19
Registrant information
Name
pedram arfa
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3223 5011
Email address
parfaf@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-31, 1399/01/12
Expected recruitment end date
2020-07-19, 1399/04/29
Actual recruitment start date
2020-04-08, 1399/01/20
Actual recruitment end date
2020-08-19, 1399/05/29
Trial completion date
2020-08-22, 1399/06/01
Scientific title
Effects of Combination Therapy of Baclofen & Trihexyphenidyl on Early Onset Spasticity in Post Traumatic Brain Injury Patients
Public title
Effects of Combination Therapy of Baclofen & Trihexyphenidyl on Spasticity in Brain Injury Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Early Onset Spasticity in Post Traumatic Brain Injury Patients
Exclusion criteria:
The level of consciousness (GCS) is equal to 3 out of 15
Severe drug side effects following baclofen or Trihexyphenidyl
History of severe allergy to baclofen or Trihexyphenidyl
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
90
Actual sample size reached:
90
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, patients randomly divided in three groups (30 patients in each group) using random allocation sequence with SAS statistical software. According to this method, a simple randomization list product and patients` involvement in each group determine base on order entry. we used sequentially numbered sealed opaque for allocation concealment.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study was double blinded study. The tablets will be given by oral Gavage. Due to the patient's anesthesia, one side will be blind. The treatment regimen is also given by the nurse and therefore the Spasm assessment Physician will also be unaware of the treatment protocol.
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of kerman University of Medical Sciences
Street address
Kerman,The beginning of Haft Bagh Alavi Road, Kerman University of Medical Sciences Campus
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2020-04-24, 1399/02/05
Ethics committee reference number
IR.KMU.AH.REC.1396.1770
Health conditions studied
1
Description of health condition studied
Spasticity in Post Traumatic Brain Injury Patients
ICD-10 code
Dyskinetic
ICD-10 code description
G80.3
Primary outcomes
1
Description
Spasm in the muscles of the wrist flexor muscles on one side
Timepoint
Spasm in the flexor muscles of the wrist on one side (left hand) is recorded on First day, third day, seventh day, first month, third month, and sixth month after administration.
Method of measurement
Modified Ashworth Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In addition to baclofen, Trihexyphenidyl 1 mg per day with increasing dose of Trihexyphenidyl up to a maximum of 8 mg per day if no response and the initial dose of baclofen remains constant
Category
Treatment - Drugs
2
Description
Control group: Only baclofen is taken with an initial dose of 5 mg three times a day with an increase of 5 mg every three days to a maximum dose of 25 mg three times a day if no response.
Category
Treatment - Drugs
3
Description
Intervention group: Baclofen and Trihexyphenidyl provided that the initial dose of Trihexyphenidyl remains constant and the dose of baclofen increases if the first group does not respond similarly.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Bahonar Hospital in Kerman
Full name of responsible person
Pedram Arfa
Street address
Gharani
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
parfaf@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abbas Pardakhti
Street address
Somayeh crossroad
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 3815
Email
kmu_research@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Pedram Arfa
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurosurgery
Street address
Gharani
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
parfaf@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mohsen Shahba
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
GHarani
City
kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
mshahba@kmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Pedram Arfa
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurosurgery
Street address
Gharani
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
parfaf@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
At the end of the study, some of the information, including the effect of a combination of baclofen and Trihexyphenidyl (with two different doses) on the early treatment of spasm following trauma in stroke patients, was shared with health workers.
When the data will become available and for how long
2 months after data analysis
To whom data/document is available
Health researchers
Under which criteria data/document could be used
In order to use the results and during the written request
From where data/document is obtainable
Pedram Arfa- Email
What processes are involved for a request to access data/document