Comparison of the effectiveness of phenol with botulinum toxin injection in lower extremities spasticity
Design
This clinical trial will have two intervention groups, community-based and pragmatic, with parallel groups, one-blind, randomized.
Settings and conduct
This randomized clinical trial will be carried out on referrers to physical and rehabilitation clinics of Shiraz University of Medical Sciences. lower limb spastic patients will be randomly divided into two groups
. The randomized blocking method will be used to randomize the patients.
Participants/Inclusion and exclusion criteria
Entry curricula:
Completion and signing consent form,
People aged 10 to 70 years,
passing 5 months of injury,
Limited range of motion of the lower limb;
Exclusion criteria :
coagulation disorders,
use of anticoagulant drugs,
severe cardiovascular problems,
inability to communicate and complete questionnaires,
history of allergy and allergic reaction to used drugs
Intervention groups
Group A: 6% phenol injection in aqueous solution for each muscle . Group B treatment: injection of botulinum toxin A in sterile saline solution to a concentration of 100 units per ml and for people with a low weight ,50 units per ml.
Main outcome variables
Improvement of spasticity according to the Ashworth criteria
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170826035914N2
Registration date:2019-04-12, 1398/01/23
Registration timing:retrospective
Last update:2019-04-12, 1398/01/23
Update count:0
Registration date
2019-04-12, 1398/01/23
Registrant information
Name
Azadeh hajihosseini
Name of organization / entity
shiraz university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 71 3231 9040
Email address
hajihosseini@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-03-21, 1396/01/01
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of phenol with botulinum toxin injection in lower extremities spasticity
Public title
Comparison of the effectiveness of phenol with botulinum toxin injection in lower extremities spasticity
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Complete and sign the consent form
People aged 10 to 70 years
Pass 5 months of damage
limited range of motion of lower limb(Ankle,knee,pelvic)
Exclusion criteria:
coagulation disorder
use of anticoagulant drugs
cardiopulmonary disease
Failure to communicate and questionnaire completion
history of allergy and allergic reaction to used drugs
Age
From 10 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
block randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients are unaware of the type of injectable substance and are randomly divided into two groups A and B.
The physician does not know the type of injectable drug of each group and the drug is prepared by someone else.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Faghihi hospital، Karimkhan Ave
City
Shiraz
Province
Fars
Postal code
7134844119
Approval date
2017-05-22, 1396/03/01
Ethics committee reference number
IR.SUMS.MED.REC.1396.24
Health conditions studied
1
Description of health condition studied
Lower limbs spasticity
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Spasticity score accordinge to ashworth scale
Timepoint
Before intervention، 24 hour، 3 weeks after intervention
Method of measurement
Spasticity score accordinge to ashworth scale
Secondary outcomes
1
Description
range of motion of lower limbs
Timepoint
Before intervention, 24 hours and 3 weeks after intervention
Method of measurement
Goniometer
Intervention groups
1
Description
Intervention group: First, the injection of phenol 6% in water solution for each muscle is based on the severity of the spasticity, muscle size and body weight of the patient. The muscles are selected on the basis of stretch and touch or electromyography, and the toxin is injected by the thin needle (Gage 27) at the maximal muscle bulk.
Category
Rehabilitation
2
Description
The second intervention group: botulinum toxin A injection in sterile saline solution up to a concentration of 100 units per ml and for individuals with a low weight, 50 units per milliliter. A botulinum toxin dose selection is based on muscle size, degree of spasticity, and body weight. The muscles are selected on the basis of stretch and touch or electromyography, and the toxin is injected by the thin needle (Gage 27) at the maximal muscle bulk.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Chamran hospital
Full name of responsible person
Azadeh Hajihosseini
Street address
Chamran BLV, Chamran hospital
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3624 0101
Email
hajihosseini@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Basir Hashemi
Street address
Karimkhan Blv, Shiraz university of medical sciences
City
Shiraz
Province
Fars
Postal code
۱۴۳۳۶ - ۷۱۳۴۸
Phone
+98 71 3230 5410
Email
president@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Hamidreza Farpoor
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Kharimkhan Blvd, Faghihi Hospital
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 713235108799
Email
Faghihihsp@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hamidreza Farpoor
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Karimkhan Blvd, faghihi hospital
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 713235108799
Email
faghihihsp@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Azadeh Hajihosseini
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Karimkan Blvd, Faghihi hospital
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 32 3510 8799
Email
Faghihihsp@sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available