Comparison of the results of cast and bandage treatment methods on ankle sprain in patients
Design
Two arm parallel group randomised trial with non-blinded with control group
Settings and conduct
This study was designed as a clinical trial. After the approval of the plan in the research council of the university and after coordination with the emergency department, patients who referred to the Emergency Hospital of Poursina, who need medical treatment with ankle sprain, should enter the study within 6 months. Patients are examined and divided into two types according to severity of injury. In this study, sampling would be gradual sampling. Patients then, given that Types 1 and 2 are different, Typing 1 is outside the study and patients are classified according of clanton and mcgarvey to the severity of the ligaments to the cluster type 2, group 2, type A, which is intended in this study.
Participants/Inclusion and exclusion criteria
Include:
Type II-unstable ankle with positive anterior drawer test or positive talar tilt test or both
Group2- Athlete or high demand patient
Type A; negative radiographic stress test ;functional treatment
Exclude:
Patients with neuropathy (diabetes or other causes).
Patients with damaged organ varices
Diabetes
History of ankle fracture
Previous history of sprain and surgery
Patients requiring operation
Low demand
Patients with weakeness lower limb that increase effected on the other side
Intervention groups
Patients who type 2 in group 2, type A, are included in the study and randomly divided into two groups. For first group bandage is performed and for the second group short cast is performed.
Main outcome variables
Visual Analog Scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190529043760N1
Registration date:2019-06-12, 1398/03/22
Registration timing:registered_while_recruiting
Last update:2019-06-12, 1398/03/22
Update count:0
Registration date
2019-06-12, 1398/03/22
Registrant information
Name
Kamran Asadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3323 2200
Email address
kamran_asadi@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-21, 1398/02/01
Expected recruitment end date
2019-07-22, 1398/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The result of comparing cast and bondage methods treatment of ankle sprain in the patients
Public title
Study of cast and bondage methods treatment of ankle sprain in the patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Type II-unstable ankle with positive anterior drawer test or positive talar tilt test or both
Group2- Athlete or high demand patient
Type A; negative radiographic stress test ;functional treatment
Exclusion criteria:
Patients with neuropathy (diabetes or other causes).
Patients with damaged organ varices
Diabetes
History of ankle fracture
Previous history of sprain and surgery
Patients requiring operation
Low demand
Patients with weakeness lower limb that increase effected on the other side
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
78
Randomization (investigator's opinion)
Randomized
Randomization description
The sampling method of this study was gradual in the patients' group so that who referred to the orthopedic department of Poursina Hospital, if they had the criteria and conditions for entering the study, and they had satisfied in the research based on four random blocks, according to The sample size will be about 40 blocks. Firstly, in a envelope and stamped in the orthopedic research center, it will be determined that randomization is assigned to two groups A (cast) and B (bandage). The research group will not be of any benefit in selecting the samples.
Blinding (investigator's opinion)
Not 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 guilan University of Medical Sciences
Street address
Research and Technology Center of Guilan University of Medical Sciences,in front of 17th shahrivar hospital,Namjoo Street, shahid Siadati St
City
Rasht
Province
Guilan
Postal code
4144666949
Approval date
2019-04-13, 1398/01/24
Ethics committee reference number
ir.gums.rec.1398.025
Health conditions studied
1
Description of health condition studied
ankle sprain
ICD-10 code
S93.4
ICD-10 code description
Sprain of ankle
Primary outcomes
1
Description
pain
Timepoint
3,6,12 weeks
Method of measurement
visual analogue scale
Secondary outcomes
1
Description
Movement restriction
Timepoint
3,6,12 weeks
Method of measurement
physical exam
Intervention groups
1
Description
Intervention group: The ankle plastering for 3 weeks
Category
Treatment - Devices
2
Description
Control group: the ankle bandage for 3 weeks
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Poursina Hospital
Full name of responsible person
Kamran Asadi
Street address
Poursina Hospital, Namjoo St, Rasht
City
Rasht
Province
Guilan
Postal code
41937-13194
Phone
+98 13 3332 2444
Fax
+98 13 3333 9842
Email
poursina_pr@yahoo.com
Web page address
http://www.gums.ac.ir/poursina/Home
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Shademan Nemati
Street address
shahid Siadati St., Namjoo Ave.,
City
Rasht
Province
Guilan
Postal code
41937-13194
Phone
+98 13 3333 5821
Fax
+98 13 3333 6395
Email
research@gums.ac.ir
Web page address
http://www.gums.ac.ir/research/default-303.aspx
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht 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
Rasht University of Medical Sciences
Full name of responsible person
Kamran Asadi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Poursina Hospital, Namjoo Ave.
City
Rasht
Province
Guilan
Postal code
4193713194
Phone
+98 13 3323 2200
Fax
Email
kamran_asadi@gums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Kamran Asadi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Poursina Hospital, Namjoo Ave.
City
Rasht
Province
Guilan
Postal code
4193713194
Phone
+98 13 3323 2200
Fax
Email
kamran_asadi@gums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Kamran Asadi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Poursina Hospital, Namjoo Ave.
City
Rasht
Province
Guilan
Postal code
4193713194
Phone
+98 13 3323 2200
Fax
Email
kamran_asadi@gums.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