Protocol summary

Summary
This study is a randomized clinical trial. The porpose of this study is to compare two treatment methods for patints diagnosed with acute ligament injuries. Data will collect using investigator made questionnaire for all patients aged between 15-45 and diagnosed with acute ligament injuries referred to the Emergency Clinic of Beheshti Hospital of Yasouj. On e hundred recruited patients randomly allocated to two groups. aged 15 to 45, no experience of old treatment, or history of romatoeid disease, getting injury less than 48 hrs, and exclusion criteria are: medical complications, and no complete adherence durin study. patiants in Control group will therat by immobilized building and patients in case group will threat by functional treatment . Patients are followed at six months intervals. results of treatment record at two weeks, six weeks, three months and six months later. The variables of pain, recurrence of symptoms, functional stability, swelling, tenderness, ecchymosis, joint mobility, back to work will evaluate by Medical students Internshipunder supervision of orthopedic specialist physician . Finally, the results will be compared.

General information

Acronym
treatment in ligament damaged
IRCT registration information
IRCT registration number: IRCT201102035619N2
Registration date: 2011-07-04, 1390/04/13
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-07-04, 1390/04/13
Registrant information
Name
Hamid Reza Ghafarian Shirazi
Name of organization / entity
Yasouj University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 74 1223 4850
Email address
ghafarian_h@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Yasouj University of Medical Sciences
Expected recruitment start date
2009-01-20, 1387/11/01
Expected recruitment end date
2011-05-22, 1390/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of stability and functional treatment in ligament damaged: a randomised clinical trial.
Public title
Stability versus functional treatment in ligament damage.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : getting injury in less than 48 hr; no history of acute injury to the ankle ligaments; no experience of treatment in other clinics; No history of rheumatoid disease; Exclusion criteria : medical complication; no complete adherence.
Age
From 15 years old to 45 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
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
Yasouj University Of Medical Sciences
Street address
Faculty of Medicine
City
Yasouj
Postal code
7591854593
Approval date
2008-04-11, 1387/01/23
Ethics committee reference number
870123/5

Health conditions studied

1

Description of health condition studied
Injury of muscle and tendon at ankle and foot level
ICD-10 code
s96
ICD-10 code description
Injury of muscle and tendon at ankle and foot level

Primary outcomes

1

Description
Pain
Timepoint
first week;sixth Week, third month; sixth month
Method of measurement
standard pain scalle questioner

2

Description
Joint Mobility
Timepoint
first week;sixth Week, third month; sixth month
Method of measurement
Orthoped Physisian Opinion

3

Description
Inflation
Timepoint
first week; sixth week; first month; sixth month
Method of measurement
examination

Secondary outcomes

1

Description
Recovery time
Timepoint
1 & 6 Weeks, 3 & 6 Monthes
Method of measurement
Ortopedic Physisisan Opinion

Intervention groups

1

Description
Patiants in control group will threat by immobilized building by cast for two weeks without -weight bearing and then physical therapy program begins. patients in trial group will threat by functional treatment. in this method of treatment, for the first 48 hours, patient's leg bandages, elastic wrist and then let functional brace with weight bearing , also physical therapy begins.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Martyr Mofateh Speciality clinic of Yasouj
Full name of responsible person
Dr Hamid Reza Mohamadi
Street address
Yasouj, Martyr Mofateh Street
City
Yasouj

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yasouj University Of Medical Sciences
Full name of responsible person
Dr Mohamad Zoladl
Street address
Research Deputy, Yasouj University Of Medical Sciences
City
Yasouj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj 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
Yasouj University of Medical Sciences
Full name of responsible person
Hamid Reza Ghafarian Shirazi
Position
Biostatistics PhD
Other areas of specialty/work
Street address
Faculty of Medicine
City
Yasouj
Postal code
Phone
+98 74 1223 0290
Fax
Email
اghafarian_h@razi.tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Dr hamid Reza Mohamadi
Position
Assistant Proffesor
Other areas of specialty/work
Street address
Faculty of Medicine
City
Yasouj
Postal code
Phone
+98 74 1223 0290
Fax
Email
Mohamadi.h@yums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Yasouj University Of Medical Sciences
Full name of responsible person
Dr Hamid Reza Ghafarian Shirazi
Position
Biostatistics PhD
Other areas of specialty/work
Street address
Faculty of Medicine
City
Yasouj
Postal code
Phone
Fax
Email
ghafarian.h@yums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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