Protocol summary

Summary
In this clinical trial study, patients with knee osteoarthritis who will come to physical medicine and rehab department were selected. Patients have tenderness in Pesanserin, and other normal aspect in physical examination like valgus stress test, are eligible to psrticipate in this study.these pstients will be randomized into two groups.the total number of patients are 30, with 15 in each group. In both the diagnosis of Pesanserin bursitis will be confirmed with sonography. In the firs group corticostroid injection will be done under sonography guidance and in the second, blinding. Pain score will be evaluated with VAS and WOMAC questionnar in the first visit and 2weeks later as follow up.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015110824621N2
Registration date: 2016-01-20, 1394/10/30
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-01-20, 1394/10/30
Registrant information
Name
Tannaz Ahadi
Name of organization / entity
Iran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 8871 8207
Email address
ahadi.t@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2015-11-22, 1394/09/01
Expected recruitment end date
2016-07-22, 1395/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Corticostroid Injection With or Without Sonography Guided in Pesanserin Bursit Tendinitis in Knee Ostoartheritis Patients
Public title
The Effect of Corticostroid Injection With or Without Sonography Guided in Pesanserin Bursit Tendinitis in Knee Ostoartheritis Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Older than 18y olders; Pesanserin Exculosion criteria: Younger than 18y; Fracture; Colateral ligament or minisc injury; Pregnancy; History of allergy to corticostroid injection; Poor control diabet; Inferction in a burse site
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Iran University of Medical Sciences
Street address
Tehran,Hemat Highway
City
Tehran
Postal code
Approval date
2015-06-22, 1394/04/01
Ethics committee reference number
Ir.iums.rec.1394.9311524004

Health conditions studied

1

Description of health condition studied
Pesanserin Tendonitis Bursit
ICD-10 code
M70.5
ICD-10 code description
Other bursitis of knee

Primary outcomes

1

Description
Relife knee Pain
Timepoint
2weeks After Injection
Method of measurement
VAS-WOMAC

Secondary outcomes

empty

Intervention groups

1

Description
Ampul Triamcinolone Injection in Pes Anserin Bursitis Without Sono Guided
Category
Treatment - Drugs

2

Description
Ampul Triamcinolone Injection in Pes Anserin Bursitis With Sono Guided
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Firoozgar Hospital
Full name of responsible person
Dr Sarvenaz Zavarehi
Street address
Beh Afarin St,Valiasr Squre
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sience
Full name of responsible person
Dr Tannaz Ahadi
Street address
Hemat highway.Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sience
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
Iran Medical Univercity
Full name of responsible person
Dr.Tannaz Ahadi
Position
Assistant Professor
Other areas of specialty/work
Street address
Tehran,Hemmat High way,Iran Medical Univercity
City
Tehran
Postal code
Phone
+98 21 8871 6008
Fax
+98 21 8871 6008
Email
Tannaz_ahadi@Yahoo.com
Web page address
Www.rehabblogfa.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran Medical Univercity
Full name of responsible person
Dr Sarvenaz Zavarehi
Position
Physical Medicine And Rehabilitation Resident
Other areas of specialty/work
Street address
Tehran,Hemat Highway
City
Tehran
Postal code
Phone
+98 21 8670 0000
Fax
Email
sarvionline@yahoo.com tannaz.ahadi@yahoo.cim
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iran medical univercity
Full name of responsible person
Dr sarvenaz zavarehi
Position
Docters degree
Other areas of specialty/work
Street address
Tehran
City
Tehran
Postal code
Phone
+98 21 8670 0000
Fax
Email
sarvionline@yahoo.com tannaz.ahadi@yahoo.com
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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