Protocol summary

Summary
This study is a Clinical trial study on patients referred to rheumatology clinic in Kashan. The main inclusion criteria is an acute (less than 2 weeks), subacute or chronic (more than 2 weeks), mechanical, contributed with nocturnal pain and loss of movement in glenohomural joint.After primitive diagnosis the subjects were crossmatched upon sex, age, side of involvement, contributed problem such as Diabetes, Idiopathic and traumatic reason; then 40 mg triamcinolone acetonide (kenacort) and 40 mg methyl prednisolone (depomedrol) three times with interval of one week has been injected into joint space. The subjects were evaluated one and four weeks after the last injection; then scoring questionnaire of SPADI (shoulder pain and disability index) was filled and been analyzed

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201109061106N5
Registration date: 2011-09-11, 1390/06/20
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-09-11, 1390/06/20
Registrant information
Name
Zohreh Azarbad
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1555 2999
Email address
azarbad_zo@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical Sciences
Expected recruitment start date
2010-09-02, 1389/06/11
Expected recruitment end date
2011-04-21, 1390/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of triamcinolone acetonide and methyl prednisolone injection in shoulder Capsulitis treatment
Public title
Comparison of the effect of triamcinolone acetonide and methyl prednisolone injection in shoulder Capsulitis treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : patient with an acute (less than 2 weeks), subacute or chronic (more than 2 weeks), mechanical, contributed with nocturnal pain and loss of movement in glenohomural joint Exclusion criteria: patients who had intra-articular injections or oral steroids and physical therapy treatments received in the last 6 months,People who have had surgery, those with fracture or dislocation of the shoulder area, people with other diseases.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
N/A
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
Kashan University of Medical Sciences
Street address
5th Km of Ghotbe Ravandi Bulv.
City
Kashan
Postal code
8713781147
Approval date
2010-08-02, 1389/05/11
Ethics committee reference number
1208/1/5/29/پ

Health conditions studied

1

Description of health condition studied
Shoulder Capsulitis
ICD-10 code
M75.0
ICD-10 code description
Adhesive capsulitis of shoulder

Primary outcomes

1

Description
Pain
Timepoint
Before intervention, 1 and 4 weeks after intervention
Method of measurement
VAS

2

Description
Disability
Timepoint
Before intervention, 1 and 4 weeks after intervention
Method of measurement
SPADI(shoulder pain and disability index) questionarie

Secondary outcomes

empty

Intervention groups

1

Description
In triamcinolone acetonide group : 40 mg triamcinolone in shoulder joint three times within 1 week is injected by a rheumatologist
Category
Treatment - Drugs

2

Description
In Methyl Prednisolone group : 40 mg Methyl Prednisolone in shoulder joint three times within 1 week is injected by a rheumatologist
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Specialized Rheumatology Clinic of Shaheed Beheshti Hospital
Full name of responsible person
Dr.Kamal Esalatmanesh
Street address
5th Km of Ghotbe Ravandi Bulv.
City
Kashan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Gholam Ali Hamidi
Street address
5th Kilometer Ghotbe Ravandi Bulv.Kashan University of Medical Sciences
City
kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
kashan Univercity of Medical Sciences
Full name of responsible person
Dr.kamal Esalatmanesh
Position
Specialized rheumatology clinic
Other areas of specialty/work
Street address
5th Kilometer Ghotbe Ravandi Bulv.Beheshti Hospital
City
Kashan
Postal code
Phone
+98 36 1557 4415
Fax
Email
kamaleesalatmanesh@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan Univercity of Medical Sciences
Full name of responsible person
Dr.kamal esalatmanesh
Position
Specialized rheumatology clinic
Other areas of specialty/work
Street address
5th Kilometer Ravand Bulv. Beheshti Hospital
City
Kashan
Postal code
Phone
+98 36 1557 4415
Fax
Email
kamalesalatmanesh@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kashan Univercity of Medical Sciences
Full name of responsible person
Dr.Kamal Esalatmanesh
Position
Rheumatology Specialty
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
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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