Protocol summary

Summary
This is a trial on patients with frozen shoulder in order to compare joint injection, physiotherapy and both in a clinic in Sari, Iran. Frozen shoulder is defined as pain and limitation of motion in glenohomeral joint at least 50% in at least two directions. Patients with frozen shoulder for less than one year, the age 18, with total score 30 for SPADI (Shoulder Pain and Disability Index) will entered. Patients with inflammatory arthropathy, degenerative, metabolic (except diabetes), infectious disorders, CVA or fracture or who had received steroid injection or physiotherapy during 6 month ago will exclude. After getting subscription, we will have three groups (1-2-3) that will be divided to 2 blocks (diabetic and non diabetic) with 35 patients in each group randomly, corticosteroid injection in the first group (20 mg triamcinolone in Subacromial bursa and 40 mg triamcinolone in shoulder joint with posterior approach by rheumatologist), physiotherapy in second group (10 sessions shoulder physiotherapy by a physiotherapist for 2 weeks) and both in the third group. Doing simple exercises at home and using Acetaminophen will be recommended in all groups. The patients are evaluated in the weeks of 0, 6 and 24. Intensity of pain and disability are determined according to SPADI questionnaire and physical examination in each visit. Side effects will be recorded in the group of steroid injection.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138802011828N1
Registration date: 2009-07-15, 1388/04/24
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2009-07-15, 1388/04/24
Registrant information
Name
Maryam Mobini
Name of organization / entity
Mazandaran University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 15 1324 4142
Email address
mmobini@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences and Health services
Expected recruitment start date
2009-06-22, 1388/04/01
Expected recruitment end date
2010-08-23, 1389/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of corticosteroid injection, physiotherapy and combination therapy in frozen shoulder
Public title
Comparison of the effect of corticosteroid injection, physiotherapy and combination therapy in frozen shoulder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with adhesive capsulitis for less than one year, the age over18, total score 30 for SPADI Exclusion criteria: Patients with frozen shoulder accompanied with inflammation, degenerative, metabolic (except diabetes), infectious disorders, CVA or fracture or who had received steroid injection or physiotherapy during 6 month ago.
Age
From 18 years old to 75 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 105
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
Mazandaran University of Medical Sciences and Health Services
Street address
Imam Sq, Joybar 3way, Start of valiye asr highway
City
Sari
Postal code
Approval date
empty
Ethics committee reference number
88-36

Health conditions studied

1

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

Primary outcomes

1

Description
pain
Timepoint
before intervention and 6 and 24 weeks after intervention
Method of measurement
VAS

2

Description
disability
Timepoint
before intervention and 6 and 24 weeks after intervention
Method of measurement
SPADI questionarie

Secondary outcomes

1

Description
passive flexion
Timepoint
before intervention and 6,24 weeks after intervention
Method of measurement
Goniometer

2

Description
passive abdaction
Timepoint
before intervention and 6,24 weeks after intervention
Method of measurement
Goniometer

3

Description
passive external rotation
Timepoint
before intervention and 6,24 weeks after intervention
Method of measurement
Goniometer

Intervention groups

1

Description
In corticosteroid group: 20 mg triamcinolone +1.5 cc lidocaine 2% in Subacromial bursa and 40 mg triamcinolone+ 3cc lidocaine 2% in shoulder joint with posterior approach by rheumatologist
Category
Treatment - Drugs

2

Description
In physiotherapy group: 10 sessions shoulder physiotherapy by a physiotherapist for 2 weeks
Category
Treatment - Devices

3

Description
In third group: 20 mg triamcinolone +1.5 cc lidocaine 2% in Subacromial bursa and 40 mg triamcinolone+ 3cc lidocaine 2% in shoulder joint with posterior approach by rheumatologist after one week 10 sessions shoulder physiotherapy by a physiotherapist for 2 weeks
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Tuba clinic
Full name of responsible person
Marayam Mobini
Street address
Khazar bulvared
City
Sari

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences and Health Services
Full name of responsible person
Sayed jalal Hosseini mehr
Street address
Moalem sq.
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran University of Medical Sciences and Health Services
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
Mazandaran Univercity of medical sciences and Health services
Full name of responsible person
Motahareh Kheradmand
Position
Master of science nursing
Other areas of specialty/work
Street address
Moallem square
City
Sari
Postal code
Phone
+98 15132612458
Fax
Email
elhamkheradmand2003@yahoo.com; kheradmnd@mazums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaranl univercity of medical sciences and Health services
Full name of responsible person
Maryam Mobini
Position
Romatologist
Other areas of specialty/work
Street address
Razi street - Imam Khomani hospital
City
Sari
Postal code
Phone
+98 15 1324 4142
Fax
Email
mmobini50@yahoo.commmobini@mazums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences and Health Services
Full name of responsible person
Morteza Yaghubi
Position
Medecine student
Other areas of specialty/work
Street address
City
Sari
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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