Objectives:The aim of this study was to evaluate subacromial injection of ketorolac and compared it with steroids in patients with impingement syndrome shoulder.
Design:The sample size is 105 patients. In a clinical trial of 105 patients of both sexes with diagnosis of shoulder pain and shoulder impingement syndrome were randomly included in three groups.
Setting and conduct: For the first group ketorolac, second group triamcinolone and betamethasone LA for third group was injected.
Participants including major eligibility criteria: Inclusion criteria: all people with shoulder pain referred to orthopedic clinics and diagnostic imaging in the diagnosis of shoulder impingement syndrome has been laid for them and their consent to participate in the study. Exclusion criteria: patients with all of the diagnosis except impingement syndrome; Do not go to the next follow up; do not have a history of shoulder dislocation or fracture or a systemic disease that affects the joint and soft tissue .
Intervention: all patients will be injected with posterior Approach.
Main outcome measures: For all patients, the results and the variables included pain intensity, functional at weeks 0, 2, 4 and 6 week will be recorded and compared between the groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017042927797N2
Registration date:2017-06-07, 1396/03/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-06-07, 1396/03/17
Registrant information
Name
Masoud Bahrami Ferydoni
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3225 6285
Email address
m.bahrami@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology, Babol University of Medical Sciences
Expected recruitment start date
2016-10-03, 1395/07/12
Expected recruitment end date
2017-04-01, 1396/01/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of subacromial Ketorolac, betamethazone LA and triamcinolon injection in treatment of impingement syndrome
Public title
Comparison of subacromial Ketorolac, betamethazone LA and triamcinolon injection in treatment of impingement syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: all people with shoulder pain referred to orthopedic clinics and diagnostic imaging in the diagnosis of shoulder impingement syndrome has been laid for them and their consent to participate in the study. Exclusion criteria: patients with all of the diagnosis except impingement syndrome; Do not go to the next follow up; do not have a history of shoulder dislocation or fracture or a systemic disease that affects the joint and soft tissue .
Age
No age limit
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)
Double 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 Babol University of Medical Sciences
Street address
Babol University of Medical Sciences, Ganjafrooz Street, Babol, Mazandaran, Iran
City
Babol
Postal code
Approval date
2017-01-31, 1395/11/12
Ethics committee reference number
MUBABOL.HIR.REC.1395.112
Health conditions studied
1
Description of health condition studied
Impingement syndrome of shoulder
ICD-10 code
M75.4
ICD-10 code description
Impingement syndrome of shoulder
Primary outcomes
1
Description
Determine the function of the patient
Timepoint
Before injection, weeks 2, 4 and 6 after injection
Method of measurement
By Oxford Shoulder Score questionnaire
2
Description
Patient pain severity
Timepoint
Before injection, weeks 2, 4 and 6 after injection
Method of measurement
By Visual Analogus Scale questionnaire
Secondary outcomes
1
Description
Tendon Rupture
Timepoint
weeks 2, 4 and 6 after injection
Method of measurement
Physical Examination
2
Description
Injection site infection
Timepoint
weeks 2, 4 and 6 after injection
Method of measurement
Observation
Intervention groups
1
Description
In Group A subacromial ketorolac injection with a posterior approach will be done.
Category
Treatment - Drugs
2
Description
In Group B subacromial Triamcinolon injection with a posterior approach will be done.
Category
Treatment - Drugs
3
Description
In Group C subacromial Betamethazon LA injection with a posterior approach will be done.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Babol Shahid Beheshti Hospital
Full name of responsible person
Dr. Masoud Bahrami Ferydoni
Street address
Babol University of Medical sciences, Ganjafrooz street, Babol, Iran
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor of Reaserch and Technology, Babol University of Medical Sciences
Full name of responsible person
Dr.Aliakbar Moghaddamnia
Street address
Babol University of Medical Sciences, Ganjafrooz Street, Babol, Iran
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor of Reaserch and Technology, Babol 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
Babol University of Medical Sciences
Full name of responsible person
Dr.Hamed Abolhassani
Position
Resident of Orthopedic
Other areas of specialty/work
Street address
Babol University of Medical Sciences, Ganjafrooz Street, Babol, Iran
City
Babol
Postal code
Phone
+98 11 3219 7667
Fax
Email
bcrdc90@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Masoud Bahrami Frydoni
Position
Assistant Professer of Orthopedic
Other areas of specialty/work
Street address
Babol University of Medical Sciences, Ganjafrooz Street, Babol, Iran
City
Babol
Postal code
Phone
+98 11 3219 7667
Fax
Email
Dr bahrami865@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Hamed Abolhasani
Position
Resident of Orthopedic
Other areas of specialty/work
Street address
Babol University of Medical Sciences, Ganjafrooz Street, Babol, Iran
City
Babol
Postal code
Phone
+98 11 3225 6285
Fax
Email
bcrdc90@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)