Comparison of the short-term effects of subacromial injection of methylprednisolone with ketorolac in improving shoulder movements, reducing pain and improving performance in patients with impingement syndrome referred to Imam Khomeini Hospital Complex (IKHC) in Tehran in 2023
Design
In this study, patients are divided into two groups after being admitted to the clinic and undergoing paraclinical examinations and confirming the diagnosis of impingement syndrome.
A group is prepared for subacromial injection of methylprednisolone and a group for subacromial injection of ketorolac.
Settings and conduct
Patient's demographic information (age, sex, history of previous illness or surgery, drug use, duration of pain onset and limitation of movement, and its possible cause) are recorded. The amount of ROM under study and the amount of limitation of ROM are recorded based on the Oxford questionnaire.
Shoulder injection is performed in the operating room and the patient is discharged. After 3-month follow up, the aforementioned questionnaire is completed by returning. The answers are recorded and subjected to statistical analysis.
Participants/Inclusion and exclusion criteria
Patients with impingement syndrome with shoulder pain and limitation of active shoulder movements.
Age above 18 years
Intervention groups
Patient with shoulder impingment syndrome
Main outcome variables
Steroid injection is one of the non-surgical treatments for SIS. However, the process is yet unknown. Despite anti-inflammatory effects of these drugs, their potential side effect limits the application of this method over time. In this study, we aim to compare effects of ketorolac with regards to its fewer complication reports in SIS patients with Depomedrol.
General information
Reason for update
Acronym
SASI
IRCT registration information
IRCT registration number:IRCT20230625058584N1
Registration date:2023-07-03, 1402/04/12
Registration timing:prospective
Last update:2023-07-03, 1402/04/12
Update count:0
Registration date
2023-07-03, 1402/04/12
Registrant information
Name
reza omid
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7704 1848
Email address
dr_rezaomid66@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-01, 1402/05/10
Expected recruitment end date
2023-09-01, 1402/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing Short-term Effects of Subacromial Injection with Ketorolac and Methylprednisolone in Rotator Cuff Injury Patients
Public title
comparison of short-term effects of subacromial injection of ketorolac and steroids in rotator cuff muscle injury
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients diagnosed with Shoulder Impingement Syndrome (SIS) and shoulder pain and reduced range of motion of affected shoulder
Older than 18 years
Exclusion criteria:
Patients diagnosed with frozen shoulder
Other pathologies associated with shoulder pain
Rotator cuff tearing
Shoulder and scapular fracture
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
In this research, patients with impingement syndrome are categorized into two groups following their admission to the clinic and undergoing paraclinical evaluations to confirm their diagnosis. One group is prepared for subacromial injection of methylprednisolone, while the other receives subacromial injection of ketorolac. At the scheduled time, patients visit the operating room as outpatients, where the injection is administered to them.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of Tehran University of Medical Scinece
Street address
Imam Khomeini Hospital Complex- Tehran University of Medical Science
City
Tehran
Province
Tehran
Postal code
Approval date
2018-04-22, 1397/02/02
Ethics committee reference number
IR.TUMS.IKHC.REC.1401.315
Health conditions studied
1
Description of health condition studied
Subacromial Impingement Syndrome
ICD-10 code
M75.4
ICD-10 code description
Impingement Syndrome of Shoulder
Primary outcomes
1
Description
Oxford Shoulder Score (OSS)
Timepoint
3 months
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Single subacromial injection of Depomedrol (methylprednisolone 40 mg/mL) mixed with 1 mL of Lidocaine Hydrochloride 2% (Sinadarou)
Category
Treatment - Drugs
2
Description
Control group: single subacromial injection of Ketorolac Tromethamine ( 30mg/mL) mixed with 1 mL of Lidocaine Hydrochloride 2%