Comparative study of the effectiveness of intra-articular injection of methylprednisolone at doses of 20 and 40 mg in patients aged 20 to 60 years with mild rotator cuff injury
Comparative study of the effectiveness of intra-articular injection of methylprednisolone with two doses of 20 and 40 mg in patients aged 20 to 60 years with mild rotator cuff injury
Design
This study is a randomized clinical trial with a parallel design, a single-blinded with a control group. This study is randomized, phase 2-3 study will be performed on 57 eligible patients. Random blocking is used for randomization and participants are assigned to two intervention groups and a control group.
Settings and conduct
This study, which will be conducted in Taleghani Hospital of Kermanshah, is a single-blinded one and the statistical analyst will be kept blind. Researchers and participants have no role in the process of randomization and assignment of intervention and control groups.
Participants/Inclusion and exclusion criteria
Include criteria: Patients aged 20 to 60 years; Detection of rotator cuff rupture to the extent of tendinosis.
Exclude criteria: Patients with more severe tears than tendinosis; history of fractures; Frozen shoulder; History of previous shoulder injections; Patients treated with oral or systemic injectable steroids; Concurrent lipoma or DJD joint injuries or concomitant shoulder instabilities
Intervention groups
In the first intervention group, patients will receive 40 mg of methylprednisolone by intra-articular injection. In the second intervention group, patients will receive 40 mg of methylprednisolone by intra-articular injection. In the control group, the same infrared physiotherapy will be performed with a wavelength of 1000 angstroms.
Main outcome variables
Shoulder function; Pain intensity; Shoulder function limitations
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N187
Registration date:2022-06-19, 1401/03/29
Registration timing:prospective
Last update:2022-06-19, 1401/03/29
Update count:0
Registration date
2022-06-19, 1401/03/29
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-06, 1401/04/15
Expected recruitment end date
2022-10-07, 1401/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the effectiveness of intra-articular injection of methylprednisolone at doses of 20 and 40 mg in patients aged 20 to 60 years with mild rotator cuff injury
Public title
Comparative study of the effectiveness of intra-articular injection of methylprednisolone at doses of 20 and 40 mg in patients with mild shoulder injury
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 20 to 60 years
Detection of rotator cuff rupture to the extent of tendinosis
Exclusion criteria:
Patients with more severe tears than tendinosis; history of fractures
Frozen shoulder
History of surgery
History of previous shoulder injections
Patients treated with oral or systemic injectable steroids
Concurrent lipoma or DJD joint injuries or concomitant shoulder instabilities
Age
From 20 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
Data analyser
Sample size
Target sample size:
57
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization using the blocking method with blocks in sizes 6 and 9. For randomization, the site https://www.sealedenvelope.com is used. All codes are recorded on paper and stored in specific envelopes. Each of the generated codes is kept separately inside the envelope and the secretary gives one of these envelopes to the patient before the patient enters the doctor's room. Accordingly, the next patient code is not predictable. The doctor determines which treatments to perform based on the patient's code. Only the physician performing the intervention will be aware of the code assigned to the patient. After evaluating the outcome, based on the patient's name, the collected information will be linked to the assigned code.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the statistical analyst will be kept blind. The code of the groups in the statistical and analysis software is not known to the analyst and only the main researcher is aware of it. Patients will also be aware of their treatment.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2022-03-13, 1400/12/22
Ethics committee reference number
IR.KUMS.MED.REC.1401.030
Health conditions studied
1
Description of health condition studied
rotator cuff tendinitis
ICD-10 code
S46.00
ICD-10 code description
Unspecified injury of muscle(s) and tendon(s) of the rotator cuff of shoulder
Primary outcomes
1
Description
Shoulder function
Timepoint
The beginning of the study, the third, sixth and twelfth weeks
Method of measurement
Using the UCLA shoulder rating scale
2
Description
Intensity of pain
Timepoint
The beginning of the study, the third, sixth and twelfth weeks
Method of measurement
Using visual pain scale (VAS)
3
Description
Shoulder function limitations
Timepoint
The beginning of the study, the third, sixth and twelfth weeks
Method of measurement
Simple shoulder test
Secondary outcomes
empty
Intervention groups
1
Description
In the first intervention group, patients will receive 40 mg of methylprednisolone by intra-articular injection.
Category
Treatment - Drugs
2
Description
In the second intervention group, patients will receive 40 mg of methylprednisolone by intra-articular injection.
Category
Treatment - Drugs
3
Description
In the control group, the same infrared physiotherapy will be performed with a wavelength of 1000 angstroms
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani Hospital
Full name of responsible person
Mohammad Mahdi Rajabi
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847167
Phone
+98 83 3836 7984
Email
Mahdirajabi1899@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Cyrus Jalili
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
cjalili@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mohammad Mahdi Rajabi
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Shahid Beheshti Boulevard, Taleghani Hospital
City
Kermanshah
Province
Kermanshah
Postal code
6715847167
Phone
+98 83 3836 7984
Email
Mahdirajabi1899@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Maziar Malekzadeh
Position
Faculty member of Kermanshah University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Shahid Beheshti Boulevard, Taleghani Hospital
City
Kermanshah
Province
Kermanshah
Postal code
6715847167
Phone
+98 83 3836 7984
Email
maziar.malekzadeh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mohammad Mahdi Rajabi
Position
medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Shahid Beheshti Boulevard, Taleghani Hospital
City
Kermanshah
Province
Kermanshah
Postal code
6715847167
Phone
+98 83 3836 7984
Email
Mahdirajabi1899@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD