Comparison the effect of Ketorolac sub acromial injection with methyl prednisolone in patient with shoulder impingement syndrome that refers to Isfahan university clinics in 2016-2017.
This study is a single-blind randomized clinical trial on patients with shoulder impingement syndrome. Patient history, examination and shoulder X-ray (Ap & lat) will be produced. Before treatment, we use the VAS score for severity of pain and Constant Score for shoulder Range of motion and function in all patients. The patients randomly divide into two groups A and B (based on random number table). We mark site of injection on patient's skin in sitting position. After sterilization of injection site, physiatrist by posterior approach. inject 60 mg ketorolac (about 2 ml) with 1 ml of lidocaine in subacromial space (group A) and 1 ml of methyl prednisolone with 1 ml of lidocaine in subacromial space(group B).Then VAS and Constant Score measured again for each patient one and three months later and analysis with SPSS 20. In this study significant P-value is considered less than 0/05.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017011231906N1
Registration date:2017-02-20, 1395/12/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-02-20, 1395/12/02
Registrant information
Name
Sahar mousavi Ghahfarokhi
Name of organization / entity
Isfahan University of Medical Sciences, Physical Medicine & Rehabilitation
Country
Iran (Islamic Republic of)
Phone
+98 913 300 2733
Email address
s.mousavi.md@gmail.com
Recruitment status
Recruitment complete
Funding source
Isfahan university of Medical Sciences
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2017-02-18, 1395/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of Ketorolac sub acromial injection with methyl prednisolone in patient with shoulder impingement syndrome that refers to Isfahan university clinics in 2016-2017.
Public title
The effect of ketorolac in the treatment of shoulder impingement syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1. age between 20 to 80 years old; 2. shoulder pain with the following positive test: the internal rotation resistance test (Neer test) and the Hawkins-Kennedy test; 3. approved participation in the research project
Exclusion criteria: 1. rheumatoid arthritis, osteoarthritis of the glenohumeral, complete tearing of the rotator cuff, shoulder girdle fracture, diabetes mellitus, infection and tumor; 2. change in treatment plan; 3. receiving subacromial injection from 8 weeks ago; 4. pregnant or plan to become pregnant; 5. there are risk factors for intra-articular injection, such as bleeding disorders or receiving anticoagulant; 6. contraindication for steroid injections / lidocaine and NSAID such as sensitivity to these drugs; 7. shoulder pain and dysfunction in the front side; 8. unavailability of patient after injection.
Age
From 20 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of medical science.
Street address
Hezar jarib street. Isfahan University of medical science.
City
Isfahan
Postal code
Approval date
2016-09-10, 1395/06/20
Ethics committee reference number
IR.MUI.REC.1395.3.596
Health conditions studied
1
Description of health condition studied
Shoulder impingment syndrom
ICD-10 code
M75.4
ICD-10 code description
Impingement syndrome of shoulder
Primary outcomes
1
Description
Pain
Timepoint
Admission, one and 3 months later
Method of measurement
Visual Analog Scale (VAS)
2
Description
Function and range of motion
Timepoint
Admission, one and 3 months later
Method of measurement
Constant Shoulder Score
Secondary outcomes
empty
Intervention groups
1
Description
Patient history, examination and shoulder X-ray (Ap & lat) will be produced. Before treatment, we use the VAS score for severity of pain and Constant Score for shoulder Range of motion and function in group A. We mark site of injection on patient's skin in sitting position. After sterilization of injection site, physiatrist inject 2 ml of Ketorolac (60 mg) with 1 ml of lidocaine in subacromial space (group A) by posterior approach.
Category
Treatment - Drugs
2
Description
Patient history, examination and shoulder X-ray (Ap & lat) will be produced. Before treatment, we use the VAS score for severity of pain and Constant Score for shoulder Range of motion and function in group B. We mark site of injection on patient's skin in sitting position. After sterilization of injection site, physiatrist inject 1 ml of methyl prednisolone with 1 ml of lidocaine in subacromial space (group B) by posterior approach.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Dr Sahar Mousavi
Street address
Sofe street
City
Isfahan
2
Recruitment center
Name of recruitment center
Ayat Allah Kashani hospital
Full name of responsible person
Dr Sahar Mousavi
Street address
Kashani street
City
Isfahan
3
Recruitment center
Name of recruitment center
Nour hospital
Full name of responsible person
Dr Sahar Mousavi
Street address
Ostandari street
City
Isfahan
4
Recruitment center
Name of recruitment center
Isa ebne Maryam hospital
Full name of responsible person
Dr Sahar Mousavi
Street address
Shams Abadi street
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Rasoul Rezayat
Street address
Isfahan University of Medical Sciences, Hezar jarib street.
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Sahar Mousavi
Position
MD
Other areas of specialty/work
Street address
Physical Medicine & Rehabilitation department, Alzahra hospital, Sofeh street.
City
Isfahan
Postal code
Phone
+98 913 300 2733
Fax
Email
s.mousavi.md@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Parisa Taheri
Position
Assistant Professor
Other areas of specialty/work
Street address
Assistant Professor of Physical Medicine & Rehabilitation
City
Department of Physical Medicine & Rehabilitation, Alzahra hospital,Sofeh street.
Postal code
Phone
+98 316685555
Fax
Email
Prs_taheri@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Sahar Mousavi
Position
MD
Other areas of specialty/work
Street address
Physical medicine & Rehabillitaion department, Alzahra hospital, Sofeh street.
City
Isfahan
Postal code
Phone
Fax
Email
s.mousavi.md@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)