Comparison of the effectiveness of ultrasound guided prolotherapy in supraspinatus tendon with ultrasound guided corticosteroid injection of subacromial subdeltoid bursa in rotator cuff related shoulder pain
Comparison of the effectiveness of ultrasound guided prolotherapy in supraspinatus tendon with ultrasound guided corticosteroid injection of subacromial subdeltoid bursa in rotator cuff related shoulder pain in patients referring to physical medicine and rehabilitation clinics in Shiraz during 2018-2019
Design
A randomized clinical trial including 2 comparing groups of steroid injection and dextrose50% injection with double blinded method
Settings and conduct
This research is a clinical trial study using the formula for comparing the mean in the community with alpha 5% and the power of 80% , the minimum sample size is 24 patients which is assessd with a drop of 5% in each group of 25 patients . we will include 30-65 year old patients with definitive clinical diagnosis of rotator cuff lesions (history and physical exam) referring to PM and R units under supervision of shiraz university of medical sciences in shiraz during 1397-1398 and the patients will be randomly allocated in two groups by block randomization assignment and double blind methods
Participants/Inclusion and exclusion criteria
30- 65 year old patients with long standing symptoms of at least 6 months or refractory to conservative managements for 3 months with rotator cuff lesion diagnosed in forms of tendinitis or partial tear by sonography or MRI are included and patients with RA, DM, osteomyelitis, active infectious disease,chronic infection in site of injection ,bleedinig tendency, pregnancy previous operation of site of injection and previous local injection in treatment site in 12 weeks ago are excluded
Intervention groups
2 groups for ultrasound guided injection are randomly allocated that in one group injection of steroid in bursa and in other group injection of dextrose50% in supraspinatus tendon are done
Main outcome variables
Pain and disability
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191129045542N1
Registration date:2020-05-08, 1399/02/19
Registration timing:retrospective
Last update:2020-05-08, 1399/02/19
Update count:0
Registration date
2020-05-08, 1399/02/19
Registrant information
Name
Leilasadat Mohamadijahromi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3648 6034
Email address
mohamadil.2668@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-11, 1398/09/20
Expected recruitment end date
2020-02-09, 1398/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of ultrasound guided prolotherapy in supraspinatus tendon with ultrasound guided corticosteroid injection of subacromial subdeltoid bursa in rotator cuff related shoulder pain
Public title
Comparison of the effectiveness of ultrasound guided prolotherapy in supraspinatus tendon with ultrasound guided corticosteroid injection of subacromial subdeltoid bursa in rotator cuff related shoulder pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients from 30-65 year old with long standing symptoms of at list 6 months or refractory to at list 3 months of conservative methods
rotator cuff lesions in the forms of tendinitis, partial tear which are diagnosed by sonography or MRI
Exclusion criteria:
Patients with RA, DIABETES, OSTEOMYELITIS,Active infectious disease, history of chronic infection in the treatment area,
positive history of previous operation of the involved shoulder
positive history of local injection at treatment area in 12 weeks ago
bleeding tendency
pregnancy
frozen shoulder
Age
From 30 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly allocated in to 2 groups by block randomization assignment and double blind methods. Based on sequences designed according to the block randomization method, for each patient the injectable material will be prepared in another room by non injectable person who is oriented. Then the syringe containig the injectable drug is brought to the injector in the sonography room
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients will be randomly allocated in to 2 groups by block randomization assignment and double blind methods. Based on sequences designed according to the block randomization method, for each patient the injectable material will be prepared in another room by non injectable person who is oriented. Then the syringe containig the injectable drug is brought to the injector in the sonography room
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committe of Shiraz University of Medical Sciences
Street address
Unit 4 in Shahab building,Koohbor4 line,Namazi street,Satarkhan street,Shiraz,Iran
City
Shiraz
Province
Fars
Postal code
7184747538
Approval date
2018-08-15, 1397/05/24
Ethics committee reference number
IR.SUMS.MED.REC.1397.186
Health conditions studied
1
Description of health condition studied
rotator cuff dysfunction
ICD-10 code
M75.100
ICD-10 code description
Unspecified rotator cuff tear or rupture of unspecified shoulder, not specified as traumatic
Primary outcomes
1
Description
pain and disability of shoulder
Timepoint
before, 3 and 12 weeks after injection
Method of measurement
visual analogue scale and shoulder pain and disability scale
Secondary outcomes
1
Description
scores of function and quality of life
Timepoint
before, 3 and 12 weeks after injection
Method of measurement
shoulder pain and disability index
Intervention groups
1
Description
Intervention group1: patients with chronic supraspinatus tendinopathy who recieved prolotherapy in multiple points of injured tendon
Category
Treatment - Other
2
Description
Intervention group2: patients with chronic supraspinatus tendinopathy who recieved corticosteroid injection in subacromial bursa
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Physical medicine and rehabilitation unit in Imam Reza clinic
Full name of responsible person
Aref Nasiri
Street address
Namazi square
City
Shiraz
Province
Fars
Postal code
-
Phone
+98 71 3212 7002
Email
nasiri.aref@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Aref Nasiri
Street address
Zand avenue
City
Shiraz
Province
Fars
Postal code
-
Phone
+98 71 3212 7002
Email
nasiri.aref@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Aref Nasiri
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Zand avenue, Faghihi hospital
City
Shiraz
Province
Fars
Postal code
-
Phone
0098712319040
Email
nasiri.aref@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Aref Nasiri
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Zand avenue, Faghihi hospital
City
Shiraz
Province
Fars
Postal code
-
Phone
00982319040
Email
nasiri.aref@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Aref Nasiri
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Zand ave, Faghihi hospital
City
Shiraz
Province
Fars
Postal code
-
Phone
0098712319040
Email
nasiri.aref@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
-
When the data will become available and for how long
-
To whom data/document is available
-
Under which criteria data/document could be used
--
From where data/document is obtainable
-
What processes are involved for a request to access data/document