Comparing the effect of exercise therapy and Platelet Rich Plasma injection in pain and symptoms in people over 40 that suffer from subacromial impingement syndrome
The aim of this study is comparing exercise therapy and PRP injection in subacromial impingement syndrome . It is a randomized controlled trial . 42 patients over 40 with complaint of shoulder pain at least 3 months , have positive finding in physical exam forshoulder impingement syndrome , whose diagnose has been proved with shoulder MRI are included in the study . 42 participants
are randomly assigned to each of the 2 treatment groups : group 1 exercise therapy group 2 PRP injection . Subjects in the exercise group are receive an individualized exercise program that is developed and supervised by a physician once a week . The patients are asked to exercise every day at home for 3 months according to the booklet . In second group , approximately 10 cc of venous blood is drawn from the patient and is prepared according to the Regenlab manufacturer`s guidelines, then the 2 cc accessed PRP is injected under ultrasound guidance using a lateral approach . Before and after 1, 3, 6 months of treatment all patients are evaluated to check the range of motion of shoulder joint , strength of rotator cuff muscles . patients complete DASH and WORC questionnaire to evaluate the pain and function . If the WORC and DASH scores remain unchanged in the PRP group until the last 1 month , another PRP injection is repeated . MRI is performed in all cases at the sixth month .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201308064409N3
Registration date:2013-08-30, 1392/06/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-08-30, 1392/06/08
Registrant information
Name
Parisa Nejati
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4480 0361
Email address
parisanejati@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Science
Expected recruitment start date
2013-08-23, 1392/06/01
Expected recruitment end date
2014-02-20, 1392/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of exercise therapy and Platelet Rich Plasma injection in pain and symptoms in people over 40 that suffer from subacromial impingement syndrome
Public title
Exercise therapy and Platelet Rich Plasma injection in shoulder pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : A shoulder pain that has been lasted for more than three months , age over 40
exclusion criteria : Radicular pain , Other causes of shoulder pain such as the frozen shoulder, the history of shoulder surgery during 6 months ago , The inflammation disorders such as ; Rheumatoid arthritis , Fibromyalgia , Polymyalgia rheumatica . Full thickness tear of rotator cuff tendon , Ligamentous laxity or shoulder dislocation (a positive sulcus test or apprehensive test )
Age
From 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran Uneversity of Medical Sciences
Street address
Iran University of Medical Science , Hemat highway
City
Tehran
Postal code
1417614411
Approval date
2013-04-19, 1392/01/30
Ethics committee reference number
21391-89429
Health conditions studied
1
Description of health condition studied
subacromial impingement syndrome
ICD-10 code
M75.1 ,M75
ICD-10 code description
Rotator cuff syndrome, Impingement syndrome of shoulder , Bursitis of shoulder
Primary outcomes
1
Description
Range Of Motion of shoulder joint
Timepoint
Before intervention and 1,3,6 months after intervention
Method of measurement
goniometer
2
Description
strength of shoulder muscles
Timepoint
Before intervention and 1,3,6 months after intervention
Method of measurement
Muscle manual test (MMT)
3
Description
WORC - score
Timepoint
Before intervention and 1,3,6 months after intervention
Method of measurement
WORC Questionnaire
4
Description
DASH- score
Timepoint
Before intervention and 1,3,6 months after intervention
Method of measurement
DASH Questionnaire
5
Description
Rotator cuff tendon pathology ( supra spinatus ,infra spinatus,teres minor, sub scapularis)
Timepoint
Before intervention and 6 months after intervention
Method of measurement
MRI
Secondary outcomes
1
Description
Acromiohumeral distance
Timepoint
Before intervention , 6 months after intervention
Method of measurement
MRI
2
Description
Sub acromion sub deltoid bursea pathology
Timepoint
Before intervention , 6 months after intervention
Method of measurement
MRI
3
Description
Glenohumeral fluid collections
Timepoint
Before intervention , 6 months after intervention
Method of measurement
MRI
4
Description
Acromion shape
Timepoint
Before intervention , 6 months after intervention
Method of measurement
MRI
Intervention groups
1
Description
In intervention group : 2 cc PRP is prepared according to the (Regenlab) manufacturar`s guidelines then is injected under ultrasound guidance using a lateral approach.If the WORC and DASH scores remain unchanged until the last 1 month another PRP injection is repeated
Category
Treatment - Drugs
2
Description
Control group : The patients are received an individualized exercise program that is developed and supervised by a physician once a week. The patients are asked to exercise everyday for 3 months at home according to the booklet
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul akram hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Science
Full name of responsible person
Dr.abbas motevalian
Street address
Vice-chanellor for research ,Headquarter for Iran University of Medical Sciences , Hemat highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Science
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
Iran University of Medical Sciences
Full name of responsible person
Parisa Nejati
Position
Assistant professor
Other areas of specialty/work
Street address
Sport medicine clinic , Rasool akram hospital , Niayesh street , Sattar khan street
City
Tehran
Postal code
Phone
+98 21 6435 2446
Fax
Email
parisanejati@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Parisa Nejati
Position
Assistant professor
Other areas of specialty/work
Street address
Sport medicine clinic , Rasool akram hospital , niayaesh street , sattar khan street
City
Tehran
Postal code
Phone
+98 21 6435 2446
Fax
Email
parisanejati@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Parisa Nejati
Position
Assistant professor
Other areas of specialty/work
Street address
Sport medicine clinic , Rasool akram hospital , niayaesh street , sattar khan street
City
Tehran
Postal code
Phone
+98 21 6435 2446
Fax
Email
parisanejati@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)