Protocol summary
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Study aim
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Comparison of clinical findings in patients Shoulder tendinopathy with Platelet Rich Plasma and corticosteroid injecting
Comparison of the effect of PRP and corticosteroid on pain relief in patients with shoulder tendonopathy
Comparison of the effect of PRP and corticosteroid on the range of motion of patients with shoulder tendonopathies
Comparison of PRP effect on and corticosteroid supraspinatus tendon thickness in patients with shoulder tendonopathies
Comparison of WORC and DASH questionnaire score changes after PRP and corticosteroid injection in patients with shoulder tendonopathy
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Design
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Randomized clinical trial, single blind, parallel group, 56 patients
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Settings and conduct
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The study (injection and exercise therapy) was performed in the sports medicine department of Rasoul Hospital.
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Participants/Inclusion and exclusion criteria
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Shoulder pain that lasts more than three months (162)
Age over 40 years
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Intervention groups
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PRP injection group,
The other group, corticosteroid injections a
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Main outcome variables
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Pain, Range of Motion, Thickness of tendon
General information
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Reason for update
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Increase the follow-up time of patients after shoulder injection
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Acronym
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PRP
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IRCT registration information
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IRCT registration number:
IRCT201302174251N9
Registration date:
2013-05-03, 1392/02/13
Registration timing:
registered_while_recruiting
Last update:
2020-05-16, 1399/02/27
Update count:
1
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Registration date
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2013-05-03, 1392/02/13
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Tehran University of Medical Sciences
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Expected recruitment start date
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2013-04-21, 1392/02/01
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Expected recruitment end date
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2015-04-21, 1394/02/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparative study of corticosteroid injections and platelet rich plasma in the treatment of patients with shoulder tendinopathy compare sonographic findings
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Public title
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Comparing the effect of corticosteroid injections and platelet rich plasma on the treatment of shoulder tendinopathy
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Shoulder pain that lasts for more than 3 months
limited shoulder range of motion
Absence of radicular pain
Inflammatory disorders such as rheumatoid arthritis
Fibromyalgia
lack of complete rotator cuff tear
The ligament laxity
Non-corticosteroid injections in the past three months
Exclusion criteria:
Unwillingness of the patient to continue treatment
shoulder joint surgery
The presence of other disorders that limit joint motion such as frozen shoulder
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Age
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From 40 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
56
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Patients are randomly divided into two groups based on random number table after confirming the diagnosis with MRI and referring to the sports medicine department.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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The platelet rich plasma group is injected one time. In this group, 35 ml of venous blood was taken and by the Selex centrifuge under the RCF protocol, the blood sample is separated from rich plasma platelet by 1700 and 3200 rpm. Plasma rich platelets are separated after adding calcium gluconate 10% cc platelet concentrate obtained. The injection is performed by a sports medicine specialist in the form of intraarticular with an angle of 30-45 degrees from the posterolateral.
And if there is a partial rupture in tendon, 3 cc PRP injection is performed under ultrasound guidance at the tendon rupture site.
One week after the injection, the patient is visited, examined, given the necessary advice and also exercise prescription. Exercise is divided to scapula rehabilitation and shoulder muscles training.
After one and three months, repeated examinations, including pain, function, Completion of WORC, DASH questionnaire and ultrasound changes was achieved , and a comparison between the patient's clinical and Para clinical symptoms within these periods was performed.
The injection for corticosteroid group, however, is applied Methylprednisolone 40 mg once. For patients, one cc of Depomedrol and one cc of 2% lidocaine solution are injected into the intra articular joint in the same PRP manner. In this group, due to the blindness of the study, blood sampling of the patient is performed before corticosteroid injection.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2012-07-20, 1391/04/30
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Ethics committee reference number
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19910-91-4-30
Health conditions studied
1
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Description of health condition studied
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Shoulder Tendinopathy
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ICD-10 code
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M75.1
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ICD-10 code description
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rotator cuff syndrome rotator cuff or supraspinatous tear or rupture (complete ) ( incomplete ) not specified as traumatic
Primary outcomes
1
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Description
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Pain
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Timepoint
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every 2 weeks up to 8 weeks
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Method of measurement
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VAS scale
2
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Description
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range of motion
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Timepoint
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every 2 weeks up to 3 months
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Method of measurement
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Goniameter
3
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Description
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Sonographic finding
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Timepoint
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at base line and 3 months later
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Method of measurement
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Sonographic prob
Intervention groups
1
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Description
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The platelet rich plasma group is injected twice within a month. In this group, 20 ml of venous blood was taken by centrifuges Selex protocol RCF, blood samples from the men with the 1800 and 2000 cycles and women with 1600 and 2000 cycle. Plasma rich platelets are separated after adding calcium gluconate 10% cc platelet concentrate obtained. Under ultrasound Guide, in collaboration with a radiologist and a sports medicine specialist in the area of sub-45 degree lateral Acromion is injected (based on Sonographic Guide). Assessment of clinical sing such as pain (based on VAS measurement), shoulder range of motion and its function is occurred. Moreover, musculoskeletal sonography is applied by two clinician experts. These (findings are) recorded and compared
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Category
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Treatment - Drugs
2
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Description
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The injection for corticosteroid group, however, is applied MethylPrednisolone 40 mg once or twice within a month based on the Rheumatologist decision.
At the baseline, after four weeks and also eight weeks after intervention, all the studies including pain, range of motion, function, and Sonographic findings changes are evaluated and compared with the data which is recorded before intervention
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Iran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available
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Title and more details about the data/document
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After deidentifing participants, sharing data related to pain, ROM, function and thickness of tendon will be happened
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When the data will become available and for how long
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starting 6 months after publication
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To whom data/document is available
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Researchers and people working in Academic institution
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Under which criteria data/document could be used
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To applied in research or manuscript
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From where data/document is obtainable
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Personal email, Mobile phone , research gate
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What processes are involved for a request to access data/document
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3 months after applying, the document will send through email
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Comments
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