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The comparison of effectiveness of high leukocyte and low leukocyte PRP in tendinopathy and partial tear of rotator cuff

The comparison of the effectiveness of high leukocyte PRP, low leukocyte PRP & placebo in treatment of the patients having rotator cuff tendinopathy or partial tear

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20100718004409N12
Enrollment
75
Registered
2019-09-28
Start date
2019-01-21
Completion date
Unknown
Last updated
2019-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Condition 1: rotator cuff tendinopathy, partial tear of rotator cuff. Condition 2: Shoulder impingement. Rotator cuff tear or rupture, not specified as traumatic Impingement syndrome of unspecified shoulder

Interventions

Intervention 1: Intervention group 1: Platelet rich plasma with high leukocyte 20 cc blood will be centrifuged in two 10- minute steps by Rooyagen kit then the 2 cc of the plas

Sponsors

Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to No maximum

Inclusion criteria

Inclusion criteria: Shoulder pain lasted more than 6 weeks At least 3 positive specific shoulder tests MRI findings implying tendinopathy or partial tear of rotator cuff

Exclusion criteria

Exclusion criteria: Shoulder pain that lasted less than six weeks The presence of sensory or motor disturbances caused by the cervical radiculer pain Evidence from other pathologies that can lead to shoulder pain. For example, the presence of calcified tendonitis or adhesive capsulitis and ... History of shoulder surgery in the last 6 months The presence of inflammatory rhomatologic diseases such as rheumatoid arthritis, fibromyalgia, poly mialia rheumatica and ... Complete rupture of rotator cuff tendons based on MRI findings The presence of ligamentous laxity or shoulder instability based on physical examination History of corticosteroid, analgesic or hyaluronic acid injection in the shoulder joint over the past 3 months History of exercise therapy and physiotherapy modalities over the past 6 weeks The history of treatment with PRP in the last 6 months Use of other therapies during the intervention period Patients request for discontinuing the treatment Contraindications for performing MRI or PRP in patients Any non-rheumatologic inflammatory disease and severe acute infection in patients Thrombocytopenia in patients

Design outcomes

Primary

MeasureTime frame
Pain amount. Timepoint: Before intervention, 1 ,3 ,6 months after intervention. Method of measurement: Visual Analog Scale.;Function of the patients. Timepoint: Before intervention, 1 ,3 ,6 months after intervention. Method of measurement: WORC & DASH questionnaires.

Secondary

MeasureTime frame
Shoulder range of motion. Timepoint: Before the intervention, 1,3,6 months after intervention. Method of measurement: Goniometry.;Rotator cuff strength. Timepoint: Before the intervention, 1,3,6 months after intervention. Method of measurement: Muscle Manual Test.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactParisa Nejati

Iran University of Medical Sciences

parisanejati2@gmail.com+98 21 6651 5001

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026