Clinical trial NCT03942679: Platelet Rich Plasma and Supraspinatus Tear
Official title: Efficacy of Platelet Rich Plasma Injection in Comparison to Physical Therapy for Treatment of Chronic Partial Supraspinatus Tears
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Supraspinatus Tear
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2019-05-08
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: Rheumatology and Rehabilitation Department, Mansoura University Hospital. Forty patients with chronic partial supraspinatus tears will be included in the study. The diagnosis of the supraspinatus tear will be made by ultrasound examination

Detailed description: At inclusion in the study, demographic data (age, gender, duration of complaints, and body mass index) will be recorded.

Randomization

Patients will be randomized into two matched groups:

A) PRP-Injection Group - Patients in this group will receive three ultrasound guided PRP injections in the supraspinatus tendon with one week interval (Ilhanli et al., 2015). After the injection, patients will be instructed to limit the use of shoulder for at least 24 hours and to use cold therapy for pain. After the third injection, ROM, and stretching exercises will be allowed and one month after the end of injections, patients will be recommended to begin the strengthening program as tolerated. Exercise is performed with 10 repeats five sessions per week.

B) Physical Therapy Group - Patients in this group will be treated with hot pack for 15 minutes, ultrasound in continuous mode (1.5 watt/cm2 for five minutes), trans-cutaneous electrical nerve stimulation in brief-intense mode for 15 minutes, range of motion (ROM), followed by stretching and strengthening exercises with 10 repeats 15 sessions (five sessions per week for three weeks). After the physical therapy, the exercise program will be continued as homework during the follow-up period.

Patients in t

Eligibility criteria: Inclusion Criteria:

chronic partial supraspinatus tears will be included in the study

Exclusion Criteria:

age \> 80 years, pregnancy, full thickness supraspinatus tears, other rotator cuff lesions with/without supraspinatus tears, systemic disorders such as diabetes rheumatoid arthritis, hematological diseases (co-agulopathy),

Primary outcomes:
measure: change of pain from base line
timeFrame: immediately before injection,6 weeks after injection,12 weeks after injection
measure: change of range of motion from base line
timeFrame: immediately before injection,6 weeks after injection,12 weeks after injection
Secondary outcomes:
measure: change of shoulder index score from base line
timeFrame: immediately before injection,6 weeks after injection,12 weeks after injection
measure: change of ultrasound pathology from base line
timeFrame: immediately before injection,,12 weeks after injection
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Reham Magdy Shaat
state: Dakahlia Provence
Study officials:
References: