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Platelet Rich Plasma and Supraspinatus Tear

Efficacy of Platelet Rich Plasma Injection in Comparison to Physical Therapy for Treatment of Chronic Partial Supraspinatus Tears

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03942679
Enrollment
40
Registered
2019-05-08
Start date
2019-06-01
Completion date
2020-04-10
Last updated
2020-04-16

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

Conditions

Supraspinatus Tear

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

Interventions

OTHERPRP

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.

OTHERphysiotherapy

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.

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No

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),

Design outcomes

Primary

MeasureTime frameDescription
change of pain from base lineimmediately before injection,6 weeks after injection,12 weeks after injectionThe VAS-pain score is composed of a continuous horizontal line. This line is 100 mm in length. To measure the intensity of pain, the score is anchored by (0 score = no pain) at one end and (100 score = worst imaginable pain) on the other end. The patient places a mark to the VAS line at the point which represents the intensity of his pain
change of range of motion from base lineimmediately before injection,6 weeks after injection,12 weeks after injectionIII. Examination of passive and active range of motion using goniometer based on the description of norkin and white as following * Abduction ;170 * Adduction :50 * Flexion :165 * Extension:60 * Internal rotation at 90 abduction :70 * External rotation at 90 abduction :100

Secondary

MeasureTime frameDescription
change of shoulder index score from base lineimmediately before injection,6 weeks after injection,12 weeks after injection•Disability and health related quality of life will be measured using DASH shoulder rating scale.
change of ultrasound pathology from base lineimmediately before injection,,12 weeks after injection•US documented pathology will be assessed at diagnosis and at 12 weeks.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026