Platelet Rich Plasma and Supraspinatus Tear

Not Applicable

Completed

• Conditions: Supraspinatus Tear
• Interventions: Other: physiotherapy; Other: PRP

• Registration Number: NCT03942679
• Lead Sponsor: Mansoura University

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2019-05
• Study First Submitted: 2019-05-07
• Study First Submitted QC: 2019-05-07
• Study First Posted: 2019-05-08
• Study Start: 2019-06-01
• Primary Completion: 2020-04-01
• Study Completion: 2020-04-10
• Last Update Submitted: 2020-04-14
• Last Update Posted: 2020-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

chronic partial supraspinatus tears will be included in the study

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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),

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
physiotherapy group	physiotherapy	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
PRPinjection group	PRP	Patients in this group will receive three ultrasound guided PRP injections in the supraspinatus tendon with one week interval (Ilhanli et al., 201

Primary Outcome Measures

Name	Time	Method
change of pain from base line	immediately before injection,6 weeks after injection,12 weeks after injection	The 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 line	immediately before injection,6 weeks after injection,12 weeks after injection	III. 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 Outcome Measures

Name	Time	Method
change of shoulder index score from base line	immediately 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 line	immediately before injection,,12 weeks after injection	•US documented pathology will be assessed at diagnosis and at 12 weeks.

Trial Locations

Locations (1)

Reham Magdy Shaat; 🇪🇬 Mansoura, Dakahlia Provence, Egypt