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Completed

NCT Number: NCT03942679

Platelet Rich Plasma and Supraspinatus Tear

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

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Key information

Conditions

Supraspinatus Tear

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Reham Magdy Shaat

Al Mansurah, Dakahlia Provence, 050, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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),

Treatment and study plan

PRP

Other

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.

Physiotherapy

Other

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.

Primary outcomes

  1. change of pain from base line

    Time frame: 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

  2. change of range of motion from base line

    Time frame: 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 outcomes

  1. change of shoulder index score from base line

    Time frame: 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.

  2. change of ultrasound pathology from base line

    Time frame: immediately before injection,,12 weeks after injection

    •US documented pathology will be assessed at diagnosis and at 12 weeks.

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 8, 2019
Registry last updated
Apr 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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