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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

Platelet Rich Plasma and Supraspinatus Tear

Clinicaltrials.gov identifier NCT03942679

Recruitment Status Completed

First Posted May 8, 2019

Last update posted April 16, 2020

Study Description

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

  • Condition or Disease:Supraspinatus Tear
  • Intervention/Treatment: Other: PRP
    Other: physiotherapy
  • Phase: N/A
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

Study Design
  • Study Type: Interventional
  • Actual Enrollment: 40 participants
  • Allocation: Randomized
  • Intervention Model: Sequential Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: Efficacy of Platelet Rich Plasma Injection in Comparison to Physical Therapy for Treatment of Chronic Partial Supraspinatus Tears
  • Actual Study Start Date: June 2019
  • Actual Primary Completion Date: April 2020
  • Actual Study Completion Date: April 2020
Arms and interventions
Arm Intervention/treatment
Other: PRPinjection group
Patients in this group will receive three ultrasound guided PRP injections in the supraspinatus tendon with one week interval (Ilhanli et al., 201
Other: PRP
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.
Other: physiotherapy 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
Other: 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). After the physical therapy, the exercise program will be continued as homework during the follow-up period.
Outcome Measures
  • Primary Outcome Measures: 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 Outcome Measures: 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.
Eligibility Criteria
  • Ages Eligible for Study: 20 to 60 Years (Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
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),

Contacts and Locations
Contacts
Locations

Egypt, Dakahlia Provence
Reham Magdy Shaat
Mansoura

Sponsors and Collaborators

Mansoura University

More Information
  • Responsible Party: Mansoura University
  • ClinicalTrials.gov Identifier: NCT03942679 History of Changes
  • Other Study ID Numbers: MS/17.08.79
  • First Posted: May 8, 2019 Key Record Dates
  • Last Update Posted: April 16, 2020
  • Last Verified: May 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: Undecided
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No