Platelet Rich Plasma and Supraspinatus Tear

NCT03942679 | Completed

• 1 other identifier: MS/17.08.79
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Supraspinatus Tear

Outcome Measures

Primary Outcomes (2)

• change of pain from base line

  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

  immediately before injection,6 weeks after injection,12 weeks after injection

• change of range of motion from base line

  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

  immediately before injection,6 weeks after injection,12 weeks after injection

Secondary Outcomes (2)

• change of shoulder index score from base line

  immediately before injection,6 weeks after injection,12 weeks after injection

• change of ultrasound pathology from base line

  immediately before injection,,12 weeks after injection

Study Arms (2)

PRPinjection group

OTHER

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

physiotherapy group

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

Other: physiotherapy

Interventions

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.

PRPinjection group

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.

physiotherapy group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• chronic partial supraspinatus tears will be included in the study

You may not qualify if:

• 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),

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Reham Magdy Shaat

Al Mansurah, Dakahlia Provence, 050, Egypt

Location

MeSH Terms

Interventions

Physical Therapy Modalities

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2019
• First Posted: May 8, 2019
• Study Start: June 1, 2019
• Primary Completion: April 1, 2020
• Study Completion: April 10, 2020
• Last Updated: April 16, 2020

Record last verified: 2019-05

Locations

EG (1)