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CompletedNCT03942679Updated Apr 16, 2020

Platelet Rich Plasma and Supraspinatus Tear

An interventional study of PRP and physiotherapy in Supraspinatus Tear, sponsored by Mansoura University. Completed at 1 site in Egypt. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2020-04-16.

Sponsored by Mansoura University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
20 Years to 60 Years
Sex
All
01

Study 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

Read the 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

02

Conditions studied

  • Supraspinatus Tear
03

In context

Lead sponsor

Mansoura University is the lead sponsor of 1,115 studies on the registry; 184 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

chronic partial supraspinatus tears will be included in the study

Exclusion criteria

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),

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • 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

  • 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

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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: immediately before injection,6 weeks after injection,12 weeks after injection

  2. 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

    Time frame: immediately before injection,6 weeks after injection,12 weeks after injection

Secondary outcomes

  1. change of shoulder index score from base line

    •Disability and health related quality of life will be measured using DASH shoulder rating scale.

    Time frame: immediately before injection,6 weeks after injection,12 weeks after injection

  2. change of ultrasound pathology from base line

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

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

07

Study locations

1 site
  • Reham Magdy Shaat
    Al Mansurah, Dakahlia Provence 050, Egypt
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jun 2019 to primary completion in Apr 2020, 10 months.

How these figures are worked out, and which studies are left out of them.

Registered
May 7, 2019
First posted
May 8, 2019
StartActual
Jun 1, 2019
Primary completionActual
Apr 1, 2020
CompletionActual
Apr 10, 2020
Last update
Apr 16, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 16, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03942679
Responsible party
Sponsor
First posted
May 8, 2019
Start date
Jun 1, 2019
Primary completion
Apr 1, 2020
Completion
Apr 10, 2020
Last update
Apr 16, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.

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