CClinicalTrials.gg
CompletedNCT05317624PRPUpdated Apr 4, 2023

Ultrasound Guided Steroids Injection Versus PRP for Shoulder Pain Relief

An Early Phase 1 interventional study of Platelet rich plasma and Methylprednisolone in Shoulder Pain, sponsored by Alexandria University. Completed at 1 site in Egypt. Open to participants aged 20 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-04.

Sponsored by Alexandria University · Early Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Nov 2022, 3 years 11 months ago, and no results have been posted to the registry.
Phase
Early Phase 1
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
20 Years to 70 Years
Sex
All
01

Study summary

Comparison between effects of ultrasound guided platelet rich plasma injection versus steroids injection for pain relief in cases of partial rotator cuff tears

Read the detailed description

The effect of injection of platelet rich plasma will be compared with effects of steroids injection according to pain relief effects,, Side effects ,, healing ability ,, recurrence in both groups.

30 patient in each group will be included

02

Conditions studied

  • Shoulder Pain

Browse trials for

03

In context

Shoulder Pain

707 studies on the registry are indexed under Shoulder Pain; 152 are open to participants now.

This study's enrollment of 60 is close to the median of 60 across 561 interventional studies indexed under Shoulder Pain.

Browse Shoulder Pain studies →

Lead sponsor

Alexandria University is the lead sponsor of 569 studies on the registry; 125 are open to participants now.

Of its 12 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 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Patients with positive tests for rotator cuff pain
  2. Patients with positive radiological (US or MRI) findings of partial rotator cuff tear

Exclusion criteria

Exclusion Criteria:

  1. Patient refusal
  2. Age less than 20 years.
  3. Infection at injection site.
  4. Prior surgery on the shoulder joint area.
  5. Presence of other associated pathology in the shoulder joint
  6. Patients using antiplatelet drugs (aspirin).
  7. Contraindications to the use of platelet concentrate
  8. Contraindications to the steroids injection
05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Platelet rich plasma group

    participants will receive Ultrasound guided subacromial injection of 3 ml platelet rich plasma+0.5 ml of PRP activator (10% calcium gluconate)+ 1ml 0.5%bupivacaine.

    Combination Product: Platelet rich plasma

  • Experimental
    Methylprednisolone group

    participants will receive Ultrasound guided subacromial injection of 1 ml methylprednisolone+ 1ml 0.5%bupivacaine + 2.5 ml normal saline.

    Combination Product: Methylprednisolone

Interventions

  • Combination productPlatelet rich plasma

    platelet rich plasma will be obtained from the particepants own blood mixed with activator and bupivacaine

    Also known as: PRP group

  • Combination productMethylprednisolone

    1ml methyl prednisolone 40mg\\ml mixed with normal saline and bupivacaine

    Also known as: steroids group

06

What researchers measure

Primary outcomes

  1. Shoulder pain assesment

    The pain will be assessed using visual analogue scale( score range=0-10,less than 4,4-6 and more than 6 for mild, moderate and severe pain respectively)

    Time frame: 4 months

Secondary outcomes

  1. Assesment of rotator cuff tendon healing

    assesment healing process of tendon using ultrasound technique

    Time frame: 4 months

  2. Assesment the failure rate after shoulder joint injection

    failure of relief the symptoms after shoulder joint injection will be recorded

    Time frame: 4 months

  3. The reinjection rate recording

    the incidence of reinjection the shoulder joint due to inadequate pain relief will be recorded

    Time frame: 4 months

  4. Assesment the rate of tear recurrence after shoulder joint injection

    The rate of tear recurrence after 4 months of injection will be assessed using MRI or US

    Time frame: 4 months

  5. Simple shoulder assessment test

    Functional assessment of shoulder joint will be done using simple sholder assessment test 0= maximal disability 20% -40% = crippled 40% -60% = severe disability 60% -80% = moderate disability 100% = no disability

    Time frame: 4 months

Other outcomes

  1. Measurement plasma C-Reactive Protein level

    The plasma C- Reactive Protein level will be measured prior to injection and 4 months later on after the procedure

    Time frame: 4 months

  2. Measurement the fasting blood glucose level

    The fasting blood glucose level will be measure prior to and one week later after injection

    Time frame: one week

  3. Assesment the complications after shoulder joint injection

    Complications that might occur after shoulder joint injection such as infection, elevated blood sugar, allergy, nerve injury, nausea and vomiting will be recorded

    Time frame: 4 months

  4. Measurement the serum cortisol level

    Early morning(8 am serum cortisol level) will be measured before the injection and one week later after injection

    Time frame: one week

07

Study locations

1 site
  • Facility of medicine
    Alexandria, 21519, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 4, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05317624
Lead sponsor
Alexandria University
Responsible party
radwa saber (Radwa saber, Alexandria University) — Principal investigator
First posted
Apr 8, 2022
Start date
Aug 10, 2021
Primary completion
Nov 1, 2022
Completion
Feb 1, 2023
Last update
Apr 4, 2023

Study contacts

Dorreya Fikry
principal investigator · AlexandriaUniversity
Tarek Sarhan
study director · AlexandriaUniversity

Oversight

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

Not currently enrolling

This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion