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Completed

NCT Number: NCT05317624

Ultrasound Guided Steroids Injection Versus PRP for Shoulder Pain Relief

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

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Key information

Conditions

Shoulder Pain Arthralgia Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Facility of medicine

Alexandria, 21519, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

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

Exclusion criteria

  • Patient refusal
  • Age less than 20 years.
  • Infection at injection site.
  • Prior surgery on the shoulder joint area.
  • Presence of other associated pathology in the shoulder joint
  • Patients using antiplatelet drugs (aspirin).
  • Contraindications to the use of platelet concentrate
  • Contraindications to the steroids injection

Treatment and study plan

Platelet Rich Plasma

Combination Product

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

Other names: PRP group

Methylprednisolone

Combination Product

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

Other names: steroids group

Primary outcomes

  1. Shoulder pain assesment

    Time frame: 4 months

    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)

Secondary outcomes

  1. Assesment of rotator cuff tendon healing

    Time frame: 4 months

    assesment healing process of tendon using ultrasound technique

  2. Assesment the failure rate after shoulder joint injection

    Time frame: 4 months

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

  3. The reinjection rate recording

    Time frame: 4 months

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

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

    Time frame: 4 months

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

  5. Simple shoulder assessment test

    Time frame: 4 months

    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

Other outcomes

  1. Measurement plasma C-Reactive Protein level

    Time frame: 4 months

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

  2. Measurement the fasting blood glucose level

    Time frame: one week

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

  3. Assesment the complications after shoulder joint injection

    Time frame: 4 months

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

  4. Measurement the serum cortisol level

    Time frame: one week

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

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

Evaluation of Ultrasound Guided Platelet Rich Plasma Injection Versus Steroids Injection for Pain Relief in Cases of Partial Rotator Cuff Tears

Acronym: PRP

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Apr 8, 2022
Registry last updated
Apr 4, 2023

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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