Shoulder PainEarly Phase 1PRPNCT05317624
Ultrasound Guided Steroids Injection Versus PRP for Shoulder Pain Relief
A Early Phase 1 study testing Platelet rich plasma and Methylprednisolone in people with Shoulder Pain, run by Alexandria University at 1 site in Egypt.
Trial 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 more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- Platelet rich plasma and Methylprednisolone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Aug 2021to 1 Feb 2023
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with positive tests for rotator cuff pain
- Patients with positive radiological (US or MRI) findings of partial rotator cuff tear
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Ultrasound Guided Platelet Rich Plasma Injection Versus Steroids Injection for Pain Relief in Cases of Partial Rotator Cuff Tears
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
- Conditions
- Shoulder Pain
- Being tested
- Platelet rich plasma, Methylprednisolone
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet rich plasmaCombination product
Also called PRP group
platelet rich plasma will be obtained from the particepants own blood mixed with activator and bupivacaine
MethylprednisoloneCombination product
Also called steroids group
1ml methyl prednisolone 40mg\ml mixed with normal saline and bupivacaine
| Study group | Role | What they receive |
|---|---|---|
| Platelet rich plasma group | Experimental | 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. Receives: Combination Product: Platelet rich plasma |
| Methylprednisolone group | Experimental | participants will receive Ultrasound guided subacromial injection of 1 ml methylprednisolone+ 1ml 0.5%bupivacaine + 2.5 ml normal saline. Receives: Combination Product: Methylprednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 4 months
Secondary outcomes (5)
Assesment of rotator cuff tendon healing
assesment healing process of tendon using ultrasound technique
Measured: 4 months
Assesment the failure rate after shoulder joint injection
failure of relief the symptoms after shoulder joint injection will be recorded
Measured: 4 months
The reinjection rate recording
the incidence of reinjection the shoulder joint due to inadequate pain relief will be recorded
Measured: 4 months
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
Measured: 4 months
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
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start10 Aug 2021
- Primary completion1 Nov 2022
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 groups will be included
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, radwa saber, Alexandria University
- Investigators
- Dorreya Fikry, Principal investigator, AlexandriaUniversityTarek Sarhan, Study director, AlexandriaUniversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05317624
- Sponsor's protocol ID
- 0201491
- Acronym
- PRP
- Status last verified
- Sep 2022
- First submitted
- 19 Jul 2021
- Last updated
- 4 Apr 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Ultrasound Guided Platelet Rich Plasma Injection Versus Steroids Injection for Pain Relief in Cases of Partial Rotator Cuff Tears
- ClinicalTrials.gov ID
- NCT05317624
- Acronym / sponsor ID
- PRP / 0201491
- Conditions
- Shoulder Pain
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 10 Aug 2021 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 8 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparison between effects of ultrasound guided platelet rich plasma injection versus steroids injection for pain relief in cases of partial rotator cuff tears
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 2 groups will be included
| Arm | Type | Receives |
|---|---|---|
| Platelet rich plasma group | Experimental | Combination Product: Platelet rich plasmaparticipants 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. |
| Methylprednisolone group | Experimental | Combination Product: Methylprednisoloneparticipants will receive Ultrasound guided subacromial injection of 1 ml methylprednisolone+ 1ml 0.5%bupivacaine + 2.5 ml normal saline. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with positive tests for rotator cuff pain
- Patients with positive radiological (US or MRI) findings of partial rotator cuff tear
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Platelet rich plasmaAlso: PRP groupplatelet rich plasma will be obtained from the particepants own blood mixed with activator and bupivacaine | Combination product | Platelet rich plasma group |
| MethylprednisoloneAlso: steroids group1ml methyl prednisolone 40mg\ml mixed with normal saline and bupivacaine | Combination product | Methylprednisolone group |
Primary outcome
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)
5 secondary outcomes
Assesment of rotator cuff tendon healing
Time frame: 4 months
Assesment the failure rate after shoulder joint injection
Time frame: 4 months
The reinjection rate recording
Time frame: 4 months
Assesment the rate of tear recurrence after shoulder joint injection
Time frame: 4 months
Simple shoulder assessment test
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2023.
Related trials for Shoulder Pain
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Recruiting
Hybrid mHealth and Telerehabilitation vs Conventional Physiotherapy for Subacromial Pain Syndrome
Subacromial Pain Syndrome
Not yet recruiting
Magnesium Sulphate as an Adjuvant in Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block for Ambulatory Shoulder Arthroscopy
Postoperative Pain, Shoulder Arthroscopy
Active, not recruiting
Effects of Injection Combined With Spencer Technique on Painful Frozen Shoulder
Frozen Shoulder
Not yet recruiting
Laser Therapy Versus Transcutaneous Electical Nerve Stimulation at Hemiplegic Shoulder Pain
Hemiplegic Shoulder Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dorreya Fikry principal investigator
AlexandriaUniversity
Tarek Sarhan study director
AlexandriaUniversity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Platelet rich plasma and Methylprednisolone in people with Shoulder Pain, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shoulder pain assesment (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2023.