Shoulder OsteoarthritisNCT05043493
Effect of PRP as Therapy for Shoulder Osteoarthritis
A study testing Injection in the intraarticular space of glenohumeral joint in people with Shoulder Osteoarthritis, run by Ain Shams University at 1 site in Egypt.
Trial summary
Patients with shoulder osteoarthritis are suffering from pain and disabilities which lead to difficulties in life. The presence of platelet-rich plasma as regenerative therapy which helps in healing of damaged tissues like ligaments and joint might be of great benefit in managing such conditions. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Shoulder Osteoarthritis
- What is being tested?
- Injection in the intraarticular space of glenohumeral joint
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 91 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2021to 3 Aug 2021
- Phase
- Interventional
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient's age: From 21 years.
- Acute symptoms on a background of at least a 3-month history of chronic pain or swelling of the shoulder joint with radiological confirmed (X-ray or MRI)
- Mild or moderate osteoarthritis of the shoulder joint according to The Samilson-Prieto classification.
- Numerical Rating Scale for pain scores greater than five on a 10 scale
Who cannot join
- Under 21 years of age
- Severe osteoarthritis according to The Samilson-Prieto classification. (Figure 1)
- Neuropsychiatric disorders.
- Immunocompromised patients.
- Active infection or malignancy at the joint.
- Pregnancy and breastfeeding.
- Patients may have thrombocytopenia, bleeding disorders, or on anticoagulant therapy.
- Shoulder surgery within 3 months or inflammatory arthritis; previous infection of the shoulder joint.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Platelet Rich Plasma Therapy for Shoulder Osteoarthritis :Double Blinded Randomized Controlled Study
Patients with shoulder osteoarthritis are suffering from pain and disabilities which lead to difficulties in life. The presence of platelet-rich plasma as regenerative therapy which helps in healing of damaged tissues like ligaments and joint might be of great benefit in managing such conditions.
Read the detailed description
Primary and secondary osteoarthritis of the shoulder occurs due to destruction of the articular surface of the humeral head and glenoid , Patient mainly presented with pain and decreases in the range of motion .
Treatment of shoulder osteoarthritis is often controversial and is typically based on the patient's age, the severity of symptoms, and level of activity, radiographic findings, and medical comorbidities.
The new era of management include regenerative therapy ,Platelet-rich plasma (PRP) is one of the regenerative therapy that prove its effect as injections of a concentration of a patient's own platelets to accelerate the healing of injured tendons, ligaments, muscles and joints.
- Conditions
- Shoulder Osteoarthritis
- Being tested
- Injection in the intraarticular space of glenohumeral joint
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injection in the intraarticular space of glenohumeral jointProcedure or surgery
U/S guided injection of platelet rich plasma (PRP) or normal saline (NS)
| Study group | Role | What they receive |
|---|---|---|
| Injection (study) group | Active comparator | This group will receive platelet rich plasma (PRP) injection Receives: Procedure: Injection in the intraarticular space of glenohumeral joint |
| Control group | Placebo comparator | This group will receive normal saline (NS) injection Receives: Procedure: Injection in the intraarticular space of glenohumeral joint |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in patient's pain score
By using NUMERICAL PAIN SCALE patient will mention them pain score on scale from 1 to 10, where the pain score to be included in the study is 5 and more , we will measure pain score for each patient after 2 weeks from injection ,where decrease of the number from the initial recorded number before injection means improvement.
Measured: 2 weeks after each injection
Secondary outcomes (1)
change in the range of motion
This out come will be evaluated by physiotherapist using a device called a goniometer. A goniometer is a metal or plastic handheld device with two arms. Numbers representing angular distance are on the device, The physiotherapist measures the initial angular distance before the injection, and after the injection by 2 weeks Normal range of active movement of the shoulder has been specified by the American Academy of Orthopedic Surgeons (AAOS) to be 180° for flexion and abduction and 90° for external rotation.
Measured: 2 weeks after each injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2021
- Study start1 Mar 2021
- Primary completion30 Jul 2021
- Study completion3 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amr Abd Elfatah, proffeseor, Study director, department of anesthesia ,ICU, and pain management ASU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05043493
- Sponsor's protocol ID
- ASU 000017585
- Status last verified
- Feb 2021
- First submitted
- 18 Jul 2021
- Last updated
- 14 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Platelet Rich Plasma Therapy for Shoulder Osteoarthritis :Double Blinded Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05043493
- Acronym / sponsor ID
- ASU 000017585
- Conditions
- Shoulder Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 3 Aug 2021 (actual)
- First posted
- 14 Sep 2021 (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.
Patients with shoulder osteoarthritis are suffering from pain and disabilities which lead to difficulties in life. The presence of platelet-rich plasma as regenerative therapy which helps in healing of damaged tissues like ligaments and joint might be of great benefit in managing such conditions.
Detailed description
Primary and secondary osteoarthritis of the shoulder occurs due to destruction of the articular surface of the humeral head and glenoid , Patient mainly presented with pain and decreases in the range of motion .
Treatment of shoulder osteoarthritis is often controversial and is typically based on the patient's age, the severity of symptoms, and level of activity, radiographic findings, and medical comorbidities.
The new era of management include regenerative therapy ,Platelet-rich plasma (PRP) is one of the regenerative therapy that prove its effect as injections of a concentration of a patient's own platelets to accelerate the healing of injured tendons, ligaments, muscles and joints.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Injection (study) group | Active comparator | Procedure: Injection in the intraarticular space of glenohumeral jointThis group will receive platelet rich plasma (PRP) injection |
| Control group | Placebo comparator | Procedure: Injection in the intraarticular space of glenohumeral jointThis group will receive normal saline (NS) injection |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient's age: From 21 years.
- Acute symptoms on a background of at least a 3-month history of chronic pain or swelling of the shoulder joint with radiological confirmed (X-ray or MRI)
- Mild or moderate osteoarthritis of the shoulder joint according to The Samilson-Prieto classification.
- Numerical Rating Scale for pain scores greater than five on a 10 scale
Key exclusion criteria (8 listed)
- Under 21 years of age
- Severe osteoarthritis according to The Samilson-Prieto classification. (Figure 1)
- Neuropsychiatric disorders.
- Immunocompromised patients.
- Active infection or malignancy at the 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 |
|---|---|---|
| Injection in the intraarticular space of glenohumeral jointU/S guided injection of platelet rich plasma (PRP) or normal saline (NS) | Procedure or surgery | Control group, Injection (study) group |
Primary outcome
Change in patient's pain score
Time frame: 2 weeks after each injection
By using NUMERICAL PAIN SCALE patient will mention them pain score on scale from 1 to 10, where the pain score to be included in the study is 5 and more , we will measure pain score for each patient after 2 weeks from injection ,where decrease of the number from the initial recorded number before injection means improvement.
1 secondary outcome
change in the range of motion
Time frame: 2 weeks after each injection
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 14 Sep 2021.
- Individual participant dataSharing planned: No
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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.
Amr Abd Elfatah, proffeseor study director
department of anesthesia ,ICU, and pain management ASU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Injection in the intraarticular space of glenohumeral joint in people with Shoulder Osteoarthritis, run by Ain Shams 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 4 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 14 Sep 2021. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Change in patient's pain score (time frame: 2 weeks after each injection). 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 14 Sep 2021.