Partial Tear of Rotator CuffNCT04681937
Comparison of Hyaluronic Acid, PRP and Steroid Injections in Partial Rotator Cuff Tears: A Prospective Randomized Study
A study testing Subacromial Injection (hyaluronic acid) + Physical Therapy., Subacromial Injection (Platelet-Rich-Plasma) + Physical Therapy. and Subacromial Injection (methylprednisolone acetate) + Physical Therapy. in people with Partial Tear of Rotator Cuff and Rotator Cuff Tears, run by Bezmialem Vakif University at 2 sites in Turkey (Türkiye).
Trial summary
There are many conservative treatment options available for partial rotator cuff tears. However, the superiority of a certain type of injection could not be demonstrated with the available data. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Partial Tear of Rotator Cuff, Rotator Cuff Tears
- What is being tested?
- Subacromial Injection (hyaluronic acid) + Physical Therapy., Subacromial Injection (Platelet-Rich-Plasma) + Physical Therapy. and Subacromial Injection (methylprednisolone acetate) + Physical Therapy.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Jun 2021to 15 Sep 2022
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- persistent continous pain at least 3 months
- partial thickness rotator cuff tear on MRI
Who cannot join
- inflammatory disease
- pregnancy
- known malignancy
- bleeding disorder ( or <10 g/dl Hb level, <150.000 ul platelet)
- previous shoulder injection
- history of shoulder surgery
- full-thickness tear
- other shoulder problem (osteoarthritis, bony lesions, etc)
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Bezmialem Vakif University
Istanbul, 34093
Bezmialem Vakif University
Istanbul, 34093
Vahdet Ucan, MD, +905546586750, vahdetucan@hotmail.com
About this study
Official title: Clinical and Radiological Comparison of the Efficacy of Hyaluronic Acid, PRP and Steroid Injections in Partial Rotator Cuff Tears: A Prospective Randomized Study
There are many conservative treatment options available for partial rotator cuff tears. However, the superiority of a certain type of injection could not be demonstrated with the available data. Our aim is to compare the effectiveness of steroid, hyaluronic acid, prp and placebo (normal saline) injections in partial rotator cuff tears by applying the same physical therapy protocol after injection.
- Conditions
- Partial Tear of Rotator Cuff, Rotator Cuff Tears
- Being tested
- Subacromial Injection (hyaluronic acid) + Physical Therapy., Subacromial Injection (Platelet-Rich-Plasma) + Physical Therapy., Subacromial Injection (methylprednisolone acetate) + Physical Therapy., Subacromial Injection (Serum Saline) + Physical Therapy.
- Keywords
- partial rotator cuff tear, subacromial injection, plateled-rich-plasma, physical therapy
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subacromial Injection (hyaluronic acid) + Physical Therapy.Combination product
arm1: sodium hyaluronate (4ml) arm2: platelet-rich-plasma (4ml) arm3: methylprednisolone acetate (1ml methylprednisolone acetate + 3 ml serum saline) arm4: serum saline (4ml) The same physical therapy procedure will be applied to all arms after injection.
Subacromial Injection (Platelet-Rich-Plasma) + Physical Therapy.Combination product
arm1: sodium hyaluronate (4ml) arm2: platelet-rich-plasma (4ml) arm3: methylprednisolone acetate (1ml methylprednisolone acetate + 3 ml serum saline) arm4: serum saline (4ml) The same physical therapy procedure will be applied to all arms after injection.
Subacromial Injection (methylprednisolone acetate) + Physical Therapy.Combination product
arm1: sodium hyaluronate (4ml) arm2: platelet-rich-plasma (4ml) arm3: methylprednisolone acetate (1ml methylprednisolone acetate + 3 ml serum saline) arm4: serum saline (4ml) The same physical therapy procedure will be applied to all arms after injection.
Subacromial Injection (Serum Saline) + Physical Therapy.Combination product
arm1: sodium hyaluronate (4ml) arm2: platelet-rich-plasma (4ml) arm3: methylprednisolone acetate (1ml methylprednisolone acetate + 3 ml serum saline) arm4: serum saline (4ml) The same physical therapy procedure will be applied to all arms after injection.
| Study group | Role | What they receive |
|---|---|---|
| Hyaluronic Acid + Physical Therapy | Experimental | 4 ml hyaluronic acid (subacromial) Receives: Combination Product: Subacromial Injection (hyaluronic acid) + Physical Therapy. |
| Platelet-Rich-Plasma (PRP) + Physical Therapy | Experimental | 4 ml platelet-rich-plasma (subacromial) Receives: Combination Product: Subacromial Injection (Platelet-Rich-Plasma) + Physical Therapy. |
| Steroid + Physical Therapy | Experimental | methylprednisolone acetate (1ml methylprednisolone acetate + 3 ml serum saline) (subacromial) Receives: Combination Product: Subacromial Injection (methylprednisolone acetate) + Physical Therapy. |
| Placebo (serum saline) + Physical Therapy | Experimental | 4 ml serum saline (subacromial) Receives: Combination Product: Subacromial Injection (Serum Saline) + Physical Therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
American Shoulder and Elbow Surgeons Shoulder Score (ASES)
minimum score:0, maximum score:100, 100 is better function.
Measured: 12 months after injection
Secondary outcomes (4)
Constant-Murley Shoulder Outcome Score (CMS)
minimum score:0, maximum score:100, 100 is better function.
Measured: 12 months after injection
Visual analogue scale (VAS)
minimum score:0, maximum score:10, 0 is better function
Measured: 12 months after injection
Subjective Shoulder Value (SSV)
minimum score:0, maximum score:100, 100 is better function.
Measured: 12 months after injection
Range of Motion (ROM)
Active Shoulder Range of Motion Measurements
Measured: 12 months after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study start1 Jun 2021 (estimated)
- Primary completion15 Nov 2021 (estimated)
- Study completion15 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Partial Tear of Rotator CuffStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif 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, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muzaffer Ağır, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04681937
- Sponsor's protocol ID
- 4350611
- Status last verified
- May 2021
- First submitted
- 13 Dec 2020
- Last updated
- 1 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiological Comparison of the Efficacy of Hyaluronic Acid, PRP and Steroid Injections in Partial Rotator Cuff Tears: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT04681937
- Acronym / sponsor ID
- 4350611
- Conditions
- Partial Tear of Rotator Cuff, Rotator Cuff Tears
- Keywords
- partial rotator cuff tear, subacromial injection, plateled-rich-plasma, physical therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- 15 Nov 2021 (estimated)
- Study completion
- 15 Sep 2022 (estimated)
- First posted
- 23 Dec 2020 (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.
There are many conservative treatment options available for partial rotator cuff tears. However, the superiority of a certain type of injection could not be demonstrated with the available data. Our aim is to compare the effectiveness of steroid, hyaluronic acid, prp and placebo (normal saline) injections in partial rotator cuff tears by applying the same physical therapy protocol after injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Hyaluronic Acid + Physical Therapy | Experimental | Combination Product: Subacromial Injection (hyaluronic acid) + Physical Therapy.4 ml hyaluronic acid (subacromial) |
| Platelet-Rich-Plasma (PRP) + Physical Therapy | Experimental | Combination Product: Subacromial Injection (Platelet-Rich-Plasma) + Physical Therapy.4 ml platelet-rich-plasma (subacromial) |
| Steroid + Physical Therapy | Experimental | Combination Product: Subacromial Injection (methylprednisolone acetate) + Physical Therapy.methylprednisolone acetate (1ml methylprednisolone acetate + 3 ml serum saline) (subacromial) |
| Placebo (serum saline) + Physical Therapy | Experimental | Combination Product: Subacromial Injection (Serum Saline) + Physical Therapy.4 ml serum saline (subacromial) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- persistent continous pain at least 3 months
- partial thickness rotator cuff tear on MRI
Key exclusion criteria (8 listed)
- inflammatory disease
- pregnancy
- known malignancy
- bleeding disorder ( or <10 g/dl Hb level, <150.000 ul platelet)
- previous shoulder injection
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 |
|---|---|---|
| Subacromial Injection (hyaluronic acid) + Physical Therapy.arm1: sodium hyaluronate (4ml) arm2: platelet-rich-plasma (4ml) arm3: methylprednisolone acetate (1ml methylprednisolone acetate + 3 ml serum saline) arm4: serum saline (4ml) The same physical therapy procedure will be applied to all arms after injection. | Combination product | Hyaluronic Acid + Physical Therapy |
| Subacromial Injection (Platelet-Rich-Plasma) + Physical Therapy.arm1: sodium hyaluronate (4ml) arm2: platelet-rich-plasma (4ml) arm3: methylprednisolone acetate (1ml methylprednisolone acetate + 3 ml serum saline) arm4: serum saline (4ml) The same physical therapy procedure will be applied to all arms after injection. | Combination product | Platelet-Rich-Plasma (PRP) + Physical Therapy |
| Subacromial Injection (methylprednisolone acetate) + Physical Therapy.arm1: sodium hyaluronate (4ml) arm2: platelet-rich-plasma (4ml) arm3: methylprednisolone acetate (1ml methylprednisolone acetate + 3 ml serum saline) arm4: serum saline (4ml) The same physical therapy procedure will be applied to all arms after injection. | Combination product | Steroid + Physical Therapy |
| Subacromial Injection (Serum Saline) + Physical Therapy.arm1: sodium hyaluronate (4ml) arm2: platelet-rich-plasma (4ml) arm3: methylprednisolone acetate (1ml methylprednisolone acetate + 3 ml serum saline) arm4: serum saline (4ml) The same physical therapy procedure will be applied to all arms after injection. | Combination product | Placebo (serum saline) + Physical Therapy |
Primary outcome
American Shoulder and Elbow Surgeons Shoulder Score (ASES)
Time frame: 12 months after injection
minimum score:0, maximum score:100, 100 is better function.
4 secondary outcomes
Constant-Murley Shoulder Outcome Score (CMS)
Time frame: 12 months after injection
Visual analogue scale (VAS)
Time frame: 12 months after injection
Subjective Shoulder Value (SSV)
Time frame: 12 months after injection
Range of Motion (ROM)
Time frame: 12 months after injection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2021.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subacromial Injection (hyaluronic acid) + Physical Therapy., Subacromial Injection (Platelet-Rich-Plasma) + Physical Therapy. and Subacromial Injection (methylprednisolone acetate) + Physical Therapy. in people with Partial Tear of Rotator Cuff and Rotator Cuff Tears, run by Bezmialem Vakif University at 2 sites in Turkey (Türkiye).
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: status not confirmed, as of the sponsor's last update on 1 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
American Shoulder and Elbow Surgeons Shoulder Score (ASES) (time frame: 12 months after 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 1 Jun 2021.