Rotator Cuff InjuriesPhase 4PRPNCT04743986
The Effect of Platelet Rich Plasma on Partial Thickness Rotator Cuff Tears: A Randomized Controlled Trial
A Phase 4 study testing Platelet Rich Plasma (PRP) and Corticosteroid (CS) in people with Rotator Cuff Injuries, run by University of Calgary.
Trial summary
Randomized controlled trial examining platelet rich plasma versus corticosteroid injection in partial thickness rotator cuff tears or tendinopathy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rotator Cuff Injuries
- What is being tested?
- Platelet Rich Plasma (PRP) and Corticosteroid (CS)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- No sites listed yet
- Study dates
- 13 Mar 2015to 6 Jun 2019
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >18 years
- MRI or US evidence of supraspinatus tendinopathy or partial thickness tearing
- symptomatic for minimum of 3 months
- patient has exhausted a course of adequate conservative treatment (including but not limited to home/out patient physical therapy, oral analgesics, and/or shoulder injections)
Who cannot join
- prior surgical intervention on affected shoulder
- full thickness rotator cuff tear
- concomitant ipsilateral shoulder pathology (i.e. osteoarthritis, inflammatory arthritis)
- confounding cervical neck pain or radiculopathy
- more than 3 previous CS injections
- a CS injection within 6 months of study intervention
Show all 10Show fewer
- elite level athlete
- worker's compensation case
- litigation or secondary gain issues
- unwilling or unable to provide informed consent or complete study outcomes
About this study
Randomized controlled trial examining platelet rich plasma versus corticosteroid injection in partial thickness rotator cuff tears or tendinopathy.
Read the detailed description
We performed a randomized controlled trial on patients with imaging-shown rotator cuff tendinopathy or partial thickness tearing. Patients were randomized to receive either platelet rich plasma or corticosteroid. Follow-up was done at 6 weeks, 3 months and 12 months following injection.
- Conditions
- Rotator Cuff Injuries
- Being tested
- Platelet Rich Plasma (PRP), Corticosteroid (CS)
- Keywords
- corticosteroid, platelet rich plasma, tendinopathy, partial thickness tear
- Medical subject headings
- Rotator Cuff Injuries, Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet Rich Plasma (PRP)Biological
RegenLab, Lausanne, Switzerland
Corticosteroid (CS)Drug
40mg/ml triamcinolone in 2 ml 0.5% bupivicaine
| Study group | Role | What they receive |
|---|---|---|
| Platelet Rich Plasma (PRP) | Experimental | Patients had 10ml venous blood drawn. Injection was performed under ultrasound guidance by one of two musculoskeletal radiologists. Injection was 3-5ml at the site of tendon pathology with the remainder of the PRP preparation infiltrated into the subacromial space. A leukocyte-poor preparation was used from a pre-packaged kit (RegenLab, Lausanne, Switzerland). The samples were centrifuged at 1500g for 5 mins to yield approx 5.5ml of 80% platelets at 1.6x concentration. The supernatant was then resuspended by inverting the tube several times and was drawn into a separate 5-ml syringe for subacromial injection. Receives: Biological: Platelet Rich Plasma (PRP) |
| Corticosteroid (CS) | Active comparator | Patients had 10ml venous blood drawn. Injection was performed under ultrasound guidance by one of two musculoskeletal radiologists. The blood sample was kept for a similar time delay for centrifugation prior to injection, and was then discarded. 1ml of 40-mg/ml triamcinolone was suspended in 2ml of 0.5% bupivicaine. Injection was performed through a lateral subacromial approach after needle fenestration of the supraspinatus tendon under ultrasound visualization. CS was infiltrated into the subacromial bursa and not the tendon itself. Receives: Drug: Corticosteroid (CS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
visual analog scale for pain
Measured: change from baseline at 6 weeks, 3 months, 12 months
Secondary outcomes (4)
American Shoulder and Elbow Surgeons shoulder score (ASES)
ASES score
Measured: change from baseline at 6 weeks, 3 months, 12 months
Western Ontario Rotator Cuff Index (WORC)
WORC score
Measured: change from baseline at 6 weeks, 3 months, 12 months
"Failure"
- patient request for a subsequent injection, 2) consent for surgical repair, 3) undergoing surgery
Measured: anytime from injection out to 12 months
Anatomic changes
ultrasound evidence of progression to a full thickness tear
Measured: 3 months and 12 months post injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2021
- Study start13 Mar 2015
- Primary completion6 Jun 2019
- Study completion6 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff InjuriesStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two arm parallel randomized controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ian King Yeung Lo, University of Calgary
- Investigators
- Ian KY Lo, MD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04743986
- Sponsor's protocol ID
- REB14-0570
- Acronym
- PRP
- Status last verified
- Feb 2021
- First submitted
- 3 Feb 2021
- Last updated
- 8 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- No: No individual participant data will be made available.
Publications
Kwong CA, Woodmass JM, Gusnowski EM, Bois AJ, Leblanc J, More KD, Lo IKY. Platelet-Rich Plasma in Patients With Partial-Thickness Rotator Cuff Tears or Tendinopathy Leads to Significantly Improved Short-Term Pain Relief and Function Compared With Corticosteroid Injection: A Double-Blind Randomized Controlled Trial. Arthroscopy. 2021 Feb;37(2):510-517. doi: 10.1016/j.arthro.2020.10.037. Epub 2020 Oct 28.
PubMed 33127554
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Platelet Rich Plasma on Partial Thickness Rotator Cuff Tears: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04743986
- Acronym / sponsor ID
- PRP / REB14-0570
- Conditions
- Rotator Cuff Injuries
- Keywords
- corticosteroid, platelet rich plasma, tendinopathy, partial thickness tear
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 13 Mar 2015 (actual)
- Primary completion
- 6 Jun 2019 (actual)
- Study completion
- 6 Jun 2019 (actual)
- First posted
- 8 Feb 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.
Randomized controlled trial examining platelet rich plasma versus corticosteroid injection in partial thickness rotator cuff tears or tendinopathy.
Detailed description
We performed a randomized controlled trial on patients with imaging-shown rotator cuff tendinopathy or partial thickness tearing. Patients were randomized to receive either platelet rich plasma or corticosteroid. Follow-up was done at 6 weeks, 3 months and 12 months following injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two arm parallel randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Platelet Rich Plasma (PRP) | Experimental | Biological: Platelet Rich Plasma (PRP)Patients had 10ml venous blood drawn. Injection was performed under ultrasound guidance by one of two musculoskeletal radiologists. Injection was 3-5ml at the site of tendon pathology with the remainder of the PRP preparation infiltrated into the subacromial space. A leukocyte-poor preparation was used from a pre-packaged kit (RegenLab, Lausanne, Switzerland). The samples were centrifuged at 1500g for 5 mins to yield approx 5.5ml of 80% platelets at 1.6x concentration. The supernatant was then resuspended by inverting the tube several times and was drawn into a separate 5-ml syringe for subacromial injection. |
| Corticosteroid (CS) | Active comparator | Drug: Corticosteroid (CS)Patients had 10ml venous blood drawn. Injection was performed under ultrasound guidance by one of two musculoskeletal radiologists. The blood sample was kept for a similar time delay for centrifugation prior to injection, and was then discarded. 1ml of 40-mg/ml triamcinolone was suspended in 2ml of 0.5% bupivicaine. Injection was performed through a lateral subacromial approach after needle fenestration of the supraspinatus tendon under ultrasound visualization. CS was infiltrated into the subacromial bursa and not the tendon itself. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- >18 years
- MRI or US evidence of supraspinatus tendinopathy or partial thickness tearing
- symptomatic for minimum of 3 months
- patient has exhausted a course of adequate conservative treatment (including but not limited to home/out patient physical therapy, oral analgesics, and/or shoulder injections)
Key exclusion criteria (10 listed)
- prior surgical intervention on affected shoulder
- full thickness rotator cuff tear
- concomitant ipsilateral shoulder pathology (i.e. osteoarthritis, inflammatory arthritis)
- confounding cervical neck pain or radiculopathy
- more than 3 previous CS injections
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 Plasma (PRP)RegenLab, Lausanne, Switzerland | Biological | Platelet Rich Plasma (PRP) |
| Corticosteroid (CS)40mg/ml triamcinolone in 2 ml 0.5% bupivicaine | Drug | Corticosteroid (CS) |
Primary outcome
Visual Analog Scale (VAS)
Time frame: change from baseline at 6 weeks, 3 months, 12 months
visual analog scale for pain
4 secondary outcomes
American Shoulder and Elbow Surgeons shoulder score (ASES)
Time frame: change from baseline at 6 weeks, 3 months, 12 months
Western Ontario Rotator Cuff Index (WORC)
Time frame: change from baseline at 6 weeks, 3 months, 12 months
"Failure"
Time frame: anytime from injection out to 12 months
Anatomic changes
Time frame: 3 months and 12 months post 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 8 Feb 2021.
- Background: PubMed 33127554Kwong CA, Woodmass JM, Gusnowski EM, Bois AJ, Leblanc J, More KD, Lo IKY. Platelet-Rich Plasma in Patients With Partial-Thickness Rotator Cuff Tears or Tendinopathy Leads to Significantly Improved Short-Term Pain Relief and Function Compared With Corticosteroid Injection: A Double-Blind Randomized Controlled Trial. Arthroscopy. 2021 Feb;37(2):510-517. doi: 10.1016/j.arthro.2020.10.037. Epub 2020 Oct 28.
- Individual participant dataSharing planned: No. No individual participant data will be made available.
Related trials for Rotator Cuff Injuries
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Active, not recruitingPhase 1
E-CEL UVEC Cells as an Adjunct Cell Therapy for the Arthroscopic Rotator Cuff Repair in Adults
Rotator Cuff Tears, Muscle Atrophy or Weakness
Active, not recruitingObservational study
Natural History of Shoulder Pathology in Manual Wheelchair Users
Paraplegia, Spinal Cord Injuries
Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
Active, not recruiting
BioBrace® Implant for Arthroscopic Repair of Full Thickness Rotator Cuff Tears
Rotator Cuff Tears
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.
Ian KY Lo, MD principal investigator
University of Calgary
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Platelet Rich Plasma (PRP) and Corticosteroid (CS) in people with Rotator Cuff Injuries, run by University of Calgary.
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 10 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 8 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Visual Analog Scale (VAS) (time frame: change from baseline at 6 weeks, 3 months, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04743986, which also lists 1 linked publication.
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 8 Feb 2021.