Partial Tear of Rotator CuffNCT02246530
Non-Surgical Treatment for Rotator-Cuff Tears Using Platelet-Rich-Plasma
A study testing PRP injection into PTRCT and Subacromial steroid bursal injection in people with Partial Tear of Rotator Cuff and Tendinopathy of Rotator Cuff, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The goal of this project is to identify an effective and conservative approach to treating partial thickness rotator cuff tears (PTRCT) that otherwise would end with a surgical correction needed. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Partial Tear of Rotator Cuff, Tendinopathy of Rotator Cuff
- What is being tested?
- PRP injection into PTRCT and Subacromial steroid bursal injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Mar 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- subjects between ages 19 to 75, both male and female
- radiologic imaging which can include either magnetic resonance imaging (MRI) or ultrasound (US) consistent with partial thickness rotator cuff tears of any degree except for full thickness tears
- Failed a trial of physical therapy of at least 4 weeks
Who cannot join
- Full thickness tears (well documented need for surgical correction)
- sensory or neurologic complaint affecting the shoulder of interest
- Coagulation disorder, platelet disorder
- Pregnancy: Pregnancy test will be performed on women of childbearing age prior to their participation in the interventional portion of the study
- Any major systemic illness such as ongoing infection or any condition that requires strict anti-platelet or anticoagulation therapy
- Prior surgery to either cervical spine or shoulder
- Active military
- Injury part of worker compensation claim
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this project is to identify an effective and conservative approach to treating partial thickness rotator cuff tears (PTRCT) that otherwise would end with a surgical correction needed.
Read the detailed description
Based off literature and clinical practice, the majority of rotator cuff tears continue to progress to surgical correction despite conservative measures. These include physical therapy, medication management and minimally invasive procedures such as subacromial bursa injections and intra-articular injections with steroids. Recently a popular treatment of common musculoskeletal injuries (including tendinopathies) has emerged throughout the US and has been utilized worldwide for many years with good empiric evidence known as Platelet-Rich Plasma (PRP) injections. In partnership with UAB Orthopedics and Radiology, the UAB Department of Physical Medicine and Rehabilitation aims to compare PRP to corticosteroid injections for patients with partial rotator cuff tears or tendinopathy. Outcome measures are ultrasound imaging, pain and disability over the course of 6 months.
- Being tested
- PRP injection into PTRCT, Subacromial steroid bursal injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRP injection into PTRCTProcedure or surgery
Also called Biologics
Day of procedure, 60 cc blood draw will be taken for processing and isolation of PRP. PRP sample will be injected peri-tendinous / intra-tendinous area at location of the PTRCT under ultrasound guidance to ensure accurate placement at site of injury.
PRP is an autologous blood product that is being re-injected into the same patient and is considered a non-invasive interventional procedure. PRP is classified as a procedure and not a drug.
Subacromial steroid bursal injectionDrug
Also called Procedure
Combination steroid (Celestone) and anesthetic drug (Lidocaine) will be injected into the patient's subacromial bursa via needle guidance of ultrasound
| Study group | Role | What they receive |
|---|---|---|
| PRP injection into PTRCT | Active comparator | Treatment - PRP injection Receives: Procedure: PRP injection into PTRCT |
| Subacromial steroid bursal injection | Active comparator | Current standard of care for treatment of resistant partial thickness rotator cuff tears Receives: Drug: Subacromial steroid bursal injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Ultrasound
Comparing baseline diagnostic ultrasound for structural changes. An initial diagnostic ultrasound image was obtained to demonstrate a tear of the supraspinatus tendon, a key tendon of the rotator cuff. Once a tear of this tendon was confirmed, patient were delegated to one of the study arms and proceeded to the injection phase of the study.
Two subject's data (within the PRP group) is incomplete as these subjects were lost to follow up and do not have completed 6 month follow up ultrasound imaging to review.
Measured: 6 months post procedure
Secondary outcomes (3)
Shoulder Pain and Disability Index
Comparing the questionnaire Shoulder Pain and Disability Index (SPADI) Scores to assess improvement after intervention. The SPADI is a self-administered questionnaire that addressed pain and disability in functional activities. The raw score ranges from 0 (no pain or disability) to 130 (highest pain in each pain category and highest difficulty in each functional category). The SPADI Score is then calculated as a percentage (raw score / 130). Thus, the final score is a range of 0% to 100%.
In the PRP (platelet rich plasma injection) group we had 5 participants completed the study.
2 participants in the control (corticosteroid injection) group completed the study.
Measured: Week 3 post procedure SPADI Scores for the control and treatment groups.
Shoulder Pain and Disability Index
Comparing the questionnaire Shoulder Pain and Disability Index (SPADI) Scores to assess improvement after intervention. The SPADI is a self-administered questionnaire that addressed pain and disability in functional activities. The raw score ranges from 0 (no pain or disability) to 130 (highest pain in each pain category and highest difficulty in each functional category). The SPADI Score is then calculated as a percentage (raw score / 130). Thus, the final score is a range of 0% to 100%.
In the PRP (platelet rich plasma injection) group we had 5 participants completed the study.
2 participants in the control (corticosteroid injection) group completed the study.
Measured: Week 6 post procedure SPADI Scores for the treatment and control groups.
Shoulder Pain and Disability Index
Comparing the questionnaire Shoulder Pain and Disability Index (SPADI) Scores to assess improvement after intervention. The SPADI is a self-administered questionnaire that addressed pain and disability in functional activities. The raw score ranges from 0 (no pain or disability) to 130 (highest pain in each pain category and highest difficulty in each functional category). The SPADI Score is then calculated as a percentage (raw score / 130). Thus, the final score is a range of 0% to 100%.
In the PRP (platelet rich plasma injection) group we had 5 participants completed the study.
2 participants in the control (corticosteroid injection) group completed the study.
Measured: 6 months post procedure SPADI scores for the treatment and control groups.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2014 (estimated)
- Study startJul 2014
- Primary completionJan 2021
- Study completionMar 2021
Why it stopped: Study terminated prematurely due to inability to complete recruitment of subjects for each of the trial groups (treatment and control).
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Partial Tear of Rotator CuffStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Breanna Willeford, University of Alabama at Birmingham
- Investigators
- Breanna Willeford, DO, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02246530
- Sponsor's protocol ID
- F131231006
- Status last verified
- May 2022
- First submitted
- 21 Aug 2014
- Last updated
- 16 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Surgical Treatment for Rotator-Cuff Tears Using Platelet-Rich-Plasma
- ClinicalTrials.gov ID
- NCT02246530
- Acronym / sponsor ID
- F131231006
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated prematurely due to inability to complete recruitment of subjects for each of the trial groups (treatment and control).
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Jul 2014 (actual)
- Primary completion
- Jan 2021 (actual)
- Study completion
- Mar 2021 (actual)
- First posted
- 22 Sep 2014 (estimated)
- Results
- Posted 16 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this project is to identify an effective and conservative approach to treating partial thickness rotator cuff tears (PTRCT) that otherwise would end with a surgical correction needed.
Detailed description
Based off literature and clinical practice, the majority of rotator cuff tears continue to progress to surgical correction despite conservative measures. These include physical therapy, medication management and minimally invasive procedures such as subacromial bursa injections and intra-articular injections with steroids. Recently a popular treatment of common musculoskeletal injuries (including tendinopathies) has emerged throughout the US and has been utilized worldwide for many years with good empiric evidence known as Platelet-Rich Plasma (PRP) injections. In partnership with UAB Orthopedics and Radiology, the UAB Department of Physical Medicine and Rehabilitation aims to compare PRP to corticosteroid injections for patients with partial rotator cuff tears or tendinopathy. Outcome measures are ultrasound imaging, pain and disability over the course of 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRP injection into PTRCT | Active comparator | Procedure: PRP injection into PTRCTTreatment - PRP injection |
| Subacromial steroid bursal injection | Active comparator | Drug: Subacromial steroid bursal injectionCurrent standard of care for treatment of resistant partial thickness rotator cuff tears |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- subjects between ages 19 to 75, both male and female
- radiologic imaging which can include either magnetic resonance imaging (MRI) or ultrasound (US) consistent with partial thickness rotator cuff tears of any degree except for full thickness tears
- Failed a trial of physical therapy of at least 4 weeks
Key exclusion criteria (8 listed)
- Full thickness tears (well documented need for surgical correction)
- sensory or neurologic complaint affecting the shoulder of interest
- Coagulation disorder, platelet disorder
- Pregnancy: Pregnancy test will be performed on women of childbearing age prior to their participation in the interventional portion of the study
- Any major systemic illness such as ongoing infection or any condition that requires strict anti-platelet or anticoagulation therapy
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 |
|---|---|---|
| PRP injection into PTRCTAlso: BiologicsDay of procedure, 60 cc blood draw will be taken for processing and isolation of PRP. PRP sample will be injected peri-tendinous / intra-tendinous area at location of the PTRCT under ultrasound guidance to ensure accurate placement at site of injury. PRP is an autologous blood product that is being re-injected into the same patient and is considered a non-invasive interventional procedure. PRP is classified as a procedure and not a drug. | Procedure or surgery | PRP injection into PTRCT |
| Subacromial steroid bursal injectionAlso: ProcedureCombination steroid (Celestone) and anesthetic drug (Lidocaine) will be injected into the patient's subacromial bursa via needle guidance of ultrasound | Drug | Subacromial steroid bursal injection |
Primary outcome
Diagnostic Ultrasound
Time frame: 6 months post procedure
Comparing baseline diagnostic ultrasound for structural changes. An initial diagnostic ultrasound image was obtained to demonstrate a tear of the supraspinatus tendon, a key tendon of the rotator cuff. Once a tear of this tendon was confirmed, patient were delegated to one of the study arms and proceeded to the injection phase of the study. Two subject's data (within the PRP group) is incomplete as these subjects were lost to follow up and do not have completed 6 month follow up ultrasound imaging to review.
3 secondary outcomes
Shoulder Pain and Disability Index
Time frame: Week 3 post procedure SPADI Scores for the control and treatment groups.
Shoulder Pain and Disability Index
Time frame: Week 6 post procedure SPADI Scores for the treatment and control groups.
Shoulder Pain and Disability Index
Time frame: 6 months post procedure SPADI scores for the treatment and control groups.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Partial Tear of Rotator Cuff
Active, not recruiting
Lyophilized Platelet-Rich Plasma Lysate vs Dextrose Prolotherapy for Partial Rotator Cuff Tears
Rotator Cuff Tear, Rotator Cuff Syndrome
Recruiting
Arthroscopic Rotator Cuff Repair With Long Head of Biceps Transposition and Acellular Dermal Matrix Augmentation for Large to Massive Incompletely Repairable Rotator Cuff Tears
Rotator Cuff Tears, Rotator Cuff Injuries
Recruiting
Use of the REGENETEN™ Bioinductive Implant System in High Grade Partial-thickness Tears
Rotator Cuff Injuries
Recruiting
Effects Of Biceps Transposition Without Tenotomy For Augmentation Of Massive Rotator Cuff Repairs
Massive Rotator Cuff Tear
Recruiting
Concentric vs Eccentric Full Can Exercise in Partial Rotator Cuff Tears
Partial Rotator Cuff Tears, Rotator Cuff Injuries
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.
Breanna Willeford, DO principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRP injection into PTRCT and Subacromial steroid bursal injection in people with Partial Tear of Rotator Cuff and Tendinopathy of Rotator Cuff, run by University of Alabama at Birmingham at 1 site in United States.
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 3 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: stopped early, as of the sponsor's last update on 16 May 2022. 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 United States. 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?
Yes. Results are posted in the registry (first posted 16 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Diagnostic Ultrasound (time frame: 6 months post procedure). 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 16 May 2022.