Subacromial Impingement SyndromeNCT01123889
Treatment of the Rotator Cuff Disease With Platelet Rich Plasma Injection
A study testing platelet rich plasma injection and corticosteroid injection in people with Subacromial Impingement Syndrome and Partial Thickness Rotator Cuff Tear, run by Loma Linda University at 1 site in United States.
Trial summary
The purpose of this investigator initiated study is to clinically evaluate the efficacy of a new treatment for subacromial impingement syndrome and partial thickness rotator cuff tears. This treatment consists of a platelet rich plasma injection into and around the rotator cuff. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Subacromial Impingement Syndrome, Partial Thickness Rotator Cuff Tear
- What is being tested?
- platelet rich plasma injection and corticosteroid injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to May 2011
- 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 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients presenting with rotator cuff symptoms for at least 4 weeks
- Examination reveals diffuse pain with provocative maneuvers
- Impingement symptoms with or without a partial thickness tear (if available MRI study must be less than 50% tear)
- Willingness to participate in an investigational technique
- Willingness to forgo any other concomitant conservative treatment modality including NSAID (must be stopped for at least one week)
Who cannot join
- Previous rotator cuff repair
- Complete rotator cuff tear or two tendon tears
- Pt w/ complex regional pain syndrome
- Cervical neuropathy or other nerve pathology
- RA, local or systemic infection, PVD, metabolic disease such as gout, clotting disorder, anticoagulation therapy
- Evidence of intraarticular arthritis
Show all 9Show fewer
- Work related or compensable injury
- Previous treatment: corticosteroid injection in the last 6 months
- Patients who are currently pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Rotator Cuff Syndrome With Injection of Autologous Platelet Rich Plasma
The purpose of this investigator initiated study is to clinically evaluate the efficacy of a new treatment for subacromial impingement syndrome and partial thickness rotator cuff tears. This treatment consists of a platelet rich plasma injection into and around the rotator cuff. It is thought that this treatment will dramatically improve outcomes for patients suffering from these two conditions.
Subjects will be randomized by choosing a slip of paper from an envelope. This process will randomize 25 patients to the experimental group, and 25 patients to the control. The experimental group will undergo a blood draw, allowing for an injection of platelet rich plasma around the rotator cuff. The control group will undergo a corticosteroid injection into the subacromial space surrounding the rotator cuff as sole treatment. Patients will be followed for three months for pain, and will fill out questionnaires at six weeks and three months post injection, which will give insight into functionality and pain changes that the rotator cuff is experiencing due to treatment.
Read more
Subjects will be outpatients. Subjects may include employees, students, minorities, and elderly, although no subsets of these will be formed.
Subjects will be between 18 and 89 years of age.
In total, subject participation will last approximately 3 months.
- Being tested
- platelet rich plasma injection, corticosteroid injection
- Keywords
- subacromial impingement, partial thickness rotator cuff, PRP, platelet rich plasma
- Medical subject headings
- Shoulder Impingement Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
platelet rich plasma injectionBiological
Also called platelet rich plasma - PRP, naropin, xylocaine
45 ml of a patient's own blood will be collected via blood draw, maintaining sterile technique. This will then be spun down using a Magellan Autologous Platelet Separator System, yielding platelet rich plasma (PRP). Under sterile conditions, patients will receive a 5 cc PRP injection (consisting of their own PRP) with 1 cc of 1% lidocaine and 1 cc of 0.5% ropivacaine into the subacromial space, administered by an orthopedic surgeon. This will be done using a posterior lateral approach. The patient will be monitored for 10 minutes in clinic for adverse reactions.
corticosteroid injectionDrug
Also called triamcinalone, naropin, xylocaine
Under sterile conditions, patients will receive a 5cc injection consisting of 2cc 1% lidocaine, 2cc 0.5% ropivacaine, and 1cc kenalog corticosteroid (40mg/cc) into the subacromial space utilizing a posterior lateral approach. Patients will be observed for 10 min in clinic for any adverse reactions.
| Study group | Role | What they receive |
|---|---|---|
| control | Active comparator | corticosteroid injection into subacromial space Receives: Drug: corticosteroid injection |
| experimental | Experimental | patients will receive an injection of platelet rich plasma into the subacromial space Receives: Biological: platelet rich plasma injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain and Disability of the Shoulder Through Validated Questionnaires
Patients will be asked to fill out questionnaires to provide insight into how their condition is progressing, consisting of components of the American Shoulder and Elbow Surgeons (ASES) total score. The maximum score is 100, made up by pain and function components' sums. Only the total score is recorded, 100 being full normal function without pain, 0 being severe pain and no function.
Measured: 6 weeks from initial injection of corticosteroid versus platelet rich plasma
Pain and Disability of the Shoulder Through Validated Questionnaires
Patients will be asked to fill out questionnaires to provide insight into how their condition is progressing, consisting of components of the American Shoulder and Elbow Surgeons (ASES) total score. The maximum score is 100, made up by pain and function components' sums. Only the total score is recorded, 100 being full normal function without pain, 0 being severe pain and no function.
Measured: 12 weeks from initial injection of corticosteroid versus platelet rich plasma
Pain and Disability of the Shoulder Through Validated Questionnaires
Patients will be asked to fill out questionnaires to provide insight into how their condition is progressing, consisting of components of the American Shoulder and Elbow Surgeons (ASES) total score. The maximum score is 100, made up by pain and function components' sums. Only the total score is recorded, 100 being full normal function without pain, 0 being severe pain and no function.
Measured: 15 minutes prior to initial injection of corticosteroid versus platelet rich plasma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2010 (estimated)
- Study startMay 2010
- Primary completionMay 2011
- Study completionMay 2011
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.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Subacromial Impingement SyndromeStudies of the same condition, open and under way.
- More trials run by Loma Linda 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
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Montri D. Wongworawat, Loma Linda University
- Investigators
- Montri D Wongworawat, MD, Principal investigator, Loma Linda University Department of Orthopedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01123889
- Sponsor's protocol ID
- 59322
- Status last verified
- Dec 2013
- First submitted
- 20 Apr 2010
- Last updated
- 11 Feb 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Fukuda H. The management of partial-thickness tears of the rotator cuff. J Bone Joint Surg Br. 2003 Jan;85(1):3-11. doi: 10.1302/0301-620x.85b1.13846. No abstract available.
PubMed 12585570Blair B, Rokito AS, Cuomo F, Jarolem K, Zuckerman JD. Efficacy of injections of corticosteroids for subacromial impingement syndrome. J Bone Joint Surg Am. 1996 Nov;78(11):1685-9. doi: 10.2106/00004623-199611000-00007.
PubMed 8934482Mishra A, Pavelko T. Treatment of chronic elbow tendinosis with buffered platelet-rich plasma. Am J Sports Med. 2006 Nov;34(11):1774-8. doi: 10.1177/0363546506288850. Epub 2006 May 30.
PubMed 16735582Buchbinder R, Green S, Youd JM. Corticosteroid injections for shoulder pain. Cochrane Database Syst Rev. 2003;2003(1):CD004016. doi: 10.1002/14651858.CD004016.
PubMed 12535501
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Rotator Cuff Syndrome With Injection of Autologous Platelet Rich Plasma
- ClinicalTrials.gov ID
- NCT01123889
- Acronym / sponsor ID
- 59322
- Keywords
- subacromial impingement, partial thickness rotator cuff, PRP, platelet rich plasma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 14 May 2010 (estimated)
- Results
- Posted 11 Feb 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this investigator initiated study is to clinically evaluate the efficacy of a new treatment for subacromial impingement syndrome and partial thickness rotator cuff tears. This treatment consists of a platelet rich plasma injection into and around the rotator cuff. It is thought that this treatment will dramatically improve outcomes for patients suffering from these two conditions.
Subjects will be randomized by choosing a slip of paper from an envelope. This process will randomize 25 patients to the experimental group, and 25 patients to the control. The experimental group will undergo a blood draw, allowing for an injection of platelet rich plasma around the rotator cuff. The control group will undergo a corticosteroid injection into the subacromial space surrounding the rotator cuff as sole treatment. Patients will be followed for three months for pain, and will fill out questionnaires at six weeks and three months post injection, which will give insight into functionality and pain changes that the rotator cuff is experiencing due to treatment.
Subjects will be outpatients. Subjects may include employees, students, minorities, and elderly, although no subsets of these will be formed.
Subjects will be between 18 and 89 years of age.
In total, subject participation will last approximately 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | Active comparator | Drug: corticosteroid injectioncorticosteroid injection into subacromial space |
| experimental | Experimental | Biological: platelet rich plasma injectionpatients will receive an injection of platelet rich plasma into the subacromial space |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients presenting with rotator cuff symptoms for at least 4 weeks
- Examination reveals diffuse pain with provocative maneuvers
- Impingement symptoms with or without a partial thickness tear (if available MRI study must be less than 50% tear)
- Willingness to participate in an investigational technique
- Willingness to forgo any other concomitant conservative treatment modality including NSAID (must be stopped for at least one week)
Key exclusion criteria (9 listed)
- Previous rotator cuff repair
- Complete rotator cuff tear or two tendon tears
- Pt w/ complex regional pain syndrome
- Cervical neuropathy or other nerve pathology
- RA, local or systemic infection, PVD, metabolic disease such as gout, clotting disorder, 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 |
|---|---|---|
| platelet rich plasma injectionAlso: platelet rich plasma - PRP, naropin, xylocaine45 ml of a patient's own blood will be collected via blood draw, maintaining sterile technique. This will then be spun down using a Magellan Autologous Platelet Separator System, yielding platelet rich plasma (PRP). Under sterile conditions, patients will receive a 5 cc PRP injection (consisting of their own PRP) with 1 cc of 1% lidocaine and 1 cc of 0.5% ropivacaine into the subacromial space, administered by an orthopedic surgeon. This will be done using a posterior lateral approach. The patient will be monitored for 10 minutes in clinic for adverse reactions. | Biological | experimental |
| corticosteroid injectionAlso: triamcinalone, naropin, xylocaineUnder sterile conditions, patients will receive a 5cc injection consisting of 2cc 1% lidocaine, 2cc 0.5% ropivacaine, and 1cc kenalog corticosteroid (40mg/cc) into the subacromial space utilizing a posterior lateral approach. Patients will be observed for 10 min in clinic for any adverse reactions. | Drug | control |
Primary outcome
Pain and Disability of the Shoulder Through Validated Questionnaires
Time frame: 6 weeks from initial injection of corticosteroid versus platelet rich plasma
Patients will be asked to fill out questionnaires to provide insight into how their condition is progressing, consisting of components of the American Shoulder and Elbow Surgeons (ASES) total score. The maximum score is 100, made up by pain and function components' sums. Only the total score is recorded, 100 being full normal function without pain, 0 being severe pain and no function.
Pain and Disability of the Shoulder Through Validated Questionnaires
Time frame: 12 weeks from initial injection of corticosteroid versus platelet rich plasma
Patients will be asked to fill out questionnaires to provide insight into how their condition is progressing, consisting of components of the American Shoulder and Elbow Surgeons (ASES) total score. The maximum score is 100, made up by pain and function components' sums. Only the total score is recorded, 100 being full normal function without pain, 0 being severe pain and no function.
Pain and Disability of the Shoulder Through Validated Questionnaires
Time frame: 15 minutes prior to initial injection of corticosteroid versus platelet rich plasma
Patients will be asked to fill out questionnaires to provide insight into how their condition is progressing, consisting of components of the American Shoulder and Elbow Surgeons (ASES) total score. The maximum score is 100, made up by pain and function components' sums. Only the total score is recorded, 100 being full normal function without pain, 0 being severe pain and no function.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 12585570Fukuda H. The management of partial-thickness tears of the rotator cuff. J Bone Joint Surg Br. 2003 Jan;85(1):3-11. doi: 10.1302/0301-620x.85b1.13846. No abstract available.
- Background: PubMed 8934482Blair B, Rokito AS, Cuomo F, Jarolem K, Zuckerman JD. Efficacy of injections of corticosteroids for subacromial impingement syndrome. J Bone Joint Surg Am. 1996 Nov;78(11):1685-9. doi: 10.2106/00004623-199611000-00007.
- Background: PubMed 16735582Mishra A, Pavelko T. Treatment of chronic elbow tendinosis with buffered platelet-rich plasma. Am J Sports Med. 2006 Nov;34(11):1774-8. doi: 10.1177/0363546506288850. Epub 2006 May 30.
- Background: PubMed 12535501Buchbinder R, Green S, Youd JM. Corticosteroid injections for shoulder pain. Cochrane Database Syst Rev. 2003;2003(1):CD004016. doi: 10.1002/14651858.CD004016.
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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.
Montri D Wongworawat, MD principal investigator
Loma Linda University Department of Orthopedics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing platelet rich plasma injection and corticosteroid injection in people with Subacromial Impingement Syndrome and Partial Thickness Rotator Cuff Tear, run by Loma Linda University 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 5 inclusion and 9 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 11 Feb 2014. 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 11 Feb 2014). 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?
Pain and Disability of the Shoulder Through Validated Questionnaires (time frame: 6 weeks from initial injection of corticosteroid versus platelet rich plasma). The study lists 3 primary outcomes in all. 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 NCT01123889, which also lists 4 linked publications.
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 11 Feb 2014.