TendinosisPhase 2NCT01600326
A Prospective Comparison of Ultrasound-Guided Percutaneous Platelet-Rich Plasma Injection
A Phase 2 study testing Tenotomy (no injection) and Ultrasound guided platelet rich plasma injection in people with Tendinosis and Tendinitis, run by University of Michigan at 1 site in United States.
Trial summary
The purpose of this study is to determine the effectiveness of various treatment soft tendinosis also known as tendinitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tendinosis, Tendinitis
- What is being tested?
- Tenotomy (no injection) and Ultrasound guided platelet rich plasma injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Jul 2015
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult subjects with a diagnosis of tendinosis of the hip.
- Adult subjects who have been referred to Dr. Jacobson for the treatment of tendinosis by tenotomy.
Who cannot join
- pregnancy
- risk of bleeding due to anticoagulant medication
- presence of malignancy
- steroid injection less than 3 months before enrollment
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Hospital
Ann Arbor, Michigan, 48109
About this study
Official title: A Prospective Comparison of Ultrasound-Guided Percutaneous Platelet-Rich Plasma Injection Versus Tenotomy for Treatment of Gluteus Minimus and Medius Tendinosis
The purpose of this study is to determine the effectiveness of various treatment soft tendinosis also known as tendinitis.
Read the detailed description
Currently there are three treatments that are considered standard of care; rest, tenotomy and tenotomy with injections of platelet-rich plasma (PRP). Tenotomy is performed by passing a needle through the abnormal tendon repeatedly until the needle has passed through all areas of the abnormal tendon with softening of the tendon. Tenotomy with PRP injections is performed in the same manner but includes an injection of platelet-rich plasma (PRP) into the tendon. This study will evaluate the effectiveness of tenotomy versus PRP treatment.
- Conditions
- Tendinosis, Tendinitis
- Being tested
- Tenotomy (no injection), Ultrasound guided platelet rich plasma injection
- Medical subject headings
- Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenotomy (no injection)Procedure or surgery
Subjects randomized to this group will fill out a pre-treatment pain survey and have a blood draw They will be be contacted by the investigator by telephone or email on day 7 and day 14 to complete another pain survey. Subjects must avoid non steroidal anti-inflammatory medications for 2 weeks before the study. Two weeks after enrollment subjects see their referring physician to begin physical therapy.
Ultrasound guided platelet rich plasma injectionDrug
Subjects will fill out a pre-treatment pain survey, then will undergo ultrasound and have blood drawn from their arm.
The blood sample will be separated into blood cells and plasma. The plasma portion of the blood (liquid minus the cells) will be injected into the tendon under sterile conditions. Ultrasound will help guide the injection. This is called "Ultrasound guided platelet rich plasma injection."
Subjects will be be contacted by the investigator by telephone or email on day 7 and day 14 to complete another pain survey. Subjects must avoid non steroidal anti inflammatory medications for 2 weeks before the study and 2 weeks after the study.
Subjects will see their referring physician two weeks after treatment to begin physical therapy.
| Study group | Role | What they receive |
|---|---|---|
| Tenotomy Group | Active comparator | Subject enrolled in this arm will receive treatment for tendinitis and pain evaluation of pain pre and post treatment. Receives: Procedure: Tenotomy (no injection) |
| Plasma Injection Group | Active comparator | Treatment is Ultrasound guided platelet rich plasma injection. Receives: Drug: Ultrasound guided platelet rich plasma injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Level and Interference With Activity
Patient symptoms are measured on a 50 point scale where 0 is no pain or interference with activities and 50 is highest pain and interference.
A verbal evaluation and assessment of subject's pain and symptoms will be completed prior to treatment. After receiving medication a second evaluation will be taken to determine how well the medication has relieved and controlled the subject's pain and inflammation associated with tendinitis.
Subjects will be specifically asked to rate the level of pain and how the pain is affecting common activities of daily living. The outcomes will be assessed at 2 follow up periods, 1 and approximately 2 weeks after treatment (but no more than 23 days).
Measured: Up to 23 days
Secondary outcomes (1)
Number of Participants Showing Symptomatic Improvement as Assessed in Patient Chart
Information from patient charts were retrospectively reviewed to determine if symptoms were reported as improved, worse, or no change over a time period (range 15 to 555 days post treatment).
Measured: 15 to 555 days post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2012 (estimated)
- Study startJul 2010
- Primary completionJul 2015
- Study completionJul 2015
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 TendinosisStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jon Jacobson, University of Michigan
- Investigators
- Jon Jacobson, MD, Principal investigator, University of Michigan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01600326
- Sponsor's protocol ID
- HUM00039445
- Status last verified
- Feb 2017
- First submitted
- 1 May 2012
- Last updated
- 5 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Comparison of Ultrasound-Guided Percutaneous Platelet-Rich Plasma Injection Versus Tenotomy for Treatment of Gluteus Minimus and Medius Tendinosis
- ClinicalTrials.gov ID
- NCT01600326
- Acronym / sponsor ID
- HUM00039445
- Conditions
- Tendinosis, Tendinitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Jul 2010 (actual)
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 17 May 2012 (estimated)
- Results
- Posted 5 Apr 2017
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 study is to determine the effectiveness of various treatment soft tendinosis also known as tendinitis.
Detailed description
Currently there are three treatments that are considered standard of care; rest, tenotomy and tenotomy with injections of platelet-rich plasma (PRP). Tenotomy is performed by passing a needle through the abnormal tendon repeatedly until the needle has passed through all areas of the abnormal tendon with softening of the tendon. Tenotomy with PRP injections is performed in the same manner but includes an injection of platelet-rich plasma (PRP) into the tendon. This study will evaluate the effectiveness of tenotomy versus PRP treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tenotomy Group | Active comparator | Procedure: Tenotomy (no injection)Subject enrolled in this arm will receive treatment for tendinitis and pain evaluation of pain pre and post treatment. |
| Plasma Injection Group | Active comparator | Drug: Ultrasound guided platelet rich plasma injectionTreatment is Ultrasound guided platelet rich plasma injection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult subjects with a diagnosis of tendinosis of the hip.
- Adult subjects who have been referred to Dr. Jacobson for the treatment of tendinosis by tenotomy.
Key exclusion criteria (4 listed)
- pregnancy
- risk of bleeding due to anticoagulant medication
- presence of malignancy
- steroid injection less than 3 months before enrollment
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 |
|---|---|---|
| Tenotomy (no injection)Subjects randomized to this group will fill out a pre-treatment pain survey and have a blood draw They will be be contacted by the investigator by telephone or email on day 7 and day 14 to complete another pain survey. Subjects must avoid non steroidal anti-inflammatory medications for 2 weeks before the study. Two weeks after enrollment subjects see their referring physician to begin physical therapy. | Procedure or surgery | Tenotomy Group |
| Ultrasound guided platelet rich plasma injectionSubjects will fill out a pre-treatment pain survey, then will undergo ultrasound and have blood drawn from their arm. The blood sample will be separated into blood cells and plasma. The plasma portion of the blood (liquid minus the cells) will be injected into the tendon under sterile conditions. Ultrasound will help guide the injection. This is called "Ultrasound guided platelet rich plasma injection." Subjects will be be contacted by the investigator by telephone or email on day 7 and day 14 to complete another pain survey. Subjects must avoid non steroidal anti inflammatory medications for 2 weeks before the study and 2 weeks after the study. Subjects will see their referring physician two weeks after treatment to begin physical therapy. | Drug | Plasma Injection Group |
Primary outcome
Pain Level and Interference With Activity
Time frame: Up to 23 days
Patient symptoms are measured on a 50 point scale where 0 is no pain or interference with activities and 50 is highest pain and interference. A verbal evaluation and assessment of subject's pain and symptoms will be completed prior to treatment. After receiving medication a second evaluation will be taken to determine how well the medication has relieved and controlled the subject's pain and inflammation associated with tendinitis. Subjects will be specifically asked to rate the level of pain and how the pain is affecting common activities of daily living. The outcomes will be assessed at 2 follow up periods, 1 and approximately 2 weeks after treatment (but no more than 23 days).
1 secondary outcome
Number of Participants Showing Symptomatic Improvement as Assessed in Patient Chart
Time frame: 15 to 555 days post treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Jon Jacobson, MD principal investigator
University of Michigan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tenotomy (no injection) and Ultrasound guided platelet rich plasma injection in people with Tendinosis and Tendinitis, run by University of Michigan 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 2 inclusion and 4 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 5 Apr 2017. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Apr 2017). 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 Level and Interference With Activity (time frame: Up to 23 days). 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 5 Apr 2017.