TendinopathyNCT01406821
Treatment of Acute and Chronic Ligament and Tendon Injuries With Platelet Rich Plasma
A study testing Ultrasound-guided platelet-rich-plasma (PRP) injection and Ultrasound-guided dry needling in people with Tendinopathy, run by Stanford University at 2 sites in United States.
Trial summary
Platelet rich plasma has been used in previous studies to stimulate faster healing of torn ligaments and tendons in order to help reduce pain and restore normal function. This study aims to prove that non-operative treatment of acute and chronic ligament and tendon injuries with platelet rich plasma will reduce the… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tendinopathy
- What is being tested?
- Ultrasound-guided platelet-rich-plasma (PRP) injection and Ultrasound-guided dry needling
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2009to 15 Mar 2019
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -Acute or chronic ligament or tendon injuries
Who cannot join
- Pregnant women,
- children,
- other injuries that require surgical intervention,
- associated fractures,
- systemic disease resulting in an immunocompromised state affecting ability to heal soft tissues
Trial locations and contacts
2 sites in 1 country.
United States2 sites
New York University Langone Orthopedic Hospital
New York, New York, 10003
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: Randomized, Double-blind Clinical Trial of Platelet Rich Plasma for Treatment of Acute and Chronic Patellar Tendinosis
Platelet rich plasma has been used in previous studies to stimulate faster healing of torn ligaments and tendons in order to help reduce pain and restore normal function. This study aims to prove that non-operative treatment of acute and chronic ligament and tendon injuries with platelet rich plasma will reduce the time needed for participants to heal these injuries and restore function.
We are currently enrolling patients with PATELLAR TENDON INJURIES in the KNEE.
Read the detailed description
Pre-procedure diagnosis: The appropriate clinical evaluation will be dictated by the examining physician. Minimal pre-procedure studies will include plain radiographs and MRI. All patients will complete a pretreatment questionnaire.
Patients will be randomized and blinded to a treatment regimen.
Method of randomization: Some of the participating subjects will receive platelet rich plasma and others will receive a saline injection. The platelet rich plasma experimental group will have up to 50cc of whole blood collected via venipuncture and prepared using the standard PRP protocol.
To blind the control group these patients will have a simulated needle stick and approximately 10 ml (2 teaspoons) of blood will be drawn. No blood will be given back to the patient. For those in the control group their ligament or tendon will be stimulated with dry needling (moving a needle up and down in the tendon, without injection). Patients in the PRP treatment group will also have dry needling, plus the PRP will be injected into the tendon as well.
Platelet rich plasma injections have an equivalent risk profile to routine injections. Those potential risks include skin discoloration, pain at injection site, superficial or deep infection, no relief of symptoms, worsening of symptoms, and damage to nerve and blood vessels. Potential benefits include significant improvement in symptoms and reduction in time for return to function.
Post injection activity: All patients will use crutches for 24-48 hours after injection. All patients will have physical therapy two times a week according to a standardized protocol.
Follow up at the clinic for all patients will be every 3 weeks from weeks 1-12. All patients will fill out an injury location specific questionnaire, Tegner Activity Scale, short form-12, and visual analog scale for pain, among others. Additional follow-up will be done at 6 months, 1 year and 2 years. All radiographic studies will be read by a radiologist blinded to the study groups.
The primary endpoint for all patients in the study will be twelve weeks. Secondary enpoints are 6 months, 1 year and 2 years.
- Conditions
- Tendinopathy
- Being tested
- Ultrasound-guided platelet-rich-plasma (PRP) injection, Ultrasound-guided dry needling
- Keywords
- PRP, platelet-rich-plasma, platelet, tendinosis, tendinitis, tendonitis, tendinopathy, enthesopathy, muscle, sport, tendon, patella, patellar tendon
- Medical subject headings
- Tendinopathy, Enthesopathy, Patella Fracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided platelet-rich-plasma (PRP) injectionProcedure or surgery
Blood will be drawn, and platelet-rich plasma will be injected into the tendon under ultrasound guidance.
Ultrasound-guided dry needlingProcedure or surgery
Blood will be drawn, and tendon will be penetrated with dry needle under ultrasound guidance. Nothing will be injected into the tendon.
| Study group | Role | What they receive |
|---|---|---|
| Dry needling | Sham comparator | Blood will be drawn, and tendon will be penetrated with dry needle. Nothing will be injected into the tendon. Receives: Procedure: Ultrasound-guided dry needling |
| Platelet-rich plasma (PRP) | Experimental | Blood will be drawn, and platelet-rich plasma will be injected into the tendon. Receives: Procedure: Ultrasound-guided platelet-rich-plasma (PRP) injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-reported improvement in symptoms at 12 weeks
Measured: 12 weeks
Secondary outcomes (1)
Reduction in patellar tendinosis by MRI
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2011 (estimated)
- Study startAug 2009
- Primary completion15 Mar 2019
- Study completion15 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TendinopathyStudies of the same condition, open and under way.
- More trials run by Stanford 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, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- NYU Langone Health
- Responsible party
- Principal investigator, Jason L. Dragoo, Stanford University
- Investigators
- Dr. Christina Herrero, Study director, New York University Langone Orthopedic HospitalDr. Jason L. Dragoo, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01406821
- Sponsor's protocol ID
- SU-10162010-7109
- Other IDs
- 16595
- Status last verified
- Mar 2019
- First submitted
- 28 Jul 2011
- Last updated
- 29 Mar 2019
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind Clinical Trial of Platelet Rich Plasma for Treatment of Acute and Chronic Patellar Tendinosis
- ClinicalTrials.gov ID
- NCT01406821
- Acronym / sponsor ID
- SU-10162010-7109
- Conditions
- Tendinopathy
- Keywords
- PRP, platelet-rich-plasma, platelet, tendinosis, tendinitis, tendonitis, tendinopathy, enthesopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- NYU Langone Health
- Study start
- Aug 2009 (actual)
- Primary completion
- 15 Mar 2019 (actual)
- Study completion
- 15 Mar 2019 (actual)
- First posted
- 1 Aug 2011 (estimated)
- 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.
Platelet rich plasma has been used in previous studies to stimulate faster healing of torn ligaments and tendons in order to help reduce pain and restore normal function. This study aims to prove that non-operative treatment of acute and chronic ligament and tendon injuries with platelet rich plasma will reduce the time needed for participants to heal these injuries and restore function.
We are currently enrolling patients with PATELLAR TENDON INJURIES in the KNEE.
Detailed description
Pre-procedure diagnosis: The appropriate clinical evaluation will be dictated by the examining physician. Minimal pre-procedure studies will include plain radiographs and MRI. All patients will complete a pretreatment questionnaire.
Patients will be randomized and blinded to a treatment regimen.
Method of randomization: Some of the participating subjects will receive platelet rich plasma and others will receive a saline injection. The platelet rich plasma experimental group will have up to 50cc of whole blood collected via venipuncture and prepared using the standard PRP protocol.
To blind the control group these patients will have a simulated needle stick and approximately 10 ml (2 teaspoons) of blood will be drawn. No blood will be given back to the patient. For those in the control group their ligament or tendon will be stimulated with dry needling (moving a needle up and down in the tendon, without injection). Patients in the PRP treatment group will also have dry needling, plus the PRP will be injected into the tendon as well.
Platelet rich plasma injections have an equivalent risk profile to routine injections. Those potential risks include skin discoloration, pain at injection site, superficial or deep infection, no relief of symptoms, worsening of symptoms, and damage to nerve and blood vessels. Potential benefits include significant improvement in symptoms and reduction in time for return to function.
Post injection activity: All patients will use crutches for 24-48 hours after injection. All patients will have physical therapy two times a week according to a standardized protocol.
Follow up at the clinic for all patients will be every 3 weeks from weeks 1-12. All patients will fill out an injury location specific questionnaire, Tegner Activity Scale, short form-12, and visual analog scale for pain, among others. Additional follow-up will be done at 6 months, 1 year and 2 years. All radiographic studies will be read by a radiologist blinded to the study groups.
The primary endpoint for all patients in the study will be twelve weeks. Secondary enpoints are 6 months, 1 year and 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dry needling | Sham comparator | Procedure: Ultrasound-guided dry needlingBlood will be drawn, and tendon will be penetrated with dry needle. Nothing will be injected into the tendon. |
| Platelet-rich plasma (PRP) | Experimental | Procedure: Ultrasound-guided platelet-rich-plasma (PRP) injectionBlood will be drawn, and platelet-rich plasma will be injected into the tendon. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Acute or chronic ligament or tendon injuries
Key exclusion criteria (5 listed)
- Pregnant women,
- children,
- other injuries that require surgical intervention,
- associated fractures,
- systemic disease resulting in an immunocompromised state affecting ability to heal soft tissues
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 |
|---|---|---|
| Ultrasound-guided platelet-rich-plasma (PRP) injectionBlood will be drawn, and platelet-rich plasma will be injected into the tendon under ultrasound guidance. | Procedure or surgery | Platelet-rich plasma (PRP) |
| Ultrasound-guided dry needlingBlood will be drawn, and tendon will be penetrated with dry needle under ultrasound guidance. Nothing will be injected into the tendon. | Procedure or surgery | Dry needling |
Primary outcome
Patient-reported improvement in symptoms at 12 weeks
Time frame: 12 weeks
1 secondary outcome
Reduction in patellar tendinosis by MRI
Time frame: 6 months
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 29 Mar 2019.
- 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.
Dr. Christina Herrero study director
New York University Langone Orthopedic Hospital
Dr. Jason L. Dragoo principal investigator
Stanford University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-guided platelet-rich-plasma (PRP) injection and Ultrasound-guided dry needling in people with Tendinopathy, run by Stanford University at 2 sites 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 1 inclusion and 5 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 29 Mar 2019. 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 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. Some participants in this study may receive a placebo. 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?
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?
Patient-reported improvement in symptoms at 12 weeks (time frame: 12 weeks). 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 29 Mar 2019.