Patellar TendinitisPhase 2PRPNCT03136965
Platelet-Rich Plasma Therapy for Patellar Tendinopathy
A Phase 2 study testing PRP and Dry Needling in people with Patellar Tendinitis, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The overall goal of this research is to find an effective treatment for patellar tendinopathy (PT). To achieve this, we will conduct a double-blinded randomized controlled trial to investigate if platelet-rich plasma is effective for treatment. Read more about this study
- Who is it for?
- Ages 18 to 39 years
- Conditions the study is for
- Patellar Tendinitis
- What is being tested?
- PRP and 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
- 1 siteUnited States
- Study dates
- 25 Apr 2017to 15 Aug 2022
- 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 to 39 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18 and 39 years
- Chronic (>3 months) PT
- Clinical examination consistent with PT
- MRI or US confirmation of PT
- Pain score of 3 or greater on a 10-point visual analogue scale
- Self-report failure of supervised physical therapy
- Self-report failure of at least 2 of the most common treatment options for PT (e.g. NSAIDs, relative rest, ice and bracing).
Who cannot join
- Inability to comply with study follow-up requirements
- History of bleeding disorders or other hematologic conditions
- Knee pain from other possible etiologies (e.g., degenerative joint disease, meniscal tear, ligament injury or reconstruction)
- Full or partial patellar tendon tear
- Current use of anticoagulation or immunosuppressive therapy
- Prior knee trauma requiring medical attention or surgery
Show all 12Show fewer
- Worker's compensation injury
- Daily opioid use for pain
- Contraindication to MRI.
- Systemic diseases such as Diabetes and connective tissue diseases.
- Prior PRP or DN procedure.
- Women that are pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin, Madison
Madison, Wisconsin, 53705
About this study
Official title: Platelet-Rich Plasma (PRP) Therapy for Patellar Tendinopathy: A Randomized Controlled Trial Correlating Clinical, Biomechanical and Novel Imaging Biomarkers
The overall goal of this research is to find an effective treatment for patellar tendinopathy (PT). To achieve this, we will conduct a double-blinded randomized controlled trial to investigate if platelet-rich plasma is effective for treatment. Clinical (pain and function scores) and bio-mechanical (knee strength) measures will be correlated with disease modification changes assessed using conventional and novel quantitative magnetic resonance imaging (MRI) and ultrasound (US) techniques.
Read the detailed description
Sixty-six patients with PT will be randomized to one of three study arms. Subjects in Group 1 (PRP) will receive a single US-guided injection of 5 milliliters of autologous PRP into the patellar tendon, subjects in Group 2 (DN) will undergo ultrasound guided dry needling of the patellar tendon, and subjects in Group 3 (SH) will undergo a sham control ultrasound guided dry needling in the subcutaneous tissue only (not intratendon) at the level of the patellar tendon. The efficacy of the different treatment options will be assessed by pain- and function-dependent, PT-specific Victorian Institute of Sport Assessment Patella (VISA-P) quality of life scores, activity level scores, knee strength measurements, and conventional and novel MRI and US imaging at baseline, 16, 32, and 52 weeks post-treatment.
- Conditions
- Patellar Tendinitis
- Being tested
- PRP, Dry Needling, Dry Needling - Sham
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRPBiological
Injection of autologous platelet rich plasma (PRP)
Dry NeedlingProcedure or surgery
This is a therapeutic procedure that involves the same injection procedures under ultrasound guidance as in the PRP group but no PRP will be injected inside the patellar tendon.
Dry Needling - ShamProcedure or surgery
This is a sham procedure that involves similar injection procedures under ultrasound guidance as in the PRP and DN groups with no injection of PRP or needle placement inside the patellar tendon.
| Study group | Role | What they receive |
|---|---|---|
| Platelet-Rich Plasma (PRP) | Experimental | Group 1 (PRP) will receive a single US-guided injection of 5 mL autologous PRP. Receives: Biological: PRP |
| Dry Needling Procedure | Placebo comparator | Group 2 (dry needling) will undergo US-guided dry needling procedure similar to PRP injection. Receives: Procedure: Dry Needling |
| Sham Procedure | Sham comparator | Group 3 (sham) will undergo US-guided sham dry needling procedure. Receives: Procedure: Dry Needling - Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Measure of Pain Level: VISA-P Score
A quality of life measure, the Victoria Institute of Sport Assessment - Patellar Tendon (VISA-P) will be used to evaluate pain before and after the intervention. The instrument is scored from 0-100 with higher scores indicating less pain.
Measured: baseline, 16 weeks, 32 weeks, 52 weeks
Change in Measure of Activity Level: Tegner Activity Level Score
The Tegner Activity Level Score will be used to evaluate activity level before and after the intervention. It is scored from 0-10 with 0 indicating disability and 10 competitive elite sport.
Measured: baseline, 16 weeks, 32 weeks, 52 weeks
Change in Visual Analogue Scale (VAS) Pain Score
Participant pain level was assessed using a VAS score from 0 (no pain) to 10 (worst pain).
Measured: baseline, 16 weeks, 32 weeks, 52 weeks
Secondary outcomes (5)
MRI Scan To Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (T2 Signal Intensity)
To demonstrate treatment-related changes in pathologic imaging features of PT using conventional MRI measures.
Measured: baseline, 16 weeks, 52 weeks
MRI Scan To Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Thickness)
To demonstrate treatment-related changes in pathologic imaging features of PT using conventional MRI measures.
Measured: baseline, 16 weeks, 52 weeks
Ultrasound Scan to Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Thickness)
To demonstrate treatment-related changes in pathologic imaging features of PT using conventional ultrasound measures.
Measured: baseline, 16 weeks, 52 weeks
Ultrasound Scan to Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Echogenicity) From Baseline
To demonstrate treatment-related changes in pathologic imaging features of PT using conventional ultrasound measures. Echogenicity is the grey scale images found on standard B-mode exams. The grey scale can change with pathology, therefore, the grading scale is implemented. The data reported are scores from a grading system, where 0 - normal; 1- mild; 2- moderate; 3- severe.
Measured: baseline, 16 weeks, 52 weeks
Ultrasound Scan to Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Hyperemia) From Baseline
To demonstrate treatment-related changes in pathologic imaging features of PT using conventional ultrasound measures. Hyperemia means an increase in the number of blood vessels, it is scored on a semi-qualitative scale where 0 - normal; 1- mild; 2- moderate; 3- severe. If there's an improvement in hyperemia grading then the score decreases.
Measured: baseline, 16 weeks, 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2017
- Study start25 Apr 2017
- Primary completion15 Aug 2022
- Study completion15 Aug 2022
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 Patellar TendinitisStudies of the same condition, open and under way.
- 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
- Model description
- Double-blinded randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- General Electric
- Responsible party
- Sponsor
- Investigators
- Kenneth Lee, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03136965
- Sponsor's protocol ID
- 2016-0811
- Other IDs
- A539300, SMPH/RADIOLOGY/RADIOLOGY*, Protocol Ver 0.15, 12/23/2021
- Acronym
- PRP
- Status last verified
- Oct 2023
- First submitted
- 6 Apr 2017
- Last updated
- 26 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- 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 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet-Rich Plasma (PRP) Therapy for Patellar Tendinopathy: A Randomized Controlled Trial Correlating Clinical, Biomechanical and Novel Imaging Biomarkers
- ClinicalTrials.gov ID
- NCT03136965
- Acronym / sponsor ID
- PRP / 2016-0811
- Conditions
- Patellar Tendinitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- General Electric
- Study start
- 25 Apr 2017 (actual)
- Primary completion
- 15 Aug 2022 (actual)
- Study completion
- 15 Aug 2022 (actual)
- First posted
- 2 May 2017 (actual)
- Results
- Posted 26 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall goal of this research is to find an effective treatment for patellar tendinopathy (PT). To achieve this, we will conduct a double-blinded randomized controlled trial to investigate if platelet-rich plasma is effective for treatment. Clinical (pain and function scores) and bio-mechanical (knee strength) measures will be correlated with disease modification changes assessed using conventional and novel quantitative magnetic resonance imaging (MRI) and ultrasound (US) techniques.
Detailed description
Sixty-six patients with PT will be randomized to one of three study arms. Subjects in Group 1 (PRP) will receive a single US-guided injection of 5 milliliters of autologous PRP into the patellar tendon, subjects in Group 2 (DN) will undergo ultrasound guided dry needling of the patellar tendon, and subjects in Group 3 (SH) will undergo a sham control ultrasound guided dry needling in the subcutaneous tissue only (not intratendon) at the level of the patellar tendon. The efficacy of the different treatment options will be assessed by pain- and function-dependent, PT-specific Victorian Institute of Sport Assessment Patella (VISA-P) quality of life scores, activity level scores, knee strength measurements, and conventional and novel MRI and US imaging at baseline, 16, 32, and 52 weeks post-treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Double-blinded randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Platelet-Rich Plasma (PRP) | Experimental | Biological: PRPGroup 1 (PRP) will receive a single US-guided injection of 5 mL autologous PRP. |
| Dry Needling Procedure | Placebo comparator | Procedure: Dry NeedlingGroup 2 (dry needling) will undergo US-guided dry needling procedure similar to PRP injection. |
| Sham Procedure | Sham comparator | Procedure: Dry Needling - ShamGroup 3 (sham) will undergo US-guided sham dry needling procedure. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age between 18 and 39 years
- Chronic (>3 months) PT
- Clinical examination consistent with PT
- MRI or US confirmation of PT
- Pain score of 3 or greater on a 10-point visual analogue scale
Key exclusion criteria (12 listed)
- Inability to comply with study follow-up requirements
- History of bleeding disorders or other hematologic conditions
- Knee pain from other possible etiologies (e.g., degenerative joint disease, meniscal tear, ligament injury or reconstruction)
- Full or partial patellar tendon tear
- Current use of anticoagulation or immunosuppressive 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 |
|---|---|---|
| PRPInjection of autologous platelet rich plasma (PRP) | Biological | Platelet-Rich Plasma (PRP) |
| Dry NeedlingThis is a therapeutic procedure that involves the same injection procedures under ultrasound guidance as in the PRP group but no PRP will be injected inside the patellar tendon. | Procedure or surgery | Dry Needling Procedure |
| Dry Needling - ShamThis is a sham procedure that involves similar injection procedures under ultrasound guidance as in the PRP and DN groups with no injection of PRP or needle placement inside the patellar tendon. | Procedure or surgery | Sham Procedure |
Primary outcome
Change in Measure of Pain Level: VISA-P Score
Time frame: baseline, 16 weeks, 32 weeks, 52 weeks
A quality of life measure, the Victoria Institute of Sport Assessment - Patellar Tendon (VISA-P) will be used to evaluate pain before and after the intervention. The instrument is scored from 0-100 with higher scores indicating less pain.
Change in Measure of Activity Level: Tegner Activity Level Score
Time frame: baseline, 16 weeks, 32 weeks, 52 weeks
The Tegner Activity Level Score will be used to evaluate activity level before and after the intervention. It is scored from 0-10 with 0 indicating disability and 10 competitive elite sport.
Change in Visual Analogue Scale (VAS) Pain Score
Time frame: baseline, 16 weeks, 32 weeks, 52 weeks
Participant pain level was assessed using a VAS score from 0 (no pain) to 10 (worst pain).
5 secondary outcomes
MRI Scan To Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (T2 Signal Intensity)
Time frame: baseline, 16 weeks, 52 weeks
MRI Scan To Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Thickness)
Time frame: baseline, 16 weeks, 52 weeks
Ultrasound Scan to Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Thickness)
Time frame: baseline, 16 weeks, 52 weeks
Ultrasound Scan to Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Echogenicity) From Baseline
Time frame: baseline, 16 weeks, 52 weeks
Ultrasound Scan to Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Hyperemia) From Baseline
Time frame: baseline, 16 weeks, 52 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Patellar Tendinitis
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Patellar Tendinitis, Jumper's Knee
Recruiting
Clinical Eficacy of Extracorporeal Shock Wave Therapy on Patellar Tendinitis
Shock Wave Threapy for Patellar Tendinitis
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.
Kenneth Lee, MD principal investigator
University of Wisconsin, Madison
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 PRP and Dry Needling in people with Patellar Tendinitis, run by University of Wisconsin, Madison 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 7 inclusion and 12 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 26 Oct 2023. 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. 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.
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 26 Oct 2023). 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?
Change in Measure of Pain Level: VISA-P Score (time frame: baseline, 16 weeks, 32 weeks, 52 weeks). 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?
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 26 Oct 2023.