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Platelet-Rich Plasma Therapy for Patellar Tendinopathy

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 39 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Age between 18 and 39 years. 2. Chronic (>3 months) PT. 3. Clinical examination consistent with PT. 4. MRI or US confirmation of PT. 5. Pain score of 3 or greater on a 10-point visual analogue scale. 6. Self-report failure of supervised physical therapy. 7. Self-report failure of at least 2 of the most common treatment options for PT (e.g. NSAIDs, relative rest, ice and bracing).

Exclusion Criteria:

1. Inability to comply with study follow-up requirements. 2. History of bleeding disorders or other hematologic conditions. 3. Knee pain from other possible etiologies (e.g., degenerative joint disease, meniscal tear, ligament injury or reconstruction) 4. Full or partial patellar tendon tear. 5. Current use of anticoagulation or immunosuppressive therapy. 6. Prior knee trauma requiring medical attention or surgery. 7. Worker's compensation injury. 8. Daily opioid use for pain. 9. Contraindication to MRI. 10. Systemic diseases such as Diabetes and connective tissue diseases. 11. Prior PRP or DN procedure. 12. Women that are pregnant

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT03136965
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 University of Wisconsin, Madison
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Kenneth Lee, MD
Principal Investigator Affiliation University of Wisconsin, Madison
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Patellar Tendinitis
Additional Details

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.

Arms & Interventions

Arms

Experimental: Platelet-Rich Plasma (PRP)

Group 1 (PRP) will receive a single US-guided injection of 5 mL autologous PRP.

Placebo Comparator: Dry Needling Procedure

Group 2 (dry needling) will undergo US-guided dry needling procedure similar to PRP injection.

Sham Comparator: Sham Procedure

Group 3 (sham) will undergo US-guided sham dry needling procedure.

Interventions

Biological: - PRP

Injection of autologous platelet rich plasma (PRP)

Procedure: - Dry Needling

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.

Procedure: - Dry Needling - Sham

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Wisconsin, Madison, Madison, Wisconsin

Status

Recruiting

Address

University of Wisconsin, Madison

Madison, Wisconsin, 53705

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