Platelet-Rich Plasma Therapy for Patellar Tendinopathy

NCT ID: NCT03136965

Last Updated: 2023-10-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-25
• Study Completion Date: 2022-08-15

Brief 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. 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.

Conditions

Patellar Tendinitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Platelet-Rich Plasma (PRP)

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

Group Type: EXPERIMENTAL

PRP

Intervention Type: BIOLOGICAL

Injection of autologous platelet rich plasma (PRP)

Dry Needling Procedure

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

Group Type: PLACEBO_COMPARATOR

Dry Needling

Intervention Type: PROCEDURE

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.

Sham Procedure

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

Group Type: SHAM_COMPARATOR

Dry Needling - Sham

Intervention Type: PROCEDURE

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.

Interventions

PRP

Injection of autologous platelet rich plasma (PRP)

Intervention Type: BIOLOGICAL

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

General Electric

INDUSTRY

Sponsor Role: collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kenneth Lee, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

University of Wisconsin, Madison

Madison, Wisconsin, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

A539300

Identifier Type: OTHER

Identifier Source: secondary_id

SMPH/RADIOLOGY/RADIOLOGY*

Identifier Type: OTHER

Identifier Source: secondary_id

Protocol Ver 0.15, 12/23/2021

Identifier Type: OTHER

Identifier Source: secondary_id

2016-0811

Identifier Type: -

Identifier Source: org_study_id