Platelet-Rich Plasma Therapy for Patellar Tendinopathy (PRP)

University of Wisconsin (UW)

Status and phase: Completed; Phase 2

Conditions: Patellar Tendinitis

Treatments: Biological: PRP; Procedure: Dry Needling; Procedure: Dry Needling - Sham

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03136965

2016-0811

SMPH/RADIOLOGY/RADIOLOGY* (Other Identifier)

A539300 (Other Identifier)

Protocol Ver 0.15, 12/23/2021 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 39 years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 3 patient groups, including a placebo group

Platelet-Rich Plasma (PRP)

Experimental group

Description:

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

Treatment:

Biological: PRP

Dry Needling Procedure

Placebo Comparator group

Description:

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

Treatment:

Procedure: Dry Needling

Sham Procedure

Sham Comparator group

Description:

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

Treatment:

Procedure: Dry Needling - Sham