MedTrace Logo

Leukocyte-Poor Platelet-Rich Plasma Reduces Pain Symptoms in the Treatment of the Lateral Epicondylitis

NCT06854666 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2025-03-03

No results posted yet for this study

Summary

Lateral epicondylar tendinopathy (LET), or tennis elbow, is a degenerative condition affecting the forearm's extensor tendons. It commonly leads to pain, reduced grip strength, and impaired function, particularly in individuals performing repetitive wrist and forearm movements. Standard treatments, including physiotherapy, braces, and anti-inflammatory medications, provide relief but do not always lead to full recovery. Platelet-rich plasma (PRP) has gained interest as a regenerative therapy with the potential to enhance tendon healing and improve clinical outcomes.

This randomized, double-blind, placebo-controlled trial aims to evaluate PRP's effectiveness in treating LET, comparing it to leukocyte-rich PRP (L-PRP) and saline (placebo). Additionally, it assesses the composition of PRP and its role in tendon regeneration.

The study will enroll 80 patients diagnosed with LET, meeting predefined clinical criteria. Participants will be randomized into three groups (PRP, L-PRP, saline) and receive two injections (day 0 and day 7). PRP will be prepared using a standardized protocol to ensure consistency.

Patients will undergo clinical evaluations (VAS, Mayo Elbow Score, SECEC Elbow Score), grip strength testing, and MRI scans at baseline and 24 weeks post-treatment. The PRP composition will be analyzed in a laboratory. Follow-ups will be conducted at 12, 24, and 54 weeks to monitor pain reduction, functional improvement, and tendon healing.

This study will provide critical insights into PRP's therapeutic potential, helping refine treatment approaches for LET and improve patient outcomes.

Conditions

  • Tennis Elbow
  • Lateral Epicondylitis
  • Lateral Epicondylitis (tennis Elbow)
  • PRP Injection
  • PRP and Physiotherapy

Interventions

OTHER

effectiveness of platelet-rich plasma (PRP) in treating lateral epicondylar tendinopathy (LET)

The intervention involves the administration of PRP (platelet-rich plasma), L-PRP (leukocyte-rich platelet-rich plasma), and saline according to a protocol developed for patients with lateral epicondylitis (EPi lat). The intervention includes specific parameters such as centrifugation speed and dual injection to the painful site, which is repeated after one week. Following the procedure, treatment continues with a rehabilitation program, including the use of an orthosis. The orthosis serves as support during the recovery process after the injection. The rehabilitation program and the use of the orthosis aim to improve joint function and reduce pain, supporting tissue healing and regeneration.

Sponsors & Collaborators

  • Rehasport Clinic

    lead OTHER

Principal Investigators

  • Joanna Walecka, MD, PhD · Rehasport Clinic

  • Przemyslaw Lubiatowski, MD, Phd, · Rehasport Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-02
Primary Completion
2024-02-10
Completion
2024-03-10

Countries

  • Poland

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06854666 on ClinicalTrials.gov