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TcPRF for Knee Osteoarthritis

NCT07351981 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-01-20

No results posted yet for this study

Summary

Objectives

* Primary Objective: To evaluate the efficacy of transcutaneous PRF treatment in reducing knee pain compared to a sham intervention
* Secondary Objectives: To assess the improvement in functional outcomes and patient satisfaction following PRF treatment.

Study Design

* Type: Randomized, double-blind, sham-controlled study.
* Duration: 6 months
* Study Population: Adults aged 40-75 years with chronic knee pain (lasting ≥ 6 months) due to osteoarthritis (OA).
* How many patients in each group: 25 patients in each group (according to Janssens et al, 2024) Inclusion Criteria
* Diagnosed with knee osteoarthritis according to NICE criteria.
* Chronic knee pain (Visual Analogue Scale \[VAS\] ≥ 4).
* Failure to respond adequately to conventional treatments (e.g., NSAIDs, physical therapy).
* Willingness to comply with study procedures. Exclusion Criteria
* Previous PRF/RF treatment for knee pain.
* Hyaluronic acid injection for knee pain in the past 6 months
* Knee surgery within the last 6 months.
* Severe cardiovascular, neurological, or psychiatric conditions.
* Active systemic infections or local skin infections at the knee.
* Pregnancy or lactation.

Conditions

  • Knee OA
  • Knee Osteoarthristis

Interventions

DEVICE

Transcutaneous Pulsed Radiofrequency (PRF) Treatment for Knee Pain

application of TcPRF patches

DEVICE

sham treatment of pulsed rf on knee

Transdermal patch will be connected to demo mode of the spring pulsed rf generator. no treatment will be given

Sponsors & Collaborators

  • National and Kapodistrian University of Athens

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-15
Primary Completion
2026-03-01
Completion
2026-06-01

Countries

  • Greece

Study Locations

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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 NCT07351981 on ClinicalTrials.gov