NCT07351981

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
1mo left

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress83%
Jan 2026Jun 2026

First Submitted

Initial submission to the registry

January 10, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

January 15, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 20, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

January 20, 2026

Status Verified

January 1, 2026

Enrollment Period

2 months

First QC Date

January 10, 2026

Last Update Submit

January 10, 2026

Conditions

Knee OAKnee Osteoarthristis

Keywords

kneeosteoarthritis

Outcome Measures

Primary Outcomes (1)

  • Pain Reduction

    Measured using the NRS (numerical rating scale) at baseline, immediately after treatment, and at follow-up intervals (2 weeks, 4 weeks, 8 weeks, 12 weeks).

    12 weeks

Secondary Outcomes (2)

  • Functional Improvement

    12 weeks

  • • Patient Satisfaction

    12 weeks

Study Arms (2)

TcPRF

ACTIVE COMPARATOR

Transcutaneous pulsed RF -connected to treatment mode of the spring pulsed rf generator

Device: Transcutaneous Pulsed Radiofrequency (PRF) Treatment for Knee Pain

TcPRF sham

SHAM COMPARATOR

sham of transcutaneus pRF- connected to demo mode of the spring pulsed rf generator

Device: sham treatment of pulsed rf on knee

Interventions

Transcutaneous Pulsed Radiofrequency (PRF) Treatment for Knee PainDEVICE

application of TcPRF patches

TcPRF
sham treatment of pulsed rf on kneeDEVICE

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

TcPRF sham

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aretaieion University Hospital

Athens, Greece

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
double blind, assessor masked
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: * 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)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assisitant Professor Of Anaesthesiology

Study Record Dates

First Submitted

January 10, 2026

First Posted

January 20, 2026

Study Start

January 15, 2026

Primary Completion

March 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

January 20, 2026

Record last verified: 2026-01

Locations

GR(1)