Cryoneurolysis Versus Radiofrequency in Knee Osteoarthritis

Cryoneurolysis Versus Radiofrequency in Knee Osteoarthritis: A Randomised Controlled Trial

The project will evaluate the effectiveness of Cryoneurolysis versus radiofrequency procedures in adult patients who are resistant to traditional treatment for knee pain. They are a drug-free pain management procedure.

Study Overview

• Status: Recruiting
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Device: Cryoneurolysis; Device: pulsed radiofrequency (RF); Device: cooled radiofrequency

Detailed Description

The main approach to OA management is pain control. Cryoneurolysis versus radiofrequency in decreasing knee pain.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aliaa Mamdouh Abdelaziz Farag, MD; Phone Number: +201069468486; Email: aliaa.mamdouh@med.tanta.edu.eg

Study Locations

• Egypt
  • Tanta, Egypt
    • Recruiting
    • faculty of medicine, Tanta University
    • Contact: Aliaa Mamdouh Abdelaziz Farag, MD; Phone Number: +201069468486; Email: aliaa.mamdouh@med.tanta.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Adults with a clinical diagnosis of refractory knee OA who suffered from refractory knee pain (patients who had failed conservative medical and physical therapy for 6 months .

Exclusion Criteria:

1. Patients with OA show improvement in pain after conservative medical and physical therapy.
2. Patients evaluated by an orthopedic surgeon and deemed to be surgical candidates due to knee pathologies other than OA.
3. Patients with allergies to local anesthetics.
4. patients on anticoagulation therapy, who were not permitted to stop anticoagulation.
5. Patients with knee tumors.
6. Patients with acute infections.
7. Patients with implanted cardiac devices.
8. Pregnant patients.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group I will be treated with Cryoneurolysis; Cryoneurolysis freezes nerves	Device: Cryoneurolysis; Cryoneurolysis freezes nerves
Experimental: Group II will be treated with pulsed radiofrequency (RF); radiofrequency (RF) uses electric pulses	Device: pulsed radiofrequency (RF); radiofrequency (RF) uses electric pulses
Experimental: Group III will be treated with cooled radiofrequency (RF); uses cooled radiofrequency energy to deactivate pain-causing nerves	Device: cooled radiofrequency; uses cooled radiofrequency energy to deactivate pain-causing nerves

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in visual analogue scale after intervention	Decrement (clinical improvement) in visual analogue scale (VAS) immediately after intervention. The participant's knee discomfort was measured using a VAS. Participants were asked to score their level of pain on a 100-mm horizontal line, ranging from 0 to 100.	immediately after intervention

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: June 16, 2026
• First Submitted That Met QC Criteria: June 17, 2026
• First Posted (Actual): June 24, 2026

Study Record Updates

• Last Update Posted (Actual): August 11, 2026
• Last Update Submitted That Met QC Criteria: August 9, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee; Therapeutics; Physical Therapy Modalities; Rehabilitation; Electric Stimulation Therapy; Radiofrequency Therapy; Pulsed Radiofrequency Treatment
• Other Study ID Numbers: 36265PR83/5/26

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Plan to Share IPD: "Yes" Plan Description: "Data obtained through this study may be provided to qualified researchers with academic interest in scapular dyskinesis. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e., a material transfer agreement) are prerequisites to the sharing of data with the requesting party.

Results will be published by the investigators in academic journal.

• IPD Sharing Time Frame: Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis
• IPD Sharing Access Criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No