Cryoneurolysis Versus Radiofrequency in Knee Osteoarthritis

NCT07664371 | Recruiting DMC

• 1 other identifier: 36265PR83/5/26
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Group I will be treated with Cryoneurolysis

EXPERIMENTAL

Cryoneurolysis freezes nerves

Device: Cryoneurolysis

Group II will be treated with pulsed radiofrequency (RF)

EXPERIMENTAL

radiofrequency (RF) uses electric pulses

Device: pulsed radiofrequency (RF)

Group III will be treated with cooled radiofrequency (RF)

EXPERIMENTAL

uses cooled radiofrequency energy to deactivate pain-causing nerves

Device: cooled radiofrequency

Interventions

Cryoneurolysis DEVICE

Cryoneurolysis freezes nerves

Group I will be treated with Cryoneurolysis

pulsed radiofrequency (RF) DEVICE

radiofrequency (RF) uses electric pulses

Group II will be treated with pulsed radiofrequency (RF)

cooled radiofrequency DEVICE

uses cooled radiofrequency energy to deactivate pain-causing nerves

Group III will be treated with cooled radiofrequency (RF)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adults between the ages of 30 and 70 years with a clinical diagnosis of refractory knee OA who suffered from knee pain.
• Patients who cannot afford intra-articular injections.
• patients who had failed 2 different oral pain medications, and 6 weeks of physical therapy.

You may not qualify if:

• Patients with OA show improvement in pain after physiotherapy.
• patients evaluated by an orthopedic surgeon and deemed to be surgical candidates due to knee pathologies other than OA.
• pregnant patients.
• patients on anticoagulation therapy, who were not permitted to stop anticoagulation.
• patients with previous trauma, neurological or endocrine diseases like diabetes mellitus, and knee tumors; and patients with inflammatory arthritis.
• people who had received an intra-articular knee injection within the last 6 months.
• Patients with tendon tears, bursitis, or calcified tendonitis as proven by imaging.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Faculty of medicine, Tanta University

Tanta, Egypt

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Pulsed Radiofrequency Treatment

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Radiofrequency Therapy; Rehabilitation

Central Study Contacts

Aliaa Mamdouh Abdelaziz Farag, MD

CONTACT

+201069468486; aliaa.mamdouh@med.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: This is a prospective, randomised study. The closed envelop randomization method will be used for the randomization of the patients who will be also blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: June 16, 2026
• First Posted: June 24, 2026
• Study Start: June 10, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: July 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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
• 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).

Locations

EG (1)