Comparison of Conventional and Cooled Radiofrequency Ablation in Knee Osteoarthritis

NCT06863181 | Completed

• 1 other identifier: AEŞH-EK-2025-064
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to examine and compare the effects of conventional and cooled radiofrequency ablation on pain and disability levels in patients with knee pain resistant to other treatments due to knee osteoarthritis.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale (VAS)

  Patients will select their pain from 10 mm scale

  Before treatment (0. week), 4 weeks after treatment (4.week), 12 weeks after treatment (12.week)

Secondary Outcomes (3)

• Western Ontario and McMaster Universities Arthritis Index (WOMAC)

  Before treatment (0. week), 4 weeks after treatment (4.week), 12 weeks after treatment (12.week)

• 5-Point Likert Patient Satisfaction Scale

  Before treatment (0. week), 4 weeks after treatment (4.week), 12 weeks after treatment (12.week)

• Change in frequency of analgesic use

  Before treatment (0. week), 4 weeks after treatment (4.week), 12 weeks after treatment (12.week)

Study Arms (2)

Conventional Radiofrequency Ablation

ACTIVE COMPARATOR

Conventional radiofrequency ablation with fluoroscopy

Device: Radiofrequency ablation

Cooled Radiofrequency Ablation

EXPERIMENTAL

Cooled radiofrequency ablation with ultrasound

Device: Radiofrequency ablation

Interventions

Radiofrequency ablation DEVICE

Genicular nerve neurolysis with heat

Conventional Radiofrequency Ablation; Cooled Radiofrequency Ablation

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Knee pain lasting more than 6 months
• Age between 50 and 80
• Diagnosis of radiographically proven grade III or IV knee osteoarthritis according to the Kellgren-Lawrence Grading Scale, marked narrowing of the medial compartment of the tibiofemoral joint space
• Presence of pain resistant to conservative treatment
• Exercise
• Physical therapy agents
• Use of oral anti-inflammatory agents

You may not qualify if:

• History of trauma to the knee area
• History of knee surgery
• Presence of systemic inflammatory disease affecting the knee joint
• Presence of peripheral neuropathy or radiculopathy
• Pregnancy
• Hemodynamic instability
• Presence of skin or soft tissue infection at the injection site
• Refusal to participate in the study
• Presence of acute knee pain with accompanying inflammatory findings
• Presence of a serious psychiatric disorder or neurological disease Having received an intra-articular injection within the last 3 months

Sponsors & Collaborators

• Gaziler Physical Medicine and Rehabilitation Education and Research Hospital: lead

Study Sites (1)

Gaziler Physical Medicine and Rehabilitation Training and Research Hospital

Ankara, Çankaya, 06800, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: specialist

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 7, 2025
• Study Start: February 1, 2025
• Primary Completion: August 12, 2025
• Study Completion: November 12, 2025
• Last Updated: February 27, 2026

Record last verified: 2025-03

Locations

TU (1)