Comparison of the Effectiveness of Conventional and Pulse Radiofrequency Therapy in Advanced Knee Osteoarthritis in Elderly Patients: An Observational Study (pain)

August 1, 2025 updated by: Halil Ibrahim Altun, Kanuni Sultan Suleyman Training and Research Hospital

Knee osteoarthritis (OA) is a very common joint disease, causing pain and loss of function. Osteoarthritis, including knee OA, is a significant cause of morbidity and disability in older adults and negatively impacts the functionality of individuals over the age of 65. When non-invasive treatments such as medical therapy, physical therapy, and rehabilitation fail to provide adequate pain control, intra-articular injections, geniculate nerve blocks, radiofrequency ablation, and surgical treatments are considered.

Genicular nerve blocks provide short-term pain relief in knee osteoarthritis . Despite various conservative treatments, many patients with chronic knee OA experience severe knee pain before total knee arthroplasty. Genicular nerve block (GNB) and radiofrequency ablation of the geniculate nerves have been shown to be effective in relieving pain and improving knee functionality in patients with chronic knee OA. Intra-articular corticosteroids are used in the treatment of knee OA to rapidly relieve pain, reduce pain within the first three months, and rapidly restore joint function . Both conventional and pulsed radiofrequency treatments have been effective in relieving pain and improving disability in patients with knee OA who have not responded to conservative treatment and have contraindications for surgery. Conventional radiofrequency therapy uses high-frequency alternating current to create thermal lesions. The thermal energy creates a zone of coagulative necrosis that includes the nerves that transmit and/or modulate pain sensation . In pulsed radiofrequency therapy, thermal tissue damage can be minimized by using pulsed high-voltage radiofrequency currents. This allows time for the heat to dissipate and generally maintains the tissue temperature near the electrode below the neurodestructive range. The mechanism by which pulsed radiofrequency provides clinical benefit is not fully understood. It appears to modulate signaling cascades, particularly in C fibers, without affecting nerve conduction in myelinated fibers . As an alternative to the thermal effects of conventional radiofrequency therapy, pulsed radiofrequency therapy has been noted to have fewer potential side effects .

In conclusion, the therapeutic effects of radiofrequency applications on improving pain and functional impairments due to knee osteoarthritis (KOA) have been demonstrated; however, the number of studies evaluating only elderly patients (aged 65 and over) is limited. Studies comparing conventional and pulsed radiofrequency treatments of the genicular nerves and evaluating their effects on geriatric parameters are limited. The primary objective of our study was to compare the effects of conventional and pulsed radiofrequency treatments of the genicular nerves under ultrasound guidance on knee pain and functional assessments in elderly patients, and the secondary objective was to determine their effects on geriatric assessments.

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

The study will be conducted at the Department of Algology at Kanuni Sultan Süleyman Training and Research Hospital by retrospectively reviewing the medical records of patients aged 65 and over diagnosed with knee osteoarthritis who underwent conventional or pulsed radiofrequency (USG)-guided radiofrequency (RF) treatment of the genicular nerves between January 2023 and March 2024. The interventional procedure is performed under sterile conditions, with the patient monitored, supported below the knee, and in slight flexion, adhering to asepsis and antisepsis guidelines. The genicular nerves are visualized using ultrasound guidance, and radiofrequency treatment is administered in conventional or pulsed mode, followed by appropriate sensory and motor stimuli. Demographic data, height, weight, duration of symptoms, comorbidities, analgesic use, pre-treatment and post-treatment 1st and 3rd month Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Numeric Rating Scale-11 (NRS-11), Tinneti Balance, Tinneti gait and performance-oriented mobility assessment (POMA), and timed up and go test will be recorded from the patient files.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • İ̇stanbul
      • Küçükçekmece, İ̇stanbul, Turkey, (507) 277-4773
        • Kanuni Sultan Suleyman Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The study will include 60 patients aged 45 years and over, diagnosed with Kellgren-Lawrence (KL) stage 3-4 knee osteoarthritis, who underwent ultrasound-guided geniculate radiofrequency (RFT) between January 2022 and January 2023 at the Algology Department of Kanuni Sultan Süleyman Training and Research Hospital. The minimum number of patients required to achieve a 10% difference (normal width = 4.5 + 0.4 mm), i.e., a difference of approximately 0.5 mm, was determined to be 30 (80% power, p<0.05). Considering the losses, the planned inclusion of 60 patients is planned.

Description

Inclusion Criteria:

  • Patients who have undergone ultrasound-guided genicular nerve RFT.
  • Patients over the age of 65 who have a diagnosis of knee OA and who cannot achieve adequate pain palliation with conservative treatments.
  • Patients with complete data to be scanned in their files.

Exclusion Criteria:-Patients who have received radiofrequency treatments other than those diagnosed with osteoarthritis

  • Patients who have received intra-articular knee injections, PRP, or hyaluronic acid injections in the last 6 months
  • Patients who have undergone knee replacement surgery
  • Patients diagnosed with malignancy
  • Patients who have received steroids for any reason in the last 6 months
  • Patients with radicular pain
  • Connective tissue diseases
  • Serious neurological or psychiatric disorders
  • Mental impairment that prevents adequate communication or cooperation Use of anticoagulant medications

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Comparison of the Effectiveness of Conventional and Pulsed Radiofrequency Treatment in Advanced Knee

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Numeric Rating Scale-11 (NRS-11): This is an 11-point scale used to describe pain. It is based solely on the patient's ability to perform activities of daily living and can be used for adults and children ages 10 and older.
Time Frame: 1 month
1 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Western Ontario and McMaster Universities. Higher scores indicate worse pain, stiffness, and functional limitations. The WOMAC consists of five items for pain (score range 0-20), two items for stiffness (score range 0-8), and 17 items for functional limi
Time Frame: 1 month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kanuni Sultan Suleyman Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2025

Primary Completion (Estimated)

August 30, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

August 1, 2025

First Submitted That Met QC Criteria

August 1, 2025

First Posted (Actual)

August 8, 2025

Study Record Updates

Last Update Posted (Actual)

August 8, 2025

Last Update Submitted That Met QC Criteria

August 1, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Radiofrequency, knee pain

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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