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NCT Number: NCT07789340

Unipolar Versus Bipolar Radiofrequency Ablation in Knee Osteoarthritis Pain

This study aims to compare the efficacy of unipolar versus bipolar radiofrequency ablation (RFA) in knee osteoarthritis pain.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Osteoarthritis (OA) is one of the most common underlying causes of chronic knee pain resulting in loss of ability. Chronic knee pain due to OA is a debilitating disease. Many therapeutic options have been used to manage this pain such as physical therapy, non-steroid anti-inflammatory drugs (NSAIDs), tramadol, opioids, intraarticular hyaluronic acid, and steroids.

Radiofrequency ablation (RFA) appears to be effective for treatment of knee pain. It acts by interrupting the pain conduction through production of a thermal lesion to interrupt nociceptive signals.

A diagnostic genicular nerve block with local anesthetic is performed before genicular nerve RFA, and a positive result indicates the need for genicular RFA In conventional monopolar RFA (MRFA) technique, the localization of genicular nerves is one through sensory stimulation at the junction of epicondyle with the shaft of femur bone (near periosteum).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age > 50 years.
  • Both genders.
  • Diagnosed with chronic knee osteoarthritis (KOA) according to the American College of Rheumatology (ACR) criteria and confirmed with plain radiography as the gold standard for the diagnosis of KOA.
  • One chronic KOA pain not responding to other treatments as physiotherapy, oral analgesics, and intraarticular injection with hyaluronic acids or steroids.
  • Kellgren-Lawrence grade (II-IV).

Exclusion criteria

  • Chronic knee pain induced by infection, inflammation, tumors, and fractures.
  • Prior knee surgery.
  • Acute knee pain.
  • Connective tissue diseases.
  • Neurologic or psychiatric disorders.
  • Intra-articular knee corticosteroid or hyaluronic acids in the past 3 months.
  • Anticoagulant medication.
  • Local infection of the site of intervention.
  • Cognitive impairment.

Treatment and study plan

Unipolar radiofrequency ablation

Procedure

Patients will undergo radiofrequency ablation (RFA) of three genicular nerves (superior medial, superior lateral and inferior medial) with one cannula.

Bipolar radiofrequency ablation

Procedure

Patients will undergo radiofrequency ablation (RFA) as unipolar RFA but with two cannulas.

Primary outcomes

  1. Proportion of successful responders with a reduction 50% of pain

    Time frame: 24 weeks after the procedure

    The proportion of successful responders with a reduction 50% of Visual Analog Scale (VAS) will be recorded.

Secondary outcomes

  1. Degree of pain

    Time frame: 24 weeks after the procedure

    Knee pain will be measured by visual Analog Scale (VAS) (0 - no pain to 10-worst imaginable pain) at baseline, 1, 4, 12 and 24 weeks after the procedure during movement.

  2. Oxford Knee Score (OKS)

    Time frame: 24 weeks after the procedure

    The functional changes in the knee will be assessed by Oxford Knee Score (OKS). It is simple, valid, self-administered, joint-specific 12-item questionnaires ranging from 12 to 60, with 12 referred to the best result.

Study contacts

Contact information is provided by the study sponsor or research team.

Mohammed S Elsharkawy, MD

CONTACT

[email protected]

00201148207870

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Unipolar Versus Bipolar Radiofrequency Ablation in Knee Osteoarthritis Pain: A Randomized Single-Blinded Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 27, 2026
Registry last updated
Aug 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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