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RecruitingNCT07789340Updated Sep 1, 2026

Unipolar Versus Bipolar Radiofrequency Ablation in Knee Osteoarthritis Pain

An interventional study of Unipolar radiofrequency ablation and Bipolar radiofrequency ablation in Bipolar Radiofrequency Ablation, Unipolar Radiofrequency Ablation and Knee Osteoarthritis, sponsored by Tanta University. Recruiting at 1 site in Egypt. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-09-01.

Sponsored by Tanta University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
50 Years and older
Sex
All
01

Study summary

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

Read the detailed description

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).

02

Conditions studied

  • Bipolar Radiofrequency Ablation
  • Unipolar Radiofrequency Ablation
  • Knee Osteoarthritis
  • Pain
03

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
64 participants (estimated)

Study arms

  • Experimental
    Unipolar RFA (URFA) Group

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

    Procedure: Unipolar radiofrequency ablation

  • Experimental
    Bipolar RFA (BRFA) Group

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

    Procedure: Bipolar radiofrequency ablation

Interventions

  • ProcedureUnipolar radiofrequency ablation

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

  • ProcedureBipolar radiofrequency ablation

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

05

What researchers measure

Primary outcomes

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

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

    Time frame: 24 weeks after the procedure

Secondary outcomes

  1. Degree of pain

    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.

    Time frame: 24 weeks after the procedure

  2. Oxford Knee Score (OKS)

    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.

    Time frame: 24 weeks after the procedure

06

Study locations

1 of 1 sites recruiting
07

References and documents

Individual participant data

Plan to share: Yes — The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Supporting information: Study protocol

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07789340
Lead sponsor
Tanta University
Responsible party
Mohammed Said ElSharkawy (Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt., Tanta University) — Principal investigator
First posted
Aug 27, 2026
Start date
Aug 29, 2026 (estimated)
Primary completion
Jun 1, 2027 (estimated)
Completion
Jun 1, 2027 (estimated)
Last update
Sep 1, 2026

Study contacts

Mohammed S Elsharkawy, MD
Contact
mselsharkawy@med.tanta.edu.eg
00201148207870

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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