ClinicalTrials.gg
RecruitingNCT07789340Updated Nov 4, 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 2026-11-04.

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

From the registry’s dates

  • Started Aug 2026; still recruiting 2 months later.
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

In context

Osteoarthritis, Knee

3,292 studies on the registry are indexed under Osteoarthritis, Knee; 623 are open to participants now.

This study's planned enrollment of 64 is close to the median of 68 across 2,714 interventional studies indexed under Osteoarthritis, Knee.

Browse Osteoarthritis, Knee studies →

Lead sponsor

Tanta University is the lead sponsor of 1,010 studies on the registry; 321 are open to participants now.

Of its 15 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .
  • 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 or hyaluronic acids in the past 3 months.
  • Anticoagulant medication.
  • Local infection of the site of intervention.
  • Cognitive impairment.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

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.

06

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

07

Study locations

1 of 1 sites recruiting
08

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

Time frame: After the end of study for one year.

Access criteria: The data will be available upon a reasonable request from the corresponding author.

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2026 (actual). Primary completion is estimated for Jun 2027, 9 months after the start.

Of 1,111 non-industry interventional studies with no phase under Osteoarthritis, Knee, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 36. This study's planned 9 months is below that.

Counting every sponsor, half of 1,251 studies reached it within 18 months; a quarter within 8 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 24, 2026
First posted
Aug 27, 2026
StartActual
Aug 29, 2026
Primary completionEst.
Jun 1, 2027
CompletionEst.
Jun 1, 2027
Last update
Nov 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date and date precision
1 update, last Nov 4, 2026
Show all 1 update
  1. Nov 4, 2026
    Minor edits only
    + 2 other changes: verification date and date precision

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

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
Primary completion
Jun 1, 2027 (estimated)
Completion
Jun 1, 2027 (estimated)
Last update
Nov 4, 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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