Health TrialsbyHealthPanel

Unipolar Versus Bipolar Radiofrequency Ablation in Knee Osteoarthritis Pain

ConditionsBipolar Radiofrequency AblationUnipolar Radiofrequency AblationKnee OsteoarthritisPain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorTanta University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Chronic knee pain induced by infection, inflammation, tumors, and fractures.

Prior knee surgery.

Acute knee pain.

Connective tissue diseases.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Unipolar radiofrequency ablation

    Procedure/Surgery

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

  • Bipolar radiofrequency ablation

    Procedure/Surgery

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

Treatment groups

64 Participants
are divided into 2 treatment groups
Group A: Unipolar RFA (URFA) GroupExperimental treatment 1 intervention
Group B: Bipolar RFA (BRFA) GroupExperimental treatment 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tanta University

Lead sponsor

Source ClinicalTrials.gov
Apply now