Image Guided Genicular Nerve Radiofrequency Ablation for Chronic Knee Osteoarthritis

March 24, 2026 updated by: Ali Sarfraz Siddiqui, Aga Khan University

Efficacy of Ultrasound vs Fluoroscopy Guided Genicular Nerve Radiofrequency Ablation for Chronic Knee Osteoarthritis: A Randomized Controlled Trial

The goal of this prospective randomized control trial is to provide continued pain relief, classically long-lasting 3 to12 months, and enhanced function in patients following: both gender; male and female, age group; >50yr, healthy volunteers along with Radiographic diagnosis of knee OA with KL grade 3 and 4 in addition of Chronic knee pain ≥ 6 months and patients with ≥50% decrease in pain strength after diagnostic genicular nerve block. The main question it aims to answer is:

Is ultrasound-guided genicular nerve RFA more efficient in lowering pain intensity at six months contrasted with fluoroscopic guided method in patients with chronic knee osteoarthritis? Researchers will compare Group A (Fluoroscopic) to Group B (Ultrasound) to see comparison in efficiency of ultrasound guided against fluoroscopic guided genicular nerves block for decrease in pain intensity and functional improvement.

Study Overview

Status

Not yet recruiting

Study Type

Interventional

Enrollment (Estimated)

52

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Both gender patients of age more than 50 years.
  • Radiographic diagnosis of knee OA with KL level 3 and 4.
  • Chronic knee pain for more than 6 months
  • Patients with more than 50% reduction in pain intensity after diagnostic genicular nerve block

Exclusion Criteria:

  • Lack of consent
  • surgery of knee
  • Patient with BMI more than 40kg/m2
  • Intra-articular steroid injection or hyaluronic acid in last 3 months
  • Localized infection at procedure site or knee.
  • Patient unable to communicate properly (Severe psychiatric illness, severe dementia and cognitive impairment).
  • Patients have moderate to severe low back pain (NRS ≥5)

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group B
Intervention group in which genicular nerves radiofrequency ablation will be done with the help ultrasound guidance.
Genicular nerves radiofrequency ablation will be done with the help of ultrasound guidance.
Active Comparator: Group A
Control group in which genicular nerves radiofrequency ablation will be done with the help of fluoroscopic guidance.
Control group in which genicular nerves radiofrequency ablation will be done with the help of fluoroscopic guidance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness of Block
Time Frame: Post procedure 2 weeks, then follow up after 2, 4 and 6 months.
Block will be considered effective if decrease in pain score from baseline is >50% at six months. And this will measure by using the 11-point Numeric Rating Scale (NRS) where 0 = no pain and 10 = worst imaginable pain.
Post procedure 2 weeks, then follow up after 2, 4 and 6 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Improvement after block
Time Frame: 6 months
Functional improvement after genicular nerve block is describe as > 20 % decrease in KOOS PS score from baseline at six months. Functional condition will be assessed using the Knee injury and osteoarthritis outcomes score-Physical function short form (KOOS-PS) tool. Minimum score is 0 and maximum is 20 which will then be converted into ratio from 0 to 100%, 0 means no functional impairment and 100 means maximum functional impairment.
6 months

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Ali Sarfraz Siddiqui, MBBS-FCPS, Aga Khan University

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 (Estimated)

May 1, 2026

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

May 31, 2027

Study Registration Dates

First Submitted

March 13, 2026

First Submitted That Met QC Criteria

March 13, 2026

First Posted (Actual)

March 17, 2026

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 24, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 2026-12711-40401

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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