NCT07475793

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
11mo left

Started May 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress12%
May 2026May 2027

First Submitted

Initial submission to the registry

March 13, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 17, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2027

Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

12 months

First QC Date

March 13, 2026

Last Update Submit

March 24, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Effectiveness of Block

    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 Outcomes (1)

  • Functional Improvement after block

    6 months

Study Arms (2)

Group B

EXPERIMENTAL

Intervention group in which genicular nerves radiofrequency ablation will be done with the help ultrasound guidance.

Procedure: Ultrasound Guided

Group A

ACTIVE COMPARATOR

Control group in which genicular nerves radiofrequency ablation will be done with the help of fluoroscopic guidance.

Procedure: Fluoroscope Guided

Interventions

Genicular nerves radiofrequency ablation will be done with the help of ultrasound guidance.

Group B

Control group in which genicular nerves radiofrequency ablation will be done with the help of fluoroscopic guidance.

Group A

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Ali Sarfraz Siddiqui, MBBS-FCPS

    Aga Khan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ali Sarfraz Siddiqui, MBBS-FCPS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 13, 2026

First Posted

March 17, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

May 31, 2027

Last Updated

March 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share