NCT07174167

Brief Summary

The goal of this clinical trial is to evaluate whether genicular nerve block (GNB) is effective in reducing pain in patients with knee osteoarthritis. It will also assess the comparative efficacy of different injection protocols. The main questions it aims to answer are: Does genicular nerve block with corticosteroid and local anesthetic provide superior pain relief compared with local anesthetic alone or placebo? Are there differences in clinical outcomes between the three treatment groups? Researchers will compare three groups: GNB with corticosteroid plus local anesthetic GNB with local anesthetic alone Sham procedure with saline (placebo control) Participants will: Receive the assigned injection protocol in accordance with their group Be evaluated at baseline and scheduled follow-up visits for pain intensity and functional status Report their pain scores and functional limitations using standardized assessment tools

Trial Health

87
On Track

Trial Health Score

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

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

April 1, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 2, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 15, 2025

Completed
Last Updated

November 28, 2025

Status Verified

November 1, 2025

Enrollment Period

11 months

First QC Date

September 2, 2025

Last Update Submit

November 23, 2025

Conditions

Keywords

genicular nerve blockknee osteoarthritispaindisabilitygonarthrosis

Outcome Measures

Primary Outcomes (1)

  • Pain intensity

    Visual Analog Scale (VAS): The VAS assesses pain intensity on a 10-centimeter scale. Patients indicate their pain levels using two verbal descriptors at the end of each scale.

    at baseline, 1 week, and 1 month after treatment

Secondary Outcomes (3)

  • Functional status using WOMAC

    baseline, 1 week, and 1 month after treatment

  • Functional status using 40-Meter Fast Walking Test

    at baseline, 1 week, and 1 month after treatment

  • Pressure Pain Threshold (PPT)

    baseline, 1 week, and 1 month after treatment

Other Outcomes (1)

  • Ultrasound evaluation

    baseline

Study Arms (3)

genicular nerve block with local anesthetic

ACTIVE COMPARATOR

Group 1 (GNB with local anesthetic only): Patients received a genicular nerve block (GNB) with 6 mL of 2% prilocaine and participated in a knee exercise program.

Drug: Genicular nerve block with prilocaine

genicular nerve block with local anesthetic and corticosteroid

ACTIVE COMPARATOR

Group 2 (GNB with local anesthetic and corticosteroid): Patients received GNB with 5 mL of 2% prilocaine in combination with 1 mL/40 mg of triamcinolone and followed the same exercise regimen.

Drug: genicular nerve block with prilocaine and triamcinolone

sham injection with saline

SHAM COMPARATOR

Group 3 (Control group): Patients received a placebo injection (6 mL of 0.9% saline) with the knee exercise program.

Drug: Sham injection

Interventions

ultrasound guided genicular nerve block (GNB) injecting 6 mL of 2% prilocaine to the genicular nerves

Also known as: group 1
genicular nerve block with local anesthetic

ultrasound guided genicular nerve block (GNB) injecting 5 mL of 2% prilocaine in combination with 1 mL/40 mg of triamcinolone to the genicular nerves

Also known as: group 2
genicular nerve block with local anesthetic and corticosteroid

placebo injection using 6 mL of 0.9% saline to knee region other than genicular nerves

Also known as: group 3
sham injection with saline

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age between 45 and 75
  • diagnosed with knee osteoarthritis (OA) according to the American College of Rheumatology (ACR) criteria
  • possessing a Kellgren-Lawrence radiological grade of 2-3

You may not qualify if:

  • any joint injection to the target knee in the past 3 months
  • physical therapy for the target knee within the last 3 months
  • previous knee surgery
  • inflammatory rheumatic diseases
  • active lumbar radiculopathy on the same side
  • neurological disorders (e.g., Alzheimer's or dementia)
  • uncontrolled cardiopulmonary diseases
  • pregnancy or lactation
  • obesity (body mass index \[BMI\] \>35)
  • presence of a pacemaker
  • active malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haydarpasa Numune Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (4)

  • Li W, Xu F, Chen F, Cao L, Bao X. Effect of Genicular Nerve Block (GNB) on Pain in Lesions of the Knee Joint: A Meta-Analysis of Randomized Controlled Trials. J Pain Res. 2025 Jan 30;18:511-522. doi: 10.2147/JPR.S503937. eCollection 2025.

    PMID: 39901967BACKGROUND
  • Kim DH, Lee MS, Lee S, Yoon SH, Shin JW, Choi SS. A Prospective Randomized Comparison of the Efficacy of Ultrasound- vs Fluoroscopy-Guided Genicular Nerve Block for Chronic Knee Osteoarthritis. Pain Physician. 2019 Mar;22(2):139-146.

    PMID: 30921977BACKGROUND
  • Kim DH, Choi SS, Yoon SH, Lee SH, Seo DK, Lee IG, Choi WJ, Shin JW. Ultrasound-Guided Genicular Nerve Block for Knee Osteoarthritis: A Double-Blind, Randomized Controlled Trial of Local Anesthetic Alone or in Combination with Corticosteroid. Pain Physician. 2018 Jan;21(1):41-52.

    PMID: 29357330BACKGROUND
  • Shanahan EM, Robinson L, Lyne S, Woodman R, Cai F, Dissanayake K, Paddick K, Cheung G, Voyvodic F. Genicular Nerve Block for Pain Management in Patients With Knee Osteoarthritis: A Randomized Placebo-Controlled Trial. Arthritis Rheumatol. 2023 Feb;75(2):201-209. doi: 10.1002/art.42384. Epub 2022 Nov 11.

    PMID: 36369781BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, KneePain

Interventions

PrilocaineTriamcinolonesalicylhydroxamic acid

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

September 2, 2025

First Posted

September 15, 2025

Study Start

April 1, 2023

Primary Completion

February 10, 2024

Study Completion

July 1, 2024

Last Updated

November 28, 2025

Record last verified: 2025-11

Locations