Efficacy of Ultrasound-Guided Genicular Nerve Block in Patients With Gonarthrosis: A Randomized, Placebo-Controlled, Double-Blind Study

April 6, 2026 updated by: Ece Cinar, Ege University

This study planned to enroll a minimum of 30 patients aged 50 years and older, with a diagnosis of gonarthrosis classified as stage 2 or higher according to the Kellgren-Lawrence grading system, and who report complaints of knee pain and walking difficulties. Patients will be randomized into two groups, and they will be blinded to the group to which they are assigned.

In the first group, ultrasound-guided genicular nerve block will be performed using a combination of lidocaine and triamcinolone hexacetonide injection (4 mL Priloc 2% + 1 mL Artropan 20 mg). In the second group, a placebo injection (5 mL saline solution) will be administered. Both groups will be instructed to follow an appropriate exercise program after the treatment.

Patients will undergo a detailed physical examination, 6-minute walk test, VAS pain score, WOMAC questionnaire, and 3D kinematic gait analysis with pressure parameters evaluated by a blinded researcher. Evaluations will take place before treatment, 1 hour after treatment, and 1 month post-treatment.

The collected data will be analyzed for differences between the two groups and changes over time. The potential positive effects of the treatment will be measured and compared with the placebo group to assess the therapeutic efficacy.

Study Overview

Detailed Description

In addition to the fact that genicular nerve block is highlighted in the literature as a potential alternative to surgery, it is also crucial to consider the reality that the pain symptoms in these patients have a more significant negative impact on walking than initially expected, potentially creating a comorbidity of its own. Given this, this study aims to contribute to the medical literature by observing the improvement in walking parameters secondary to the reduction of pain symptoms in patients with gonarthrosis.

Study Type

Interventional

Enrollment (Estimated)

30

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 Locations

      • Izmir, Turkey (Türkiye), 35100
        • Ege University Faculty of Medicine
    • BORNOVA
      • Izmir, BORNOVA, Turkey (Türkiye), 35100
        • Ege University Faculty of Medicine

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:

  • Knee pain persisting for 3 months or longer
  • Diagnosis of gonarthrosis with Grade 2 or higher tibiofemoral osteoarthritis detected on plain radiographs
  • Patients aged 50 years and older
  • Continued pain despite conservative treatment (exercise, simple analgesics such as paracetamol, or nonsteroidal anti-inflammatory drugs)

Exclusion Criteria:

  • Clinical diagnoses that could cause knee pain other than gonarthrosis (rheumatologic diseases, secondary osteoarthritis, fractures, etc.)
  • Signs of inflammation/exacerbation
  • Infection at the injection site or skin lesions
  • Diagnosis of malignancy
  • Gait impairment (the patient must be able to ambulate independently)
  • Known allergy to study medications
  • Previous knee surgery
  • Uncontrolled comorbid conditions such as diabetes mellitus or hypertension, which contraindicate corticosteroid use

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: İntervention group

Ultrasound-guided genicular nerve block will be performed using a combination of 4 mL Priloc 2% (lidocaine) and 1 mL Artropan 20 mg (triamcinolone hexacetonide).

The syringe's outer part will be covered by an independent researcher to conceal the contents.

All participants will also perform a home exercise program: quadriceps strengthening and knee isometric exercises.

Genicular nerve block performed with pharmacological agents under ultrasound guidance is minimally invasive compared to other block techniques. It can be carried out in an outpatient setting with attention to sterility, does not involve radiation, does not require procedural surgical preparations, and is less costly both for the patient and the healthcare system. Furthermore, it has fewer side effects, with many studies reporting no side effects at all.
Other Names:
  • Ultrasound-guided genicular nerve block including the combination of lidocaine and triamcinolone hexacetonide
Placebo Comparator: Placebo group

A placebo injection with 5 mL saline solution will be administered under the same sterile and ultrasound-guided conditions.

The syringe's outer part will be covered by an independent researcher to conceal the contents.

All participants will also perform a home exercise program: quadriceps strengthening and knee isometric exercises.

A placebo injection with 5 mL saline solution will be administered under the same sterile and ultrasound-guided conditions as the active group.

The syringe will be covered by an independent researcher to conceal the contents, ensuring identical appearance across groups.

All participants will also perform a home exercise program: quadriceps strengthening and knee isometric exercises.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect on gait kinematics
Time Frame: 4 weeks
Change in gait and pressure parameters measured with the DIERS Formetric 4D analysis system.
4 weeks
1. 6 minute walk test
Time Frame: 4 weeks
It is a test used to assess the level of functional exercise or functional capacity. The patient is asked to walk, but not run, in a 25 m long corridor at the highest possible speed without stopping. At the end of 6 minutes, the number of metres walked by the patient is recorded. The 6 min walk test is an evaluation criterion used in routine and clinical research to assess functional capacity in many diseases such as heart failure, general arthrosis, multiple sclerosis.
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
(VAS) for pain and fatigue
Time Frame: 4 weeks
Severity of pain that the participants have had in the past week was evaluated by using visual analogue scale (VAS) on a 10-cm horizontal line where 0-cm represented "no pain" and 10 cm the "worst imaginable pain" Severity of fatigue experienced by the participants in the past week was assessed by using VAS on a 10-cm horizontal line where 0-cm represented "not tired at all" and 10-cm "extremely tired"
4 weeks
WOMAC
Time Frame: 4 weeks
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a valid and reliable questionnaire frequently used in clinical and research settings for patients with knee osteoarthritis. It consists of 24 questions and includes three subcategories: pain, stiffness, and physical function. The patient fills out the questionnaire themselves. The pain subcategory is assessed with five questions, stiffness with two questions, and physical function with 17 questions. Each question is scored according to a Likert scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe. The subcategories are evaluated independently. Higher scores on the questionnaire indicate a greater degree of disability.
4 weeks

Collaborators and Investigators

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

Sponsor

Investigators

  • Principal Investigator: Ece Cinar, Assistant Professor, EGE UNİVERCİTY

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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 (Actual)

February 1, 2026

Primary Completion (Estimated)

August 30, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

December 25, 2025

First Submitted That Met QC Criteria

December 25, 2025

First Posted (Actual)

January 8, 2026

Study Record Updates

Last Update Posted (Actual)

April 7, 2026

Last Update Submitted That Met QC Criteria

April 6, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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