Genicular Nerve Block in Chronic Knee Osteoarthritis (GNB-KOA-RCT)

Haydarpasa Numune Training and Research Hospital

Status: Completed

Conditions: Gonarthritis; Genicular Nerve Block; Gonarthrosis; Primary

Treatments: Drug: genicular nerve block with prilocaine and triamcinolone; Drug: Genicular nerve block with prilocaine; Drug: Sham injection

Study type: Interventional

Funder types: Other

Identifiers

NCT07174167

KAEK 2023/58

Details and patient eligibility

About

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

Enrollment: 81 patients

Sex: All

Ages: 45 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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81 participants in 3 patient groups

genicular nerve block with local anesthetic

Active Comparator group

Description:

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.

Treatment:

Drug: Genicular nerve block with prilocaine

genicular nerve block with local anesthetic and corticosteroid

Active Comparator group

Description:

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.

Treatment:

Drug: genicular nerve block with prilocaine and triamcinolone

sham injection with saline

Sham Comparator group

Description:

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

Treatment:

Drug: Sham injection