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

Ege University

Status: Enrolling

Conditions: Gonarthrosis; Primary

Treatments: Procedure: genicular nerve block; Procedure: Placebo injection (normal saline)

Study type: Interventional

Funder types: Other

Identifiers

NCT07326098

25-5.1/20

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups, including a placebo group

İntervention group

Experimental group

Description:

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.

Treatment:

Procedure: genicular nerve block

Placebo group

Placebo Comparator group

Description:

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.

Treatment:

Procedure: Placebo injection (normal saline)