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

NCT07326098 | Recruiting

• 1 other identifier: 25-5.1/20
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Gonarthrosis; Primary

Keywords

gait parameters; genicular nerve block; Gonarthrosis; GNB; pedogait

Outcome Measures

Primary Outcomes (2)

• Effect on gait kinematics

  Change in gait and pressure parameters measured with the DIERS Formetric 4D analysis system.

  4 weeks

• 1. 6 minute walk test

  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 Outcomes (2)

• (VAS) for pain and fatigue

  4 weeks

• WOMAC

  4 weeks

Study Arms (2)

İntervention group

EXPERIMENTAL

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.

Procedure: genicular nerve block

Placebo group

PLACEBO COMPARATOR

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.

Procedure: Placebo injection (normal saline)

Interventions

genicular nerve block PROCEDURE

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.

Also known as: Ultrasound-guided genicular nerve block including the combination of lidocaine and triamcinolone hexacetonide

İntervention group

Placebo injection (normal saline) PROCEDURE

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.

Placebo group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Ege University: lead

Study Sites (2)

Ege University Faculty of Medicine

Izmir, Bornova, 35100, Turkey (Türkiye)

RECRUITING

Ege University Faculty of Medicine

Izmir, 35100, Turkey (Türkiye)

RECRUITING

Related Publications (1)

• Lebleu J, Fonkoue L, Bandolo E, Fossoh H, Mahaudens P, Cornu O, Detrembleur C. Lower limb kinematics improvement after genicular nerve blockade in patients with knee osteoarthritis: a milestone study using inertial sensors. BMC Musculoskelet Disord. 2020 Dec 7;21(1):822. doi: 10.1186/s12891-020-03836-8.

  PMID: 33287783 RESULT

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

triamcinolone hexacetonide; Saline Solution

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Ece Cinar, Assistant Professor

  EGE UNİVERCİTY

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sanem Cesur, Sub-Investigator

CONTACT

+905336834303; sanemtikiz@outlook.com

Ece Cinar, Assistant Professor

CONTACT

+905372257018; ececinar1@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The study is conducted as a randomized, double-blind, placebo-controlled trial. Both participants and care providers administering the injections are blinded to group assignments. Syringes are prepared and covered by an independent researcher to ensure identical appearance across groups
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 25, 2025
• First Posted: January 8, 2026
• Study Start: November 1, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 8, 2026

Record last verified: 2025-12

Locations

TU (2)