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Active Not RecruitingNCT07326098

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

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
30 (estimated)
Sponsor
Ege University · Academic / Other
Sex
All
Age
50 Years
Healthy volunteers
Not accepted

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.

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREgenicular nerve blockGenicular 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.
PROCEDUREPlacebo injection (normal saline)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.

Timeline

Start date
2026-02-01
Primary completion
2026-08-30
Completion
2026-12-01
First posted
2026-01-08
Last updated
2026-04-07

Locations

2 sites across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT07326098. Inclusion in this directory is not an endorsement.