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Knee osteoarthritis (KOA) is a leading cause of chronic pain and disability. Although genicular nerve block (GNB) is an effective treatment for many patients, treatment response varies considerably. Identifying imaging biomarkers that predict clinical response may improve patient selection and optimize treatment outcomes.
This prospective observational study aims to evaluate whether the Sonographic Thigh Adjustment Ratio (STAR), calculated as anterior quadriceps muscle thickness divided by body mass index (BMI), and subcutaneous fat thickness are associated with pain relief following genicular nerve block in patients with symptomatic knee osteoarthritis. Ultrasound measurements will be obtained before the procedure, and clinical outcomes will be assessed during follow-up. The primary objective is to determine whether sonographic muscle parameters can predict treatment response after GNB.
Knee osteoarthritis is one of the most common musculoskeletal disorders worldwide and is frequently associated with chronic pain, impaired mobility, and reduced quality of life. Genicular nerve block has become an established minimally invasive treatment for patients with persistent pain despite conservative management. However, substantial variability exists in treatment response, highlighting the need for reliable predictors of clinical success.
Recent studies have suggested that ultrasound-derived muscle measurements may provide objective information regarding muscle quality and sarcopenia. The Sonographic Thigh Adjustment Ratio (STAR), defined as anterior quadriceps muscle thickness normalized to body mass index (BMI), has been proposed as an ultrasound-based indicator of muscle mass. Nevertheless, its potential role in predicting the response to interventional pain procedures has not been investigated.
This prospective observational cohort study will enroll patients with symptomatic knee osteoarthritis who undergo ultrasound-guided genicular nerve block as part of routine clinical care. Before the procedure, ultrasound measurements of anterior quadriceps muscle thickness and subcutaneous fat thickness will be obtained. STAR will be calculated by dividing anterior quadriceps muscle thickness by BMI. Clinical outcomes will be assessed using validated pain and functional outcome measures during follow-up.
The primary objective is to evaluate whether STAR predicts treatment response after genicular nerve block. Secondary objectives include investigating the predictive value of quadriceps muscle thickness and subcutaneous fat thickness individually and exploring their relationship with pain reduction and functional improvement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients With Knee Osteoarthritis Undergoing Genicular Nerve Block | Adults with symptomatic Kellgren-Lawrence grade 3-4 knee osteoarthritis undergoing ultrasound-guided genicular nerve block as part of routine clinical care. Participants undergo baseline ultrasonographic assessment of quadriceps muscle thickness, subcutaneous fat thickness, and calculation of the Sonographic Thigh Adjustment Ratio (STAR), followed by clinical follow-up at 1 and 3 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound-Guided Genicular Nerve Block | Procedure | Ultrasound-guided genicular nerve block was performed as part of routine clinical care in patients with symptomatic knee osteoarthritis. The superomedial, superolateral, and inferomedial genicular nerves were targeted using a standardized ultrasound-guided technique. A standardized injectate consisting of bupivacaine, dexamethasone, and normal saline was administered to each target nerve. The procedure was performed by an experienced pain physician using the same protocol for all participants. |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Response at 1 Month Following Genicular Nerve Block | Treatment response will be defined as a ≥50% reduction in Visual Analog Scale (VAS) pain score from baseline at 1 month after ultrasound-guided genicular nerve block. The predictive value of baseline Sonographic Thigh Adjustment Ratio (STAR) for 1-month treatment response will be evaluated. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Responder Pattern After Genicular Nerve Block | Participants will be classified according to pain response pattern after genicular nerve block: non-response, defined as less than 50% reduction in VAS pain score at 1 month; transient response, defined as at least 50% reduction at 1 month but less than 50% reduction at 3 months; and sustained response, defined as at least 50% reduction at both 1 and 3 months. The association between baseline STAR and responder pattern will be evaluated. |
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Inclusion Criteria:
Exclusion Criteria:
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Adults with symptomatic bilateral Kellgren-Lawrence grade 3-4 knee osteoarthritis referred from the Department of Physical Medicine and Rehabilitation to the Pain Medicine Clinic for ultrasound-guided genicular nerve block after failure of conservative treatment. Consecutive eligible patients meeting the inclusion criteria will be enrolled prospectively.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Health Sciences Gaziosmanpaşa Physical Therapy and Rehabilitation Training and Research Hospital | Recruiting | Istanbul | 34255 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39143682 | Result | Vilchez-Cavazos F, Gamboa Alonso AA, Simental-Mendia M, Pena-Martinez VM, Acosta-Olivo CA, Villarreal-Villarreal GA. Genicular Nerve Block for Knee Osteoarthritis: A Systematic Review and Meta-analysis of Randomized Clinical Trials. Clin J Pain. 2024 Oct 1;40(10):618-624. doi: 10.1097/AJP.0000000000001240. | |
| 37594394 | Result |
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The investigators have not yet made a final decision regarding individual participant data (IPD) sharing. Data sharing will be considered after study completion in accordance with institutional policies, ethical requirements, and applicable data protection regulations.
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| 1 month, and 3 months |
| WOMAC Score | Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). | Baseline, 1 month, and 3 months |
| Five Times Sit-to-Stand Test | Change in functional performance assessed using the Five Times Sit-to-Stand (5xSTS) test. | Baseline, 1 month, and 3 months |
| Change in Pain Intensity | Change in Visual Analog Scale (VAS) pain score from baseline after ultrasound-guided genicular nerve block. | Baseline, 1 month, and 3 months |
| Razaq S, Kara M, Ozcakar L. The Relationship Between Sarcopenic Obesity and Knee Osteoarthritis: The SARCOB Study. Eur J Rheumatol. 2023 Aug 18. doi: 10.5152/eurjrheum.. Online ahead of print. |
| 32941253 | Result | Kara M, Kaymak B, Ata AM, Ozkal O, Kara O, Baki A, Sengul Aycicek G, Topuz S, Karahan S, Soylu AR, Cakir B, Halil M, Ozcakar L. STAR-Sonographic Thigh Adjustment Ratio: A Golden Formula for the Diagnosis of Sarcopenia. Am J Phys Med Rehabil. 2020 Oct;99(10):902-908. doi: 10.1097/PHM.0000000000001439. |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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