Sonographic Thigh Adjustment Ratio and Subcutaneous Fat Thickness as Predictors of Genicular Nerve Block Response in Knee Osteoarthritis

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age45+
SponsorGaziosmanpasa Research and Education Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥45 years.

Symptomatic bilateral knee osteoarthritis with Kellgren-Lawrence grade 3 or 4.

Visual Analog Scale (VAS) pain score ≥4 at rest or during movement.

Scheduled to undergo first ultrasound-guided genicular nerve block.

Disqualifiers

Inflammatory arthritis, rheumatoid arthritis, or crystal arthropathy.

Previous knee surgery or knee prosthesis.

Active local or systemic infection.

Anticoagulant therapy or bleeding disorders.

Trial population

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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Ultrasound-Guided Genicular Nerve Block

    Procedure/Surgery

    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.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Patients With Knee Osteoarthritis Undergoing Genicular Nerve Block1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
1 month

Secondary outcomes

1

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.

Time frame
1 month, and 3 months
2

WOMAC Score

The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a self-administered questionnaire used to evaluate knee and hip osteoarthritis. The global score ranges from 0 to 96, where 0 represents the best possible outcome (no pain or functional limitations) and 96 represents the worst possible outcome (severe pain and maximal functional limitations). Higher scores indicate a worse clinical outcome.

Time frame
Baseline, 1 month, and 3 months
3

Five Times Sit-to-Stand Test

Change in functional performance assessed using the Five Times Sit-to-Stand (5xSTS) test. The Five Times Sit-to-Stand (5xSTS) test assesses functional lower extremity strength and transitional movements. The outcome is recorded as the total time (in seconds) required for the participant to complete five consecutive sit-to-stand cycles as quickly as possible from a standard chair. The minimum possible time is 0 seconds, and a maximum cutoff score of 30 seconds is applied for participants who are unable to complete the task. Higher scores (longer times) indicate a worse outcome (poorer functional performance and lower extremity strength).

Time frame
Baseline, 1 month, and 3 months
4

Change in Pain Intensity

Change in Visual Analog Scale (VAS) pain score from baseline after ultrasound-guided genicular nerve block. Pain intensity is assessed using the Visual Analog Scale (VAS). The scale consists of a horizontal line where the minimum value is 0 (representing "no pain") and the maximum value is 10 (representing "the worst possible pain"). Participants mark their current pain level on this line. Higher scores indicate a worse outcome (greater pain intensity).

Time frame
Baseline, 1 month, and 3 months

Other outcomes

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