US-Guided Saphenous Block in Knee OA

Condition(s) studied

Investigational drug(s) / intervention(s)

Intra-articular corticosteroid injection: Ultrasound-guided intra-articular injection of 40 mg (1 mL) triamcinolone acetonide mixed with 1 mL 0.9% saline (total volume 2 mL) into the knee joint via a suprapatellar lateral approach.

Ultrasound-Guided High-Volume Saphenous Nerve Block: Ultrasound-guided high-volume saphenous nerve block administered at the adductor canal/mid-thigh level using 10 mL bupivacaine solution (\~0.2% final concentration, prepared with 8 mL 0.25% bupivacaine and 2 mL 0.9% saline).

Home-Based Exercise Program: Standardized 4-week home-based knee osteoarthritis exercise routine, including range of motion, isometric quadriceps, and lower extremity stretching exercises.

Study summary

The purpose of this prospective, randomized, open-label, active-controlled clinical trial is to evaluate the clinical and sonographic effects of ultrasound-guided (US-guided) high-volume saphenous nerve block combined with intra-articular corticosteroid injection compared to intra-articular corticosteroid injection alone in patients with Kellgren-Lawrence Grade 3-4 medial compartment knee osteoarthritis (OA) refractory to conservative treatment.

A total of 60 participants aged 45-75 years will be randomly assigned (1:1) into two treatment arms:

* Group 1: US-guided intra-articular corticosteroid injection (40 mg triamcinolone acetonide + 1 mL saline) + home exercise program.
* Group 2: US-guided intra-articular corticosteroid injection + US-guided high-volume saphenous nerve block (10 mL 0.2% bupivacaine solution) + home exercise program.

Clinical assessments (WOMAC, VAS, and SF-36) will be conducted at baseline (T0), 1st month (T1), 3rd month (T2), and 6th month (T3). Sonographic evaluations, including saphenous nerve cross-sectional area (CSA) and perineural vascularity via Power Doppler US, will be performed at baseline (T0), 1st month (T1), and 6th month (T3). The primary outcome is functional improvement measured by the change in WOMAC total score.

Eligibility

Primary outcome measure(s)

• Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score — Baseline, Week 2, Week 4, and Week 12 post-injection
  WOMAC is a self-administered questionnaire evaluating pain, stiffness, and physical function in knee osteoarthritis. Total score ranges from 0 to 96, where higher scores indicate worse pain, stiffness, and functional limitation.
• Change in Visual Analog Scale (VAS) Pain Score — Baseline, Week 2, Week 4, and Week 12 post-injection
  VAS measures pain intensity during activity on a 10-cm/100-mm continuous line (0 = no pain, 100 = worst imaginable pain). Higher scores indicate greater pain severity.

Trial sites (1)

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