An interventional study of Intra-articular corticosteroid injection and Ultrasound-Guided High-Volume Saphenous Nerve Block in Knee Osteoarthritis, Osteoarthritis, Knee and Gonarthrosis, sponsored by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital · Not applicable, Interventional, and Treatment
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:
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.
Knee osteoarthritis (OA) is a progressive degenerative joint disorder characterized by chronic pain and functional limitation. Beyond cartilage loss, peripheral sensitization and neuroinflammatory mechanisms play crucial roles, particularly in advanced stages (Kellgren-Lawrence Grade 3-4). The saphenous nerve provides essential sensory innervation to the medial and anteromedial knee joint. Combining US-guided intra-articular corticosteroid injection with a high-volume perineural saphenous nerve block is hypothesized to suppress peripheral nociceptive transmission and promote mechanical hydrodissection of perineural adhesions, offering enhanced pain relief and functional restoration.
STUDY DESIGN AND RANDOMIZATION:
This single-center, prospective, randomized, open-label, active-controlled study will enroll 60 patients aged 45-75 years with primary medial compartment knee OA (KL grade 3-4) refractory to conservative therapy for at least 3 months. Block randomization (block size of 4) will allocate patients into two equal groups (n=30 per group).
INTERVENTIONS:
Both groups will perform a standardized 4-week home-based exercise program (5 days/week, 25-30 min/day) focusing on muscle strengthening and stretching.
OUTCOME MEASURES:
Secondary Outcomes:
STATISTICAL POWER:
Sample size was calculated using G*Power 3.1.9 based on a 20% MCID in WOMAC pain subscore (effect size d=0.7, alpha=0.05, power=80%), indicating a minimum of 26 patients per group. Factoring in a 15% drop-out rate, 30 patients per group (total N=60) will be recruited.
3,391 studies on the registry are indexed under Osteoarthritis, Knee; 628 are open to participants now.
This study's planned enrollment of 60 is below the median of 69 across 2,808 interventional studies indexed under Osteoarthritis, Knee.
Browse Osteoarthritis, Knee studies →Gaziler Physical Medicine and Rehabilitation Education and Research Hospital is the lead sponsor of 82 studies on the registry; 12 are open to participants now.
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Exclusion Criteria:
Participants will receive a US-guided intra-articular corticosteroid injection consisting of 40 mg (1 mL) triamcinolone acetonide mixed with 1 mL 0.9% saline (total volume 2 mL) via a suprapatellar lateral approach. Participants will also perform a standardized 4-week home-based exercise program.
Drug: Intra-articular corticosteroid injection · Other: Home-Based Exercise Program
Participants will receive a US-guided intra-articular corticosteroid injection (40 mg triamcinolone acetonide + 1 mL 0.9% saline, total 2 mL) combined with a US-guided high-volume saphenous nerve block (10 mL bupivacaine solution, \~0.2% final concentration, prepared with 8 mL 0.25% bupivacaine and 2 mL 0.9% saline) at the adductor canal/mid-thigh level. Participants will also perform a standardized 4-week home-based exercise program.
Drug: Intra-articular corticosteroid injection · Procedure: Ultrasound-Guided High-Volume Saphenous Nerve Block · Other: Home-Based Exercise Program
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.
Also known as: Triamcinolone acetonide, Kenacort
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).
Also known as: Adductor Canal Block, Saphenous Nerve Hydrodissection, Bupivacaine
Standardized 4-week home-based knee osteoarthritis exercise routine, including range of motion, isometric quadriceps, and lower extremity stretching exercises.
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score
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.
Time frame: Baseline, Week 2, Week 4, and Week 12 post-injection
Change in Visual Analog Scale (VAS) Pain Score
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.
Time frame: Baseline, Week 2, Week 4, and Week 12 post-injection
Change in Short Form-36 (SF-36) Health Survey Score
SF-36 evaluates health-related quality of life across 8 domains (Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, Mental Health), yielding Physical Component Summary (PCS) and Mental Component Summary (MCS) scores. Scores range from 0 to 100, where higher scores represent better health status/quality of life.
Time frame: Baseline, Week 4, and Week 12 post-injection
Global Perceived Effect (GPE) Scale Score
GPE measures the patient's subjective perception of overall treatment response and improvement on a 7-point Likert scale ranging from 1 ('vastly improved') to 7 ('vastly worsened'). Lower scores indicate greater treatment satisfaction and recovery.
Time frame: Week 2, Week 4, and Week 12 post-injection
Rescue Analgesic Consumption and Adverse Events
Total amount of rescue analgesic (paracetamol) consumed by participants (recorded via patient diaries in grams) and the incidence/severity of any local or systemic adverse events related to the procedures or injected medications.
Time frame: Up to 12 weeks post-injection
Plan to share: No — Individual participant data will not be shared to ensure participant privacy and confidentiality in accordance with institutional ethics guidelines.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Gaziler Physical Medicine and Rehabilitation Education and Research Hospital