US-Guided Saphenous Block in Knee OA
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-75
SponsorGaziler Physical Medicine and Rehabilitation Education and Research Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Patients aged between 40 and 75 years
Diagnosis of primary knee osteoarthritis according to the American College of Rheumatology (ACR) criteria
Kellgren-Lawrence grade 2 or 3 knee osteoarthritis on weight-bearing radiographs
Moderate to severe knee pain (Visual Analog Scale score ≥ 4/10) lasting for at least 3 months
Disqualifiers
Kellgren-Lawrence grade 1 or grade 4 knee osteoarthritis
History of intra-articular corticosteroid injection in the target knee within the past 3 months
History of intra-articular hyaluronic acid or platelet-rich plasma (PRP) injection in the target knee within the past 6 months
Previous knee surgery or arthroplasty on the target knee
Trial design
Design model
Parallel
Treatments tested in this trial
Intra-articular corticosteroid injection
DrugUltrasound-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
Procedure/SurgeryUltrasound-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
Other interventionStandardized 4-week home-based knee osteoarthritis exercise routine, including range of motion, isometric quadriceps, and lower extremity stretching exercises.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Group 1: Intra-articular Corticosteroid InjectionActive comparator 2 interventions
Group B: Group 2: Intra-articular Corticosteroid + High-Volume Saphenous Nerve BlockExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
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-injection2
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-injectionSecondary outcomes
1
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-injection2
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-injection3
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-injectionSponsors and contacts
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Source ClinicalTrials.gov
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