US-Guided Saphenous Block in Knee OA

NCT07868770 | Not Yet Recruiting

• 1 other identifier: Koa14
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Knee Pain; Knee Osteoarthritis; Osteoarthritis, Knee; Gonarthrosis

Keywords

Saphenous Nerve Block; Nerve Hydrodissection; Adductor Canal Block; Ultrasound-Guided Injection

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline, Week 2, Week 4, and Week 12 post-injection

Secondary Outcomes (3)

• Change in Short Form-36 (SF-36) Health Survey Score

  Baseline, Week 4, and Week 12 post-injection

• Global Perceived Effect (GPE) Scale Score

  Week 2, Week 4, and Week 12 post-injection

• Rescue Analgesic Consumption and Adverse Events

  Up to 12 weeks post-injection

Study Arms (2)

Group 1: Intra-articular Corticosteroid Injection

ACTIVE COMPARATOR

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

Group 2: Intra-articular Corticosteroid + High-Volume Saphenous Nerve Block

EXPERIMENTAL

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

Interventions

Intra-articular corticosteroid injection DRUG

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

Group 1: Intra-articular Corticosteroid Injection; Group 2: Intra-articular Corticosteroid + High-Volume Saphenous Nerve Block

Ultrasound-Guided High-Volume Saphenous Nerve Block PROCEDURE

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

Group 2: Intra-articular Corticosteroid + High-Volume Saphenous Nerve Block

Home-Based Exercise Program OTHER

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

Group 1: Intra-articular Corticosteroid Injection; Group 2: Intra-articular Corticosteroid + High-Volume Saphenous Nerve Block

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Willingness and ability to participate in the study and sign the written informed consent form

You may not qualify if:

• 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
• Secondary knee osteoarthritis (e.g., post-traumatic, inflammatory arthritis, gout, septic arthritis)
• Severe systemic diseases, active infection, or localized skin infection at the injection site
• Coagulopathy or ongoing anticoagulant therapy
• Known allergy or hypersensitivity to local anesthetics, triamcinolone acetonide, or bupivacaine
• Severe cognitive impairment or inability to comply with follow-up protocols and home exercises

Sponsors & Collaborators

• Gaziler Physical Medicine and Rehabilitation Education and Research Hospital: lead

Study Sites (1)

Ankara Gaziler Physical Medicine and Rehabilitation Training and Research Hospital

Ankara, 06800, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Adrenal Cortex Hormones; Triamcinolone Acetonide; Triamcinolone; Bupivacaine

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• SEFA GUMRUK ASLAN, Assoc.Prof.

  Ankara Gaziler Physical Medicine and Rehabilitation Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

SEFA GUMRUK ASLAN, Assoc.Prof.

CONTACT

+90 531 983 14 06; sefagumrukk@gmail.com

MUHAMMET EMİR ACAR, MD

CONTACT

+90 545 387 61 40; muh.emiracar@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to differences in anatomical injection sites and techniques between groups, blinding of participants and the administering physician was not feasible. To minimize potential assessment bias, outcome measures (WOMAC, VAS, SF-36) will be completed independently by the participants as self-reported questionnaires without investigator guidance.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: This is a single-center, prospective, randomized, open-label, active-controlled trial with two parallel assignment arms (1:1 allocation ratio). Block randomization with a block size of 4 will be used to assign 60 patients into two intervention groups: 1. Group 1 (Active Control): US-guided intra-articular corticosteroid injection + home exercises (n=30). 2. Group 2 (Intervention): US-guided intra-articular corticosteroid injection + US-guided high-volume saphenous nerve block + home exercises (n=30).

Study Record Dates

• First Submitted: October 3, 2026
• First Posted: October 9, 2026
• Study Start: October 2, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: October 9, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)