AzTrials
AzTrials

Knee OsteoarthritisSAPH-KNEE-OANCT07868770

US-Guided Saphenous Block in Knee OA

A study testing Intra-articular corticosteroid injection, Ultrasound-Guided High-Volume Saphenous Nerve Block and Home-Based Exercise Program in people with Knee Osteoarthritis and Osteoarthritis, Knee, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 40 to 75 years
What is being tested?
Intra-articular corticosteroid injection, Ultrasound-Guided High-Volume Saphenous Nerve Block and Home-Based Exercise Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
2 Oct 2026to 30 Nov 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

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

Turkey (Türkiye)1 site
  • Ankara Gaziler Physical Medicine and Rehabilitation Training and Research Hospital

    Ankara, 06800

    MUHAMMET EMIR ACAR, MD, +90 545 387 61 40, muh.emiracar@gmail.com

    SEFA GUMRUK ASLAN, Assoc.Prof., +90 531 983 14 06, sefagumrukk@gmail.com

Other trials in Turkey (Türkiye)

About this study

Official title: Evaluation of the Clinical and Sonographic Effects of Ultrasound-Guided Saphenous Nerve Block in Knee Osteoarthritis

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:

Read more
  • 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.

Read the detailed description

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:

  1. Group 1 (IA Corticosteroid): Patients will receive a US-guided intra-articular injection of 40 mg (1 mL) triamcinolone acetonide mixed with 1 mL 0.9% saline (total volume: 2 mL) via a suprapatellar lateral approach using an in-plane technique.
  2. Group 2 (IA Corticosteroid + High-Volume Saphenous Nerve Block): Patients will receive the same IA corticosteroid injection as Group 1, followed by a US-guided high-volume saphenous nerve block at the mid-thigh/adductor canal level. A total of 10 mL bupivacaine solution (~0.2% final concentration, prepared with 8 mL 0.25% bupivacaine and 2 mL 0.9% saline) will be injected perineurally around the saphenous nerve with 360-degree circumferential spread.

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:

  • Primary Outcome: Functional status change assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score at T0, T1 (1st month), T2 (3rd month), and T3 (6th month).
  • Secondary Outcomes:
  1. Pain severity using Visual Analog Scale (VAS at rest and movement) at T0, T1, T2, and T3.
  2. Health-related quality of life measured by SF-36 Physical Component Summary (PCS) and Mental Component Summary (MCS) at T0, T1, T2, and T3.
  3. Saphenous nerve cross-sectional area (CSA in mm²) measured by continuous trace function at the same anatomical level using zero-pressure technique at T0, T1, and T3.
  4. Perineural vascularity scored semi-quantitatively (0-3 scale) using Power Doppler US (PRF 500-750 Hz) at T0, T1, and T3.

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.

Being tested
Intra-articular corticosteroid injection, Ultrasound-Guided High-Volume Saphenous Nerve Block, Home-Based Exercise Program
Keywords
Saphenous Nerve Block, Nerve Hydrodissection, Adductor Canal Block, Ultrasound-Guided Injection
Medical subject headings
Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intra-articular corticosteroid injectionDrug

    Also called Triamcinolone acetonide, Kenacort

    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 BlockProcedure or surgery

    Also called Adductor Canal Block, Saphenous Nerve Hydrodissection, Bupivacaine

    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 ProgramOther

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

Study groups in NCT07868770
Study groupRoleWhat they receive
Group 1: Intra-articular Corticosteroid InjectionActive comparatorParticipants 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.
Receives: Drug: Intra-articular corticosteroid injection; Other: Home-Based Exercise Program
Group 2: Intra-articular Corticosteroid + High-Volume Saphenous Nerve BlockExperimentalParticipants 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.
Receives: Drug: Intra-articular corticosteroid injection; Procedure: Ultrasound-Guided High-Volume Saphenous Nerve Block; Other: Home-Based Exercise Program

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

  2. 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.

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

Secondary outcomes (3)
  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.

    Measured: Baseline, Week 4, and Week 12 post-injection

  2. 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.

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

  3. 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.

    Measured: Up to 12 weeks post-injection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Oct 2026
  2. Study start2 Oct 2026 (estimated)
  3. Primary completion30 Apr 2027 (estimated)
  4. Study completion30 Nov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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).
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07868770
Sponsor's protocol ID
Koa14
Acronym
SAPH-KNEE-OA
Status last verified
Oct 2026
First submitted
3 Oct 2026
Last updated
9 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared to ensure participant privacy and confidentiality in accordance with institutional ethics guidelines.

Questions about this trial

What is this clinical trial studying?

A study testing Intra-articular corticosteroid injection, Ultrasound-Guided High-Volume Saphenous Nerve Block and Home-Based Exercise Program in people with Knee Osteoarthritis and Osteoarthritis, Knee, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact SEFA GUMRUK ASLAN, Assoc.Prof. (+90 531 983 14 06, sefagumrukk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score (time frame: Baseline, Week 2, Week 4, and Week 12 post-injection). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in