Gonarthrosis; PrimaryNCT07326098
Efficacy of Ultrasound-Guided Genicular Nerve Block in Patients With Gonarthrosis: A Randomized, Placebo-Controlled, Double-Blind Study
A study testing genicular nerve block in people with Gonarthrosis; Primary, run by Ege University at 2 sites in Turkey (Türkiye).
Trial summary
This study planned to enroll a minimum of 30 patients aged 50 years and older, with a diagnosis of gonarthrosis classified as stage 2 or higher according to the Kellgren-Lawrence grading system, and who report complaints of knee pain and walking difficulties. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Gonarthrosis; Primary
- What is being tested?
- genicular nerve block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Feb 2026to 1 Dec 2026
- Phase
- Interventional
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Knee pain persisting for 3 months or longer
- Diagnosis of gonarthrosis with Grade 2 or higher tibiofemoral osteoarthritis detected on plain radiographs
- Patients aged 50 years and older
- Continued pain despite conservative treatment (exercise, simple analgesics such as paracetamol, or nonsteroidal anti-inflammatory drugs)
Who cannot join
- Clinical diagnoses that could cause knee pain other than gonarthrosis (rheumatologic diseases, secondary osteoarthritis, fractures, etc.)
- Signs of inflammation/exacerbation
- Infection at the injection site or skin lesions
- Diagnosis of malignancy
- Gait impairment (the patient must be able to ambulate independently)
- Known allergy to study medications
- Previous knee surgery
- Uncontrolled comorbid conditions such as diabetes mellitus or hypertension, which contraindicate corticosteroid use
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Ege University Faculty of Medicine
Izmir, BORNOVA, 35100
Ege University Faculty of Medicine
Izmir, 35100
About this study
This study planned to enroll a minimum of 30 patients aged 50 years and older, with a diagnosis of gonarthrosis classified as stage 2 or higher according to the Kellgren-Lawrence grading system, and who report complaints of knee pain and walking difficulties. Patients will be randomized into two groups, and they will be blinded to the group to which they are assigned.
In the first group, ultrasound-guided genicular nerve block will be performed using a combination of lidocaine and triamcinolone hexacetonide injection (4 mL Priloc 2% + 1 mL Artropan 20 mg). In the second group, a placebo injection (5 mL saline solution) will be administered. Both groups will be instructed to follow an appropriate exercise program after the treatment.
Read more
Patients will undergo a detailed physical examination, 6-minute walk test, VAS pain score, WOMAC questionnaire, and 3D kinematic gait analysis with pressure parameters evaluated by a blinded researcher. Evaluations will take place before treatment, 1 hour after treatment, and 1 month post-treatment.
The collected data will be analyzed for differences between the two groups and changes over time. The potential positive effects of the treatment will be measured and compared with the placebo group to assess the therapeutic efficacy.
Read the detailed description
In addition to the fact that genicular nerve block is highlighted in the literature as a potential alternative to surgery, it is also crucial to consider the reality that the pain symptoms in these patients have a more significant negative impact on walking than initially expected, potentially creating a comorbidity of its own. Given this, this study aims to contribute to the medical literature by observing the improvement in walking parameters secondary to the reduction of pain symptoms in patients with gonarthrosis.
- Conditions
- Gonarthrosis; Primary
- Being tested
- genicular nerve block, Placebo injection (normal saline)
- Keywords
- gait parameters, genicular nerve block, Gonarthrosis, GNB, pedogait
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
genicular nerve blockProcedure or surgery
Also called Ultrasound-guided genicular nerve block including the combination of lidocaine and triamcinolone hexacetonide
Genicular nerve block performed with pharmacological agents under ultrasound guidance is minimally invasive compared to other block techniques. It can be carried out in an outpatient setting with attention to sterility, does not involve radiation, does not require procedural surgical preparations, and is less costly both for the patient and the healthcare system. Furthermore, it has fewer side effects, with many studies reporting no side effects at all.
Placebo injection (normal saline)Procedure or surgery
A placebo injection with 5 mL saline solution will be administered under the same sterile and ultrasound-guided conditions as the active group.
The syringe will be covered by an independent researcher to conceal the contents, ensuring identical appearance across groups.
All participants will also perform a home exercise program: quadriceps strengthening and knee isometric exercises.
| Study group | Role | What they receive |
|---|---|---|
| İntervention group | Experimental | Ultrasound-guided genicular nerve block will be performed using a combination of 4 mL Priloc 2% (lidocaine) and 1 mL Artropan 20 mg (triamcinolone hexacetonide).
The syringe's outer part will be covered by an independent researcher to conceal the contents.
All participants will also perform a home exercise program: quadriceps strengthening and knee isometric exercises. Receives: Procedure: genicular nerve block |
| Placebo group | Placebo comparator | A placebo injection with 5 mL saline solution will be administered under the same sterile and ultrasound-guided conditions.
The syringe's outer part will be covered by an independent researcher to conceal the contents.
All participants will also perform a home exercise program: quadriceps strengthening and knee isometric exercises. Receives: Procedure: Placebo injection (normal saline) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect on gait kinematics
Change in gait and pressure parameters measured with the DIERS Formetric 4D analysis system.
Measured: 4 weeks
1. 6 minute walk test
It is a test used to assess the level of functional exercise or functional capacity. The patient is asked to walk, but not run, in a 25 m long corridor at the highest possible speed without stopping. At the end of 6 minutes, the number of metres walked by the patient is recorded. The 6 min walk test is an evaluation criterion used in routine and clinical research to assess functional capacity in many diseases such as heart failure, general arthrosis, multiple sclerosis.
Measured: 4 weeks
Secondary outcomes (2)
(VAS) for pain and fatigue
Severity of pain that the participants have had in the past week was evaluated by using visual analogue scale (VAS) on a 10-cm horizontal line where 0-cm represented "no pain" and 10 cm the "worst imaginable pain" Severity of fatigue experienced by the participants in the past week was assessed by using VAS on a 10-cm horizontal line where 0-cm represented "not tired at all" and 10-cm "extremely tired"
Measured: 4 weeks
WOMAC
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a valid and reliable questionnaire frequently used in clinical and research settings for patients with knee osteoarthritis. It consists of 24 questions and includes three subcategories: pain, stiffness, and physical function. The patient fills out the questionnaire themselves. The pain subcategory is assessed with five questions, stiffness with two questions, and physical function with 17 questions. Each question is scored according to a Likert scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe. The subcategories are evaluated independently. Higher scores on the questionnaire indicate a greater degree of disability.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start1 Feb 2026
- Primary completion30 Aug 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gonarthrosis; PrimaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ece Cinar, Ege University
- Investigators
- Ece Cinar, Assistant Professor, Principal investigator, EGE UNİVERCİTY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07326098
- Sponsor's protocol ID
- 25-5.1/20
- Status last verified
- Apr 2026
- First submitted
- 25 Dec 2025
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lebleu J, Fonkoue L, Bandolo E, Fossoh H, Mahaudens P, Cornu O, Detrembleur C. Lower limb kinematics improvement after genicular nerve blockade in patients with knee osteoarthritis: a milestone study using inertial sensors. BMC Musculoskelet Disord. 2020 Dec 7;21(1):822. doi: 10.1186/s12891-020-03836-8.
PubMed 33287783