- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07326098
Efficacy of Ultrasound-Guided Genicular Nerve Block in Patients With Gonarthrosis: A Randomized, Placebo-Controlled, Double-Blind 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.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Izmir, Turkey (Türkiye), 35100
- Ege University Faculty of Medicine
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BORNOVA
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Izmir, BORNOVA, Turkey (Türkiye), 35100
- Ege University Faculty of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: İntervention group
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. |
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.
Other Names:
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Placebo Comparator: Placebo group
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. |
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Effect on gait kinematics
Time Frame: 4 weeks
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Change in gait and pressure parameters measured with the DIERS Formetric 4D analysis system.
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4 weeks
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1. 6 minute walk test
Time Frame: 4 weeks
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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.
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4 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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(VAS) for pain and fatigue
Time Frame: 4 weeks
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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"
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4 weeks
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WOMAC
Time Frame: 4 weeks
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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.
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4 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ece Cinar, Assistant Professor, EGE UNİVERCİTY
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 25-5.1/20
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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