Gonarthrosis; PrimaryGNB-KOA-RCTNCT07174167
Genicular Nerve Block in Chronic Knee Osteoarthritis
A study testing Genicular nerve block with prilocaine and genicular nerve block with prilocaine and triamcinolone in people with Gonarthrosis; Primary and Genicular Nerve Block, run by Haydarpasa Numune Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to evaluate whether genicular nerve block (GNB) is effective in reducing pain in patients with knee osteoarthritis. It will also assess the comparative efficacy of different injection protocols. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Gonarthrosis; Primary, Genicular Nerve Block, Gonarthritis
- What is being tested?
- Genicular nerve block with prilocaine and genicular nerve block with prilocaine and triamcinolone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2023to 1 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age between 45 and 75
- diagnosed with knee osteoarthritis (OA) according to the American College of Rheumatology (ACR) criteria
- possessing a Kellgren-Lawrence radiological grade of 2-3
Who cannot join
- any joint injection to the target knee in the past 3 months
- physical therapy for the target knee within the last 3 months
- previous knee surgery
- inflammatory rheumatic diseases
- active lumbar radiculopathy on the same side
- neurological disorders (e.g., Alzheimer's or dementia)
Show all 11Show fewer
- uncontrolled cardiopulmonary diseases
- pregnancy or lactation
- obesity (body mass index [BMI] >35)
- presence of a pacemaker
- active malignancy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Haydarpasa Numune Training and Research Hospital
Istanbul
About this study
Official title: Effectiveness of Genicular Nerve Block on Pain and Disability in Chronic Knee Osteoarthritis: A Randomized Controlled Trial
The goal of this clinical trial is to evaluate whether genicular nerve block (GNB) is effective in reducing pain in patients with knee osteoarthritis. It will also assess the comparative efficacy of different injection protocols.
The main questions it aims to answer are:
Read more
Does genicular nerve block with corticosteroid and local anesthetic provide superior pain relief compared with local anesthetic alone or placebo?
Are there differences in clinical outcomes between the three treatment groups?
Researchers will compare three groups:
GNB with corticosteroid plus local anesthetic
GNB with local anesthetic alone
Sham procedure with saline (placebo control)
Participants will:
Receive the assigned injection protocol in accordance with their group
Be evaluated at baseline and scheduled follow-up visits for pain intensity and functional status
Report their pain scores and functional limitations using standardized assessment tools
- Conditions
- Gonarthrosis; Primary, Genicular Nerve Block, Gonarthritis
- Being tested
- Genicular nerve block with prilocaine, genicular nerve block with prilocaine and triamcinolone, Sham injection
- Keywords
- genicular nerve block, knee osteoarthritis, pain, disability, gonarthrosis
- Medical subject headings
- Osteoarthritis, Knee, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genicular nerve block with prilocaineDrug
Also called group 1
ultrasound guided genicular nerve block (GNB) injecting 6 mL of 2% prilocaine to the genicular nerves
genicular nerve block with prilocaine and triamcinoloneDrug
Also called group 2
ultrasound guided genicular nerve block (GNB) injecting 5 mL of 2% prilocaine in combination with 1 mL/40 mg of triamcinolone to the genicular nerves
Sham injectionDrug
Also called group 3
placebo injection using 6 mL of 0.9% saline to knee region other than genicular nerves
| Study group | Role | What they receive |
|---|---|---|
| genicular nerve block with local anesthetic | Active comparator | Group 1 (GNB with local anesthetic only): Patients received a genicular nerve block (GNB) with 6 mL of 2% prilocaine and participated in a knee exercise program. Receives: Drug: Genicular nerve block with prilocaine |
| genicular nerve block with local anesthetic and corticosteroid | Active comparator | Group 2 (GNB with local anesthetic and corticosteroid): Patients received GNB with 5 mL of 2% prilocaine in combination with 1 mL/40 mg of triamcinolone and followed the same exercise regimen. Receives: Drug: genicular nerve block with prilocaine and triamcinolone |
| sham injection with saline | Sham comparator | Group 3 (Control group): Patients received a placebo injection (6 mL of 0.9% saline) with the knee exercise program. Receives: Drug: Sham injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Visual Analog Scale (VAS): The VAS assesses pain intensity on a 10-centimeter scale. Patients indicate their pain levels using two verbal descriptors at the end of each scale.
Measured: at baseline, 1 week, and 1 month after treatment
Secondary outcomes (3)
Functional status using WOMAC
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire assessed pain and disability.
Measured: baseline, 1 week, and 1 month after treatment
Functional status using 40-Meter Fast Walking Test
40-Meter Fast Walking Test: This test involved a designated 10-meter walking track. Patients walked at their maximum pace for four laps. No warm-up was conducted, and the time spent turning at the lines was excluded from the calculation
Measured: at baseline, 1 week, and 1 month after treatment
Pressure Pain Threshold (PPT)
Pressure Pain Threshold (PPT): The Commander Algometer (JTECH Medical, Utah, USA) was utilized to measure PPT at both the medial and lateral sides of the patella. The probe tip of the algometer was applied perpendicularly to the skin, and pressure was gradually increased. Patients indicated when they first experienced discomfort, at which point the measurement was recorded. This procedure was repeated three times, and the average value was noted.
Measured: baseline, 1 week, and 1 month after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start1 Apr 2023
- Primary completion10 Feb 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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, Investigator
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haydarpasa Numune Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berna Gunay, MD, Haydarpasa Numune Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07174167
- Sponsor's protocol ID
- KAEK 2023/58
- Acronym
- GNB-KOA-RCT
- Status last verified
- Nov 2025
- First submitted
- 2 Sep 2025
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The study data are available with the researcher and can be provided to the relevant authorities if required.
Publications
Li W, Xu F, Chen F, Cao L, Bao X. Effect of Genicular Nerve Block (GNB) on Pain in Lesions of the Knee Joint: A Meta-Analysis of Randomized Controlled Trials. J Pain Res. 2025 Jan 30;18:511-522. doi: 10.2147/JPR.S503937. eCollection 2025.
PubMed 39901967Kim DH, Lee MS, Lee S, Yoon SH, Shin JW, Choi SS. A Prospective Randomized Comparison of the Efficacy of Ultrasound- vs Fluoroscopy-Guided Genicular Nerve Block for Chronic Knee Osteoarthritis. Pain Physician. 2019 Mar;22(2):139-146.
PubMed 30921977Kim DH, Choi SS, Yoon SH, Lee SH, Seo DK, Lee IG, Choi WJ, Shin JW. Ultrasound-Guided Genicular Nerve Block for Knee Osteoarthritis: A Double-Blind, Randomized Controlled Trial of Local Anesthetic Alone or in Combination with Corticosteroid. Pain Physician. 2018 Jan;21(1):41-52.
PubMed 29357330Shanahan EM, Robinson L, Lyne S, Woodman R, Cai F, Dissanayake K, Paddick K, Cheung G, Voyvodic F. Genicular Nerve Block for Pain Management in Patients With Knee Osteoarthritis: A Randomized Placebo-Controlled Trial. Arthritis Rheumatol. 2023 Feb;75(2):201-209. doi: 10.1002/art.42384. Epub 2022 Nov 11.
PubMed 36369781
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Genicular Nerve Block on Pain and Disability in Chronic Knee Osteoarthritis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07174167
- Acronym / sponsor ID
- GNB-KOA-RCT / KAEK 2023/58
- Conditions
- Gonarthrosis; Primary, Genicular Nerve Block, Gonarthritis
- Keywords
- genicular nerve block, knee osteoarthritis, pain, disability, gonarthrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Haydarpasa Numune Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 10 Feb 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 15 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to evaluate whether genicular nerve block (GNB) is effective in reducing pain in patients with knee osteoarthritis. It will also assess the comparative efficacy of different injection protocols.
The main questions it aims to answer are:
Does genicular nerve block with corticosteroid and local anesthetic provide superior pain relief compared with local anesthetic alone or placebo?
Are there differences in clinical outcomes between the three treatment groups?
Researchers will compare three groups:
GNB with corticosteroid plus local anesthetic
GNB with local anesthetic alone
Sham procedure with saline (placebo control)
Participants will:
Receive the assigned injection protocol in accordance with their group
Be evaluated at baseline and scheduled follow-up visits for pain intensity and functional status
Report their pain scores and functional limitations using standardized assessment tools
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| genicular nerve block with local anesthetic | Active comparator | Drug: Genicular nerve block with prilocaineGroup 1 (GNB with local anesthetic only): Patients received a genicular nerve block (GNB) with 6 mL of 2% prilocaine and participated in a knee exercise program. |
| genicular nerve block with local anesthetic and corticosteroid | Active comparator | Drug: genicular nerve block with prilocaine and triamcinoloneGroup 2 (GNB with local anesthetic and corticosteroid): Patients received GNB with 5 mL of 2% prilocaine in combination with 1 mL/40 mg of triamcinolone and followed the same exercise regimen. |
| sham injection with saline | Sham comparator | Drug: Sham injectionGroup 3 (Control group): Patients received a placebo injection (6 mL of 0.9% saline) with the knee exercise program. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age between 45 and 75
- diagnosed with knee osteoarthritis (OA) according to the American College of Rheumatology (ACR) criteria
- possessing a Kellgren-Lawrence radiological grade of 2-3
Key exclusion criteria (11 listed)
- any joint injection to the target knee in the past 3 months
- physical therapy for the target knee within the last 3 months
- previous knee surgery
- inflammatory rheumatic diseases
- active lumbar radiculopathy on the same side
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Genicular nerve block with prilocaineAlso: group 1ultrasound guided genicular nerve block (GNB) injecting 6 mL of 2% prilocaine to the genicular nerves | Drug | genicular nerve block with local anesthetic |
| genicular nerve block with prilocaine and triamcinoloneAlso: group 2ultrasound guided genicular nerve block (GNB) injecting 5 mL of 2% prilocaine in combination with 1 mL/40 mg of triamcinolone to the genicular nerves | Drug | genicular nerve block with local anesthetic and corticosteroid |
| Sham injectionAlso: group 3placebo injection using 6 mL of 0.9% saline to knee region other than genicular nerves | Drug | sham injection with saline |
Primary outcome
Pain intensity
Time frame: at baseline, 1 week, and 1 month after treatment
Visual Analog Scale (VAS): The VAS assesses pain intensity on a 10-centimeter scale. Patients indicate their pain levels using two verbal descriptors at the end of each scale.
3 secondary outcomes
Functional status using WOMAC
Time frame: baseline, 1 week, and 1 month after treatment
Functional status using 40-Meter Fast Walking Test
Time frame: at baseline, 1 week, and 1 month after treatment
Pressure Pain Threshold (PPT)
Time frame: baseline, 1 week, and 1 month after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
- Background: PubMed 39901967Li W, Xu F, Chen F, Cao L, Bao X. Effect of Genicular Nerve Block (GNB) on Pain in Lesions of the Knee Joint: A Meta-Analysis of Randomized Controlled Trials. J Pain Res. 2025 Jan 30;18:511-522. doi: 10.2147/JPR.S503937. eCollection 2025.
- Background: PubMed 30921977Kim DH, Lee MS, Lee S, Yoon SH, Shin JW, Choi SS. A Prospective Randomized Comparison of the Efficacy of Ultrasound- vs Fluoroscopy-Guided Genicular Nerve Block for Chronic Knee Osteoarthritis. Pain Physician. 2019 Mar;22(2):139-146.
- Background: PubMed 29357330Kim DH, Choi SS, Yoon SH, Lee SH, Seo DK, Lee IG, Choi WJ, Shin JW. Ultrasound-Guided Genicular Nerve Block for Knee Osteoarthritis: A Double-Blind, Randomized Controlled Trial of Local Anesthetic Alone or in Combination with Corticosteroid. Pain Physician. 2018 Jan;21(1):41-52.
- Background: PubMed 36369781Shanahan EM, Robinson L, Lyne S, Woodman R, Cai F, Dissanayake K, Paddick K, Cheung G, Voyvodic F. Genicular Nerve Block for Pain Management in Patients With Knee Osteoarthritis: A Randomized Placebo-Controlled Trial. Arthritis Rheumatol. 2023 Feb;75(2):201-209. doi: 10.1002/art.42384. Epub 2022 Nov 11.
- Individual participant dataSharing planned: Undecided. The study data are available with the researcher and can be provided to the relevant authorities if required.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Genicular nerve block with prilocaine and genicular nerve block with prilocaine and triamcinolone in people with Gonarthrosis; Primary and Genicular Nerve Block, run by Haydarpasa Numune Training 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 3 inclusion and 11 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: finished, as of the sponsor's last update on 28 Nov 2025. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: at baseline, 1 week, and 1 month after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07174167, which also lists 4 linked publications.
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 28 Nov 2025.