Knee Arthritis OsteoarthritisNCT07781059
The Predictive Value of Ultrasonographic Quadriceps Muscle Parameters for Genicular Nerve Block Outcomes in Knee Osteoarthritis
An observational study of Knee Arthritis Osteoarthritis and Chronic Knee Pain, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this observational study is to learn whether thigh muscle structure can help predict pain relief after a genicular nerve block in people with knee osteoarthritis. A genicular nerve block is an injection used to reduce pain signals from the knee. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Knee Arthritis Osteoarthritis, Chronic Knee Pain
- What is being tested?
- genicular nerve block
- Type of treatment
- Surgery or procedure
- How many people
- 41 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2025to 1 Apr 2026
- Phase
- Observational
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults aged 50 to 80 years with unilateral chronic knee pain due to clinically and radiologically confirmed knee osteoarthritis. Participants had Kellgren-Lawrence grade 3 or 4 osteoarthritis, had not responded adequately to conservative treatments, and were already scheduled to undergo genicular nerve block as part of routine clinical care.
Who may be able to join
- Age between 50 and 80 years
- Unilateral symptomatic knee osteoarthritis
- Chronic knee pain for at least 3 months
- Clinical and radiographic confirmation of knee osteoarthritis
- Kellgren-Lawrence grade 3 or 4 knee osteoarthritis
- Inadequate clinical response despite analgesic therapy and physical therapy
- Clinical indication for genicular nerve block
Who cannot join
- History of surgery involving the knee region
- Bilateral symptomatic knee osteoarthritis
- Intra-articular knee injection within the previous 3 months
- Systemic disease that could affect study assessments
- Systemic or local infection
- Coagulation disorder
- Failure to provide written informed consent
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University Pendik Training and Research Hospital
Istanbul, Pendik, 34899
About this study
Official title: The Role of Quadriceps Muscle Architecture Parameters in Predicting the Success of Genicular Nerve Block in Patients With Chronic Knee Osteoarthritis Pain
The goal of this observational study is to learn whether thigh muscle structure can help predict pain relief after a genicular nerve block in people with knee osteoarthritis. A genicular nerve block is an injection used to reduce pain signals from the knee.
The main questions are:
Read more
- Are muscle thickness, fiber length, and fiber angle linked to pain relief after the procedure?
- Are these muscle measurements linked to changes in physical function and quality of life?
Participants are adults aged 50 to 80 with long-term pain from osteoarthritis in one knee. They are already scheduled to receive a genicular nerve block as part of their regular medical care. The study does not assign participants to receive this procedure.
Before the procedure, researchers will use ultrasound to measure the vastus lateralis muscle in the thigh. Participants will also answer questions about pain, daily function, and quality of life. Researchers will repeat these assessments after 1 hour, 3 weeks, and 3 months. Pain relief will be considered successful when pain is at least half as severe as it was before the procedure.
- Conditions
- Knee Arthritis Osteoarthritis, Chronic Knee Pain
- Being tested
- genicular nerve block
- Keywords
- knee osteoartritis, genicular nerve block, quadriceps muscle architecture, ultrasound -guided, pain management, WOMAC, EQ-5D, Numeric Rating Scale
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
genicular nerve blockProcedure or surgery
Ultrasound-guided genicular nerve block targeting the superomedial, superolateral, and inferomedial genicular nerves was performed as part of routine clinical management for chronic knee osteoarthritis.
| Study group | Role | What they receive |
|---|---|---|
| Patients With Chronic Knee Osteoarthritis Undergoing Ultrasound- Guided Genicular Nerve Block | Not described Receives: Procedure: genicular nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Intensity Assessed by the Numeric Rating Scale (NRS)
Pain intensity will be assessed using an 11-point Numeric Rating Scale ranging from 0 (no pain) to 10 (worst imaginable pain). Changes from baseline will be evaluated following ultrasound-guided genicular nerve block. Lower scores indicate lower pain intensity.
Measured: Baseline , 3 weeks, and 3 months
Secondary outcomes (5)
Baseline Vastus Lateralis Muscle Thickness
Vastus lateralis muscle thickness assessed by ultrasound and recorded in millimeters (mm).
Measured: Baseline
Baseline Vastus Lateralis Pennation Angle
Description: Vastus lateralis pennation angle assessed by ultrasound and recorded in degrees (°).
Measured: Baseline
Baseline Vastus Lateralis Fascicle Length
Description: Vastus lateralis fascicle length assessed by ultrasound and recorded in millimeters (mm).
Measured: Baseline
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score
Description: Pain, stiffness, and physical function related to knee osteoarthritis will be assessed using the 24-item WOMAC questionnaire. The total score ranges from 0 to 96, with higher scores indicating greater pain, stiffness, and functional impairment. Changes from baseline will be evaluated following ultrasound-guided genicular nerve block.
Measured: Baseline, 3 weeks, and 3 months after the procedure
Change in Health-Related Quality of Life Assessed by the EQ-5D
Description: Health-related quality of life will be assessed using the EQ-5D questionnaire. Responses will be converted into an EQ-5D index score, where higher scores indicate better health status. A score of 1 represents full health, 0 represents a health state equivalent to death, and negative scores represent health states considered worse than death. Changes from baseline will be evaluated following ultrasound-guided genicular nerve block.
Measured: Baseline, 3 weeks, and 3 months after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start1 Jun 2025
- Primary completion1 Apr 2026
- Study completion1 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Arthritis OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07781059
- Sponsor's protocol ID
- 09.2019.1051
- Status last verified
- Jun 2025
- First submitted
- 17 Aug 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Quadriceps Muscle Architecture Parameters in Predicting the Success of Genicular Nerve Block in Patients With Chronic Knee Osteoarthritis Pain
- ClinicalTrials.gov ID
- NCT07781059
- Acronym / sponsor ID
- 09.2019.1051
- Conditions
- Knee Arthritis Osteoarthritis, Chronic Knee Pain
- Keywords
- knee osteoartritis, genicular nerve block, quadriceps muscle architecture, ultrasound -guided, pain management, WOMAC, EQ-5D, Numeric Rating Scale
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 1 Apr 2026 (actual)
- First posted
- 24 Aug 2026 (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 observational study is to learn whether thigh muscle structure can help predict pain relief after a genicular nerve block in people with knee osteoarthritis. A genicular nerve block is an injection used to reduce pain signals from the knee.
The main questions are:
- Are muscle thickness, fiber length, and fiber angle linked to pain relief after the procedure?
- Are these muscle measurements linked to changes in physical function and quality of life?
Participants are adults aged 50 to 80 with long-term pain from osteoarthritis in one knee. They are already scheduled to receive a genicular nerve block as part of their regular medical care. The study does not assign participants to receive this procedure.
Before the procedure, researchers will use ultrasound to measure the vastus lateralis muscle in the thigh. Participants will also answer questions about pain, daily function, and quality of life. Researchers will repeat these assessments after 1 hour, 3 weeks, and 3 months. Pain relief will be considered successful when pain is at least half as severe as it was before the procedure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients With Chronic Knee Osteoarthritis Undergoing Ultrasound- Guided Genicular Nerve Block | – | Procedure: genicular nerve block |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged 50 to 80 years with unilateral chronic knee pain due to clinically and radiologically confirmed knee osteoarthritis. Participants had Kellgren-Lawrence grade 3 or 4 osteoarthritis, had not responded adequately to conservative treatments, and were already scheduled to undergo genicular nerve block as part of routine clinical care.
Key inclusion criteria (7 listed)
- Age between 50 and 80 years
- Unilateral symptomatic knee osteoarthritis
- Chronic knee pain for at least 3 months
- Clinical and radiographic confirmation of knee osteoarthritis
- Kellgren-Lawrence grade 3 or 4 knee osteoarthritis
Key exclusion criteria (7 listed)
- History of surgery involving the knee region
- Bilateral symptomatic knee osteoarthritis
- Intra-articular knee injection within the previous 3 months
- Systemic disease that could affect study assessments
- Systemic or local infection
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 blockUltrasound-guided genicular nerve block targeting the superomedial, superolateral, and inferomedial genicular nerves was performed as part of routine clinical management for chronic knee osteoarthritis. | Procedure or surgery | Patients With Chronic Knee Osteoarthritis Undergoing Ultrasound- Guided Genicular Nerve Block |
Primary outcome
Change in Pain Intensity Assessed by the Numeric Rating Scale (NRS)
Time frame: Baseline , 3 weeks, and 3 months
Pain intensity will be assessed using an 11-point Numeric Rating Scale ranging from 0 (no pain) to 10 (worst imaginable pain). Changes from baseline will be evaluated following ultrasound-guided genicular nerve block. Lower scores indicate lower pain intensity.
5 secondary outcomes
Baseline Vastus Lateralis Muscle Thickness
Time frame: Baseline
Baseline Vastus Lateralis Pennation Angle
Time frame: Baseline
Baseline Vastus Lateralis Fascicle Length
Time frame: Baseline
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score
Time frame: Baseline, 3 weeks, and 3 months after the procedure
Change in Health-Related Quality of Life Assessed by the EQ-5D
Time frame: Baseline, 3 weeks, and 3 months after the procedure
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 24 Aug 2026.
- Individual participant dataSharing planned: No
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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?
An observational study of Knee Arthritis Osteoarthritis and Chronic Knee Pain, run by Marmara University 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 7 inclusion and 7 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 24 Aug 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?
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?
Change in Pain Intensity Assessed by the Numeric Rating Scale (NRS) (time frame: Baseline , 3 weeks, and 3 months). 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 24 Aug 2026.