OsteoarthritisNCT06527651
Effects of Ultrasound-guided Genicular Nerve Block in Knee Osteoarthritis Patients on Proprioception and Static Balance
A study testing Genicular blocks (dexamethazone and lidocaine) in people with Osteoarthritis and Osteoarthritis, Knee, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
Genicular nerve block (GNB) is a novel and promising interventional method for pain in knee osteoarthritis (KOA). However ,it contains afferent fibers that receive impulses from proprioceptive and deep sensory receptors located in the joint capsule, ligaments, muscles, tendons and periosteum. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Osteoarthritis, Osteoarthritis, Knee, Proprioceptive Disorders
- What is being tested?
- Genicular blocks (dexamethazone and lidocaine)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2024to 14 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 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic knee pain more than >3 according to visual analog scale (VAS) and difficulty in function more than 3 months
- Grade 2-3 KOA according to the Kellgren -Lawrence radiological grading system
- No significant improvement in response to conservative treatments such as analgesics and physiotherapy.
Who cannot join
- History of trauma, fractures, malignencies, surgery and inflammatory diseases of knee
- Limitation of range of motion in unilaterally and/or bilaterally in knee joint
- Allergies of pharmacological agents using during procedure (lidocaine)
- Presence of intra-articular or peri-articular injection such as hyaluronic acids, corticosteroids or collagen supplements at last 6 months
- Other neurologic or rheumatological conditions that may lead vertigo or vestibular disfunction or presence of impairment in proprioception such as polineuropathy
- Presence of diabetes mellitus due to risk of small fiber neuropathy
- Cognitive impairment and uncontrolled systemic conditions.
Trial locations and contacts
1 site in 1 country.
About this study
Genicular nerve block (GNB) is a novel and promising interventional method for pain in knee osteoarthritis (KOA). However ,it contains afferent fibers that receive impulses from proprioceptive and deep sensory receptors located in the joint capsule, ligaments, muscles, tendons and periosteum. These proprioceptive stimuli are effective on joint position and biomechanics, protect the joint from injuries and help maintain balance. This study aims to evaluate Pproprioception and static balance after ultrasound-guided GNB in patients with knee osteoarthritis.
Read the detailed description
Genicular nerve block (GNB) is a novel and promising interventional method for pain in knee osteoarthritis (KOA). However ,it contains afferent fibers that receive impulses from proprioceptive and deep sensory receptors located in the joint capsule, ligaments, muscles, tendons and periosteum. These proprioceptive stimuli are effective on joint position and biomechanics, protect the joint from injuries and help maintain balance. This study aims to evaluate Pproprioception and static balance after ultrasound-guided GNB in patients with knee osteoarthritis.
- Being tested
- Genicular blocks (dexamethazone and lidocaine)
- Medical subject headings
- Osteoarthritis, Osteoarthritis, Knee, Somatosensory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genicular blocks (dexamethazone and lidocaine)Drug
Genicular blocks were applied bilaterally by another physiatrist who was experienced in ultrasonographic (US) interventional procedures more than 5 years. Total of 6mL solution consisting of 0.5 mg/2mL dexamethazone and 4mL %1 lidocaine for three branches of genicular nerves (superomedial, superolateral and inferomedial branches) was divided into three branches for each knee. Total of 12 mL solution was applied for each patient.
| Study group | Role | What they receive |
|---|---|---|
| Genicular blocks | Other | Genicular blocks were applied bilaterally by another physiatrist who was experienced in ultrasonographic (US) interventional procedures more than 5 years. Total of 6mL solution consisting of 0.5 mg/2mL dexamethazone and 4mL %1 lidocaine for three branches of genicular nerves (superomedial, superolateral and inferomedial branches) was divided into three branches for each knee. Total of 12 mL solution was applied for each patient. Antiseptic precautions were taken, sterile environment was prepared. A 5-12 MHz linear probe (Loqiq P5, GE Medical systems) was used for all US evaluations. The probe was positioned in line with the femur shaft. Firstly to find the superomedial genicular nerve, probe was moved to the junction of femur shaft and medial femoral condyle. Color doppler was used to clarify superomedial genicular artery and 2mL injection solution was applied around the pulsatile artery region. Receives: Drug: Genicular blocks (dexamethazone and lidocaine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog scale (VAS)
Ten-cm VAS was used as a self-report measure for knee joint pain. Turkish Validity and Reliability of scale was published. 0 indicates no pain and 10 indicates unbearable pain. As it approaches 10, the pain becomes more severe.
Measured: 24 hours
HUR SmartBalance®: HUR SmartBalance®
provides both balance assessments and rehabilitative training programs. Training programs are used in vertigo rehabilitation, balance training in mild gait disorders and fall prevention in elderly. Balance scores allow assessments and comparison in terms of static balance, proprioception disturbance, visual dependency and vestibular dominant proprioception . It consists of Balance Trainer, Support Rail, SmartBalance Software, Touchscreen Computer and Foam surface
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start1 Jun 2024
- Primary completion1 Jul 2024
- Study completion14 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06527651
- Sponsor's protocol ID
- 2
- Status last verified
- Jul 2024
- First submitted
- 16 Jul 2024
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Ultrasound-guided Genicular Nerve Block in Knee Osteoarthritis Patients on Proprioception and Static Balance
- ClinicalTrials.gov ID
- NCT06527651
- Acronym / sponsor ID
- 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 14 Jul 2024 (actual)
- First posted
- 30 Jul 2024 (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.
Genicular nerve block (GNB) is a novel and promising interventional method for pain in knee osteoarthritis (KOA). However ,it contains afferent fibers that receive impulses from proprioceptive and deep sensory receptors located in the joint capsule, ligaments, muscles, tendons and periosteum. These proprioceptive stimuli are effective on joint position and biomechanics, protect the joint from injuries and help maintain balance. This study aims to evaluate Pproprioception and static balance after ultrasound-guided GNB in patients with knee osteoarthritis.
Detailed description
Genicular nerve block (GNB) is a novel and promising interventional method for pain in knee osteoarthritis (KOA). However ,it contains afferent fibers that receive impulses from proprioceptive and deep sensory receptors located in the joint capsule, ligaments, muscles, tendons and periosteum. These proprioceptive stimuli are effective on joint position and biomechanics, protect the joint from injuries and help maintain balance. This study aims to evaluate Pproprioception and static balance after ultrasound-guided GNB in patients with knee osteoarthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Genicular blocks | Other | Drug: Genicular blocks (dexamethazone and lidocaine)Genicular blocks were applied bilaterally by another physiatrist who was experienced in ultrasonographic (US) interventional procedures more than 5 years. Total of 6mL solution consisting of 0.5 mg/2mL dexamethazone and 4mL %1 lidocaine for three branches of genicular nerves (superomedial, superolateral and inferomedial branches) was divided into three branches for each knee. Total of 12 mL solution was applied for each patient. Antiseptic precautions were taken, sterile environment was prepared. A 5-12 MHz linear probe (Loqiq P5, GE Medical systems) was used for all US evaluations. The probe was positioned in line with the femur shaft. Firstly to find the superomedial genicular nerve, probe was moved to the junction of femur shaft and medial femoral condyle. Color doppler was used to clarify superomedial genicular artery and 2mL injection solution was applied around the pulsatile artery region. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Chronic knee pain more than >3 according to visual analog scale (VAS) and difficulty in function more than 3 months
- Grade 2-3 KOA according to the Kellgren -Lawrence radiological grading system
- No significant improvement in response to conservative treatments such as analgesics and physiotherapy.
Key exclusion criteria (7 listed)
- History of trauma, fractures, malignencies, surgery and inflammatory diseases of knee
- Limitation of range of motion in unilaterally and/or bilaterally in knee joint
- Allergies of pharmacological agents using during procedure (lidocaine)
- Presence of intra-articular or peri-articular injection such as hyaluronic acids, corticosteroids or collagen supplements at last 6 months
- Other neurologic or rheumatological conditions that may lead vertigo or vestibular disfunction or presence of impairment in proprioception such as polineuropathy
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 blocks (dexamethazone and lidocaine)Genicular blocks were applied bilaterally by another physiatrist who was experienced in ultrasonographic (US) interventional procedures more than 5 years. Total of 6mL solution consisting of 0.5 mg/2mL dexamethazone and 4mL %1 lidocaine for three branches of genicular nerves (superomedial, superolateral and inferomedial branches) was divided into three branches for each knee. Total of 12 mL solution was applied for each patient. | Drug | Genicular blocks |
Primary outcome
Visual analog scale (VAS)
Time frame: 24 hours
Ten-cm VAS was used as a self-report measure for knee joint pain. Turkish Validity and Reliability of scale was published. 0 indicates no pain and 10 indicates unbearable pain. As it approaches 10, the pain becomes more severe.
HUR SmartBalance®: HUR SmartBalance®
Time frame: 24 hours
provides both balance assessments and rehabilitative training programs. Training programs are used in vertigo rehabilitation, balance training in mild gait disorders and fall prevention in elderly. Balance scores allow assessments and comparison in terms of static balance, proprioception disturbance, visual dependency and vestibular dominant proprioception . It consists of Balance Trainer, Support Rail, SmartBalance Software, Touchscreen Computer and Foam surface
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 30 Jul 2024.
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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 blocks (dexamethazone and lidocaine) in people with Osteoarthritis and Osteoarthritis, Knee, run by Ankara City Hospital Bilkent 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 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 30 Jul 2024. 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?
Visual analog scale (VAS) (time frame: 24 hours). 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 30 Jul 2024.