Osteoarthritis, KneeNCT05447624
The Effect of Radiofrequency Ablation on the Results of the Genicular Nerve Number in the Treatment of Knee Osteoarthritis
A study testing Radiofrequency ablation of genicular nerves in people with Osteoarthritis, Knee and Radiofrequency Ablation, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
Knee osteoarthritis is a disease that increases in frequency with age and decreases the quality of life and physical activity by leading to a decrease in pain and joint range of motion. Basically, the articular cartilage is affected and clinically pain, joint stiffness, crepitation and effusion are seen. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Osteoarthritis, Knee, Radiofrequency Ablation, Genicular Nerve
- What is being tested?
- Radiofrequency ablation of genicular nerves
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2022to 2 Oct 2022
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be over 50 years old and under 80 years old
- Symptom duration is at least 3 months
- Pre-procedure NRS score of more than 6
- Kellgren-Lawrence stage 3-4
- Failure to respond to conservative treatments
- Having given consent to participate in the study
- The patient's ability to speak and read and write Turkish
Who cannot join
- Body mass index of 41 kg/m2 or more
- Acute knee injury
- Chronic pain syndrome (fibromyalgia syndrome, chronic fatigue syndrome, etc.)
- Lumbar radicular pain
- Uncontrolled diabetes mellitus
- Presence of bleeding diathesis
Show all 14Show fewer
- Hemodynamic instability
- Pacemaker presence
- History of septic arthritis or active local or systemic infection
- Having a history of surgery on the knee to be treated
- Intra-articular injection of the knee within 3 months
- Cognitive impairment
- Presence of genu valgus deformity
- Presence of secondary knee osteoarthritis (due to trauma, rheumatoid arthritis, systemic inflammatory diseases such as gout, kinetic chain disorder due to congenital hip dislocation)
Trial locations and contacts
1 site in 1 country.
About this study
Knee osteoarthritis is a disease that increases in frequency with age and decreases the quality of life and physical activity by leading to a decrease in pain and joint range of motion. Basically, the articular cartilage is affected and clinically pain, joint stiffness, crepitation and effusion are seen. In imaging techniques applied with weight-bearing, varying degrees of joint narrowing are observed, although it is more common in the medial. Treatment options include conservative approaches such as weight loss, physical therapy, analgesics, or invasive approaches such as intra-articular injections, peripheral nerve blocks, joint-sparing surgery or total knee replacement. Surgical operation should be considered in the treatment when conservative treatments are insufficient. However, the advanced age of this patient group and the large number of comorbidities reduce the possibility of surgical operation. Although treatment cannot be cured in knee osteoarthritis, the aim of the treatment is to decrease the pain, increase the patient's quality of life and physical capacity, and slow down the progression of the disease.
Although the radiofrequency ablation (RFA) technique has been used since the 1970s, the first application area was trigeminal neuralgia. Later, its use in neck and back pain became widespread, but the first randomized controlled study on its use in knee osteoarthritis was Choi et al. Made by in 2011. The purpose of radiofrequency ablation applied to the genicular nerves that receive the sensation of the knee joint capsule is to prevent sensory transmission and reduce the sensation of pain by creating axonal damage to these nerves. Since the use of RFA in knee osteoarthritis is relatively new, studies on the development of the technique continue. Fluoroscopy device or ultrasonography can be used as imaging method to show target nerves or to place the RFA electrode in the correct localization.
The investigators hypothesis; based on the more prominent medial involvement in knee osteoarthritis, the conventional RFA procedure applied to the 3 genicular nerves (SMGN, IMGN, SLGN) is not superior to the RFA procedure applied to the medial SMGN and IMGN branches.
- Being tested
- Radiofrequency ablation of genicular nerves
- Keywords
- Osteoarthritis Knee, Genicular Nerve, Radiofrequency Ablation
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency ablation of genicular nervesProcedure or surgery
The RF cannula will be placed near the nerve with an in-plane technique from proximal to distal. Sensory stimulation will be performed at 50 Hz to ensure localization. The sensory threshold should be less than 0.6 V. To prevent ablation of the motor nerves, when the nerve is stimulated with 2.0 V at 2 Hz, it will be seen that there is no fasciculation in the relevant region of the lower extremity. Before starting the ablation procedure, 2 mL of 1% lidocaine solution will be injected around the nerve, after vascularity control, in order to reduce the pain and the risk of neuritis during the procedure. Then the temperature will be adjusted to 80° degrees and applied for 90 seconds and the process will be terminated.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing ablation of two of the genicular nerve branches | Active comparator | Not described Receives: Procedure: Radiofrequency ablation of genicular nerves |
| Patients undergoing ablation of three of the genicular nerve branches | Active comparator | Not described Receives: Procedure: Radiofrequency ablation of genicular nerves |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Rating Scale
It is a scale on which patients score their pain between 0 and 10, with 0 = "no pain" and 10 = "worst pain imaginable"
Measured: 3 months
Secondary outcomes (4)
WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index)
WOMAC is a 24-item scale under the headings of pain, stiffness and functional activity. Patients rate the amount of strain, pain felt, and joint stiffness during daily activities between 0 and 4 (0 is the best, 4 is the worst), and the total score is between 0 and 96.
Measured: 3 months
SF-36 (Short Form-36)
SF-36 is a scale in which 8 sub-parameters such as physical function, body pain, and emotional well-being are evaluated with 36 questions.
Measured: 3 months
TUG (Timed Up and Go Test)
In the TUG test, the patient gets up from the chair with the command of the person performing the test, and after pressing the line drawn 3 meters on the floor with both feet before, he returns and sits on the chair. The tester measures the time elapsed between the stand up command and the patient's back contacting the chair. The patient can get support from the chair while getting up and sitting, and can rest whenever he wants, provided that he does not sit. During the test, the patient walks in the shoes he always uses and at his daily walking speed.
Measured: 3 months
use of analgesic drugs
During the follow-up period, the analgesic drugs used by the patients, if any, and the information about the use of these drugs during the follow-up period will be recorded.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start2 Jan 2022
- Primary completion2 Oct 2022
- Study completion2 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 42 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
- NCT05447624
- Sponsor's protocol ID
- 092021654
- Status last verified
- Oct 2022
- First submitted
- 1 Jul 2022
- Last updated
- 12 Oct 2022
- 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 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Radiofrequency Ablation on the Results of the Genicular Nerve Number in the Treatment of Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT05447624
- Acronym / sponsor ID
- 092021654
- Keywords
- Osteoarthritis Knee, Genicular Nerve, Radiofrequency Ablation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 2 Jan 2022 (actual)
- Primary completion
- 2 Oct 2022 (actual)
- Study completion
- 2 Oct 2022 (actual)
- First posted
- 7 Jul 2022 (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.
Knee osteoarthritis is a disease that increases in frequency with age and decreases the quality of life and physical activity by leading to a decrease in pain and joint range of motion. Basically, the articular cartilage is affected and clinically pain, joint stiffness, crepitation and effusion are seen. In imaging techniques applied with weight-bearing, varying degrees of joint narrowing are observed, although it is more common in the medial. Treatment options include conservative approaches such as weight loss, physical therapy, analgesics, or invasive approaches such as intra-articular injections, peripheral nerve blocks, joint-sparing surgery or total knee replacement. Surgical operation should be considered in the treatment when conservative treatments are insufficient. However, the advanced age of this patient group and the large number of comorbidities reduce the possibility of surgical operation. Although treatment cannot be cured in knee osteoarthritis, the aim of the treatment is to decrease the pain, increase the patient's quality of life and physical capacity, and slow down the progression of the disease.
Although the radiofrequency ablation (RFA) technique has been used since the 1970s, the first application area was trigeminal neuralgia. Later, its use in neck and back pain became widespread, but the first randomized controlled study on its use in knee osteoarthritis was Choi et al. Made by in 2011. The purpose of radiofrequency ablation applied to the genicular nerves that receive the sensation of the knee joint capsule is to prevent sensory transmission and reduce the sensation of pain by creating axonal damage to these nerves. Since the use of RFA in knee osteoarthritis is relatively new, studies on the development of the technique continue. Fluoroscopy device or ultrasonography can be used as imaging method to show target nerves or to place the RFA electrode in the correct localization.
The investigators hypothesis; based on the more prominent medial involvement in knee osteoarthritis, the conventional RFA procedure applied to the 3 genicular nerves (SMGN, IMGN, SLGN) is not superior to the RFA procedure applied to the medial SMGN and IMGN branches.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing ablation of two of the genicular nerve branches | Active comparator | Procedure: Radiofrequency ablation of genicular nerves |
| Patients undergoing ablation of three of the genicular nerve branches | Active comparator | Procedure: Radiofrequency ablation of genicular nerves |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Be over 50 years old and under 80 years old
- Symptom duration is at least 3 months
- Pre-procedure NRS score of more than 6
- Kellgren-Lawrence stage 3-4
- Failure to respond to conservative treatments
Key exclusion criteria (14 listed)
- Body mass index of 41 kg/m2 or more
- Acute knee injury
- Chronic pain syndrome (fibromyalgia syndrome, chronic fatigue syndrome, etc.)
- Lumbar radicular pain
- Uncontrolled diabetes mellitus
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 |
|---|---|---|
| Radiofrequency ablation of genicular nervesThe RF cannula will be placed near the nerve with an in-plane technique from proximal to distal. Sensory stimulation will be performed at 50 Hz to ensure localization. The sensory threshold should be less than 0.6 V. To prevent ablation of the motor nerves, when the nerve is stimulated with 2.0 V at 2 Hz, it will be seen that there is no fasciculation in the relevant region of the lower extremity. Before starting the ablation procedure, 2 mL of 1% lidocaine solution will be injected around the nerve, after vascularity control, in order to reduce the pain and the risk of neuritis during the procedure. Then the temperature will be adjusted to 80° degrees and applied for 90 seconds and the process will be terminated. | Procedure or surgery | Patients undergoing ablation of three of the genicular nerve branches, Patients undergoing ablation of two of the genicular nerve branches |
Primary outcome
Numeric Rating Scale
Time frame: 3 months
It is a scale on which patients score their pain between 0 and 10, with 0 = "no pain" and 10 = "worst pain imaginable"
4 secondary outcomes
WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index)
Time frame: 3 months
SF-36 (Short Form-36)
Time frame: 3 months
TUG (Timed Up and Go Test)
Time frame: 3 months
use of analgesic drugs
Time frame: 3 months
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 12 Oct 2022.
- 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?
A study testing Radiofrequency ablation of genicular nerves in people with Osteoarthritis, Knee and Radiofrequency Ablation, 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 14 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 12 Oct 2022. 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?
Numeric Rating Scale (time frame: 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 12 Oct 2022.