Radiofrequency AblationpainNCT07113028
Comparison of the Effectiveness of Conventional and Pulse Radiofrequency Therapy in Advanced Knee Osteoarthritis in Elderly Patients: An Observational Study
An observational study of Radiofrequency Ablation and Knee Arthritis Osteoarthritis, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Knee osteoarthritis (OA) is a very common joint disease, causing pain and loss of function. Osteoarthritis, including knee OA, is a significant cause of morbidity and disability in older adults and negatively impacts the functionality of individuals over the age of 65. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Radiofrequency Ablation, Knee Arthritis Osteoarthritis
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2025to 1 Sep 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: The study will include 60 patients aged 45 years and over, diagnosed with Kellgren-Lawrence (KL) stage 3-4 knee osteoarthritis, who underwent ultrasound-guided geniculate radiofrequency (RFT) between January 2022 and January 2023 at the Algology Department of Kanuni Sultan Süleyman Training and Research Hospital. The minimum number of patients required to achieve a 10% difference (normal width = 4.5 + 0.4 mm), i.e., a difference of approximately 0.5 mm, was determined to be 30 (80% power, p<0.05). Considering the losses, the planned inclusion of 60 patients is planned.
Who may be able to join
- Patients who have undergone ultrasound-guided genicular nerve RFT.
- Patients over the age of 65 who have a diagnosis of knee OA and who cannot achieve adequate pain palliation with conservative treatments.
- Patients with complete data to be scanned in their files.
- Exclusion Criteria:-Patients who have received radiofrequency treatments other than those diagnosed with osteoarthritis
- Patients who have received intra-articular knee injections, PRP, or hyaluronic acid injections in the last 6 months
- Patients who have undergone knee replacement surgery
Show all 12Show fewer
- Patients diagnosed with malignancy
- Patients who have received steroids for any reason in the last 6 months
- Patients with radicular pain
- Connective tissue diseases
- Serious neurological or psychiatric disorders
- Mental impairment that prevents adequate communication or cooperation Use of anticoagulant medications
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kanuni Sultan Süleyman Training and Research Hospital
Küçükçekmece, Istanbul, (507) 277-4773
About this study
Knee osteoarthritis (OA) is a very common joint disease, causing pain and loss of function. Osteoarthritis, including knee OA, is a significant cause of morbidity and disability in older adults and negatively impacts the functionality of individuals over the age of 65. When non-invasive treatments such as medical therapy, physical therapy, and rehabilitation fail to provide adequate pain control, intra-articular injections, geniculate nerve blocks, radiofrequency ablation, and surgical treatments are considered.
Genicular nerve blocks provide short-term pain relief in knee osteoarthritis . Despite various conservative treatments, many patients with chronic knee OA experience severe knee pain before total knee arthroplasty. Genicular nerve block (GNB) and radiofrequency ablation of the geniculate nerves have been shown to be effective in relieving pain and improving knee functionality in patients with chronic knee OA. Intra-articular corticosteroids are used in the treatment of knee OA to rapidly relieve pain, reduce pain within the first three months, and rapidly restore joint function . Both conventional and pulsed radiofrequency treatments have been effective in relieving pain and improving disability in patients with knee OA who have not responded to conservative treatment and have contraindications for surgery. Conventional radiofrequency therapy uses high-frequency alternating current to create thermal lesions. The thermal energy creates a zone of coagulative necrosis that includes the nerves that transmit and/or modulate pain sensation . In pulsed radiofrequency therapy, thermal tissue damage can be minimized by using pulsed high-voltage radiofrequency currents. This allows time for the heat to dissipate and generally maintains the tissue temperature near the electrode below the neurodestructive range. The mechanism by which pulsed radiofrequency provides clinical benefit is not fully understood. It appears to modulate signaling cascades, particularly in C fibers, without affecting nerve conduction in myelinated fibers . As an alternative to the thermal effects of conventional radiofrequency therapy, pulsed radiofrequency therapy has been noted to have fewer potential side effects .
In conclusion, the therapeutic effects of radiofrequency applications on improving pain and functional impairments due to knee osteoarthritis (KOA) have been demonstrated; however, the number of studies evaluating only elderly patients (aged 65 and over) is limited. Studies comparing conventional and pulsed radiofrequency treatments of the genicular nerves and evaluating their effects on geriatric parameters are limited. The primary objective of our study was to compare the effects of conventional and pulsed radiofrequency treatments of the genicular nerves under ultrasound guidance on knee pain and functional assessments in elderly patients, and the secondary objective was to determine their effects on geriatric assessments.
Read the detailed description
The study will be conducted at the Department of Algology at Kanuni Sultan Süleyman Training and Research Hospital by retrospectively reviewing the medical records of patients aged 65 and over diagnosed with knee osteoarthritis who underwent conventional or pulsed radiofrequency (USG)-guided radiofrequency (RF) treatment of the genicular nerves between January 2023 and March 2024. The interventional procedure is performed under sterile conditions, with the patient monitored, supported below the knee, and in slight flexion, adhering to asepsis and antisepsis guidelines. The genicular nerves are visualized using ultrasound guidance, and radiofrequency treatment is administered in conventional or pulsed mode, followed by appropriate sensory and motor stimuli. Demographic data, height, weight, duration of symptoms, comorbidities, analgesic use, pre-treatment and post-treatment 1st and 3rd month Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Numeric Rating Scale-11 (NRS-11), Tinneti Balance, Tinneti gait and performance-oriented mobility assessment (POMA), and timed up and go test will be recorded from the patient files.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Comparison of the Effectiveness of Conventional and Pulsed Radiofrequency Treatment in Advanced Knee | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Rating Scale-11 (NRS-11): This is an 11-point scale used to describe pain. It is based solely on the patient's ability to perform activities of daily living and can be used for adults and children ages 10 and older.
Measured: 1 month
Secondary outcomes (1)
Western Ontario and McMaster Universities. Higher scores indicate worse pain, stiffness, and functional limitations. The WOMAC consists of five items for pain (score range 0-20), two items for stiffness (score range 0-8), and 17 items for functional limi
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start1 Aug 2025
- Primary completion30 Aug 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiofrequency AblationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Halil Ibrahim Altun, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07113028
- Sponsor's protocol ID
- Radiofrequency, knee pain
- Acronym
- pain
- Status last verified
- Aug 2025
- First submitted
- 1 Aug 2025
- Last updated
- 8 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Conventional and Pulse Radiofrequency Therapy in Advanced Knee Osteoarthritis in Elderly Patients: An Observational Study
- ClinicalTrials.gov ID
- NCT07113028
- Acronym / sponsor ID
- pain / Radiofrequency, knee pain
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 30 Aug 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 8 Aug 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.
Knee osteoarthritis (OA) is a very common joint disease, causing pain and loss of function. Osteoarthritis, including knee OA, is a significant cause of morbidity and disability in older adults and negatively impacts the functionality of individuals over the age of 65. When non-invasive treatments such as medical therapy, physical therapy, and rehabilitation fail to provide adequate pain control, intra-articular injections, geniculate nerve blocks, radiofrequency ablation, and surgical treatments are considered.
Genicular nerve blocks provide short-term pain relief in knee osteoarthritis . Despite various conservative treatments, many patients with chronic knee OA experience severe knee pain before total knee arthroplasty. Genicular nerve block (GNB) and radiofrequency ablation of the geniculate nerves have been shown to be effective in relieving pain and improving knee functionality in patients with chronic knee OA. Intra-articular corticosteroids are used in the treatment of knee OA to rapidly relieve pain, reduce pain within the first three months, and rapidly restore joint function . Both conventional and pulsed radiofrequency treatments have been effective in relieving pain and improving disability in patients with knee OA who have not responded to conservative treatment and have contraindications for surgery. Conventional radiofrequency therapy uses high-frequency alternating current to create thermal lesions. The thermal energy creates a zone of coagulative necrosis that includes the nerves that transmit and/or modulate pain sensation . In pulsed radiofrequency therapy, thermal tissue damage can be minimized by using pulsed high-voltage radiofrequency currents. This allows time for the heat to dissipate and generally maintains the tissue temperature near the electrode below the neurodestructive range. The mechanism by which pulsed radiofrequency provides clinical benefit is not fully understood. It appears to modulate signaling cascades, particularly in C fibers, without affecting nerve conduction in myelinated fibers . As an alternative to the thermal effects of conventional radiofrequency therapy, pulsed radiofrequency therapy has been noted to have fewer potential side effects .
In conclusion, the therapeutic effects of radiofrequency applications on improving pain and functional impairments due to knee osteoarthritis (KOA) have been demonstrated; however, the number of studies evaluating only elderly patients (aged 65 and over) is limited. Studies comparing conventional and pulsed radiofrequency treatments of the genicular nerves and evaluating their effects on geriatric parameters are limited. The primary objective of our study was to compare the effects of conventional and pulsed radiofrequency treatments of the genicular nerves under ultrasound guidance on knee pain and functional assessments in elderly patients, and the secondary objective was to determine their effects on geriatric assessments.
Detailed description
The study will be conducted at the Department of Algology at Kanuni Sultan Süleyman Training and Research Hospital by retrospectively reviewing the medical records of patients aged 65 and over diagnosed with knee osteoarthritis who underwent conventional or pulsed radiofrequency (USG)-guided radiofrequency (RF) treatment of the genicular nerves between January 2023 and March 2024. The interventional procedure is performed under sterile conditions, with the patient monitored, supported below the knee, and in slight flexion, adhering to asepsis and antisepsis guidelines. The genicular nerves are visualized using ultrasound guidance, and radiofrequency treatment is administered in conventional or pulsed mode, followed by appropriate sensory and motor stimuli. Demographic data, height, weight, duration of symptoms, comorbidities, analgesic use, pre-treatment and post-treatment 1st and 3rd month Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Numeric Rating Scale-11 (NRS-11), Tinneti Balance, Tinneti gait and performance-oriented mobility assessment (POMA), and timed up and go test will be recorded from the patient files.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Comparison of the Effectiveness of Conventional and Pulsed Radiofrequency Treatment in Advanced Knee | – | – |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- The study will include 60 patients aged 45 years and over, diagnosed with Kellgren-Lawrence (KL) stage 3-4 knee osteoarthritis, who underwent ultrasound-guided geniculate radiofrequency (RFT) between January 2022 and January 2023 at the Algology Department of Kanuni Sultan Süleyman Training and Research Hospital. The minimum number of patients required to achieve a 10% difference (normal width = 4.5 + 0.4 mm), i.e., a difference of approximately 0.5 mm, was determined to be 30 (80% power, p<0.05). Considering the losses, the planned inclusion of 60 patients is planned.
Key inclusion criteria (12 listed)
- Patients who have undergone ultrasound-guided genicular nerve RFT.
- Patients over the age of 65 who have a diagnosis of knee OA and who cannot achieve adequate pain palliation with conservative treatments.
- Patients with complete data to be scanned in their files.
- Exclusion Criteria:-Patients who have received radiofrequency treatments other than those diagnosed with osteoarthritis
- Patients who have received intra-articular knee injections, PRP, or hyaluronic acid injections in the last 6 months
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Numeric Rating Scale-11 (NRS-11): This is an 11-point scale used to describe pain. It is based solely on the patient's ability to perform activities of daily living and can be used for adults and children ages 10 and older.
Time frame: 1 month
1 secondary outcome
Western Ontario and McMaster Universities. Higher scores indicate worse pain, stiffness, and functional limitations. The WOMAC consists of five items for pain (score range 0-20), two items for stiffness (score range 0-8), and 17 items for functional limi
Time frame: 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Radiofrequency Ablation
Active, not recruiting
Prospective Study of TVRFA Treatment for FIGO Type 3-5 Uterine Fibroids
Leiomyoma (Uterine Fibroids)
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
Not yet recruitingObservational study
Observation Study on the Efficacy and Safety of Hepatic Artery Embolization Combined With Radiofrequency Ablation for Hepatic Hemangioma: The Impact of Different Treatment Intervals
Hepatic Hemangioma
Not yet recruitingObservational study
Endoscopic Papillectomy Versus Surgery for Ampullary Tumors: A Prospective Multicenter Cohort Study
Ampullary Neoplasm, Ampullary Adenoma
RecruitingObservational study
Novel Bipolar Radiofrequency Ablation Knife in Esophageal Lesions
Esophageal Neoplasm, Esophageal Polyp
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 Radiofrequency Ablation and Knee Arthritis Osteoarthritis, run by Kanuni Sultan Suleyman 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 12 inclusion and 0 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: under way, not looking for participants, as of the sponsor's last update on 8 Aug 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. 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?
This study is still under way. Results are not available in the source record yet.
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-11 (NRS-11): This is an 11-point scale used to describe pain. It is based solely on the patient's ability to perform activities of daily living and can be used for adults and children ages 10 and older. (time frame: 1 month). 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 8 Aug 2025.