Knee OsteoarthritisNCT06863181
Comparison of Conventional and Cooled Radiofrequency Ablation in Knee Osteoarthritis
A study testing Radiofrequency ablation in people with Knee Osteoarthritis, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to examine and compare the effects of conventional and cooled radiofrequency ablation on pain and disability levels in patients with knee pain resistant to other treatments due to knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Radiofrequency ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2025to 12 Nov 2025
- 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
- Knee pain lasting more than 6 months
- Age between 50 and 80
- Diagnosis of radiographically proven grade III or IV knee osteoarthritis according to the Kellgren-Lawrence Grading Scale, marked narrowing of the medial compartment of the tibiofemoral joint space
- Presence of pain resistant to conservative treatment
- Exercise
- Physical therapy agents
- Use of oral anti-inflammatory agents
Who cannot join
- History of trauma to the knee area
- History of knee surgery
- Presence of systemic inflammatory disease affecting the knee joint
- Presence of peripheral neuropathy or radiculopathy
- Pregnancy
- Hemodynamic instability
Show all 10Show fewer
- Presence of skin or soft tissue infection at the injection site
- Refusal to participate in the study
- Presence of acute knee pain with accompanying inflammatory findings
- Presence of a serious psychiatric disorder or neurological disease Having received an intra-articular injection within the last 3 months
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziler Physical Medicine and Rehabilitation Training and Research Hospital
Ankara, Çankaya, 06800
About this study
Official title: Comparison of the Effectiveness of Conventional and Cooled Radiofrequency Ablation in Advanced Knee Osteoarthritis
The aim of this study was to examine and compare the effects of conventional and cooled radiofrequency ablation on pain and disability levels in patients with knee pain resistant to other treatments due to knee osteoarthritis.
- Conditions
- Knee Osteoarthritis
- Being tested
- 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 ablationDevice
Genicular nerve neurolysis with heat
| Study group | Role | What they receive |
|---|---|---|
| Conventional Radiofrequency Ablation | Active comparator | Conventional radiofrequency ablation with fluoroscopy Receives: Device: Radiofrequency ablation |
| Cooled Radiofrequency Ablation | Experimental | Cooled radiofrequency ablation with ultrasound Receives: Device: Radiofrequency ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
Patients will select their pain from 10 mm scale
Measured: Before treatment (0. week), 4 weeks after treatment (4.week), 12 weeks after treatment (12.week)
Secondary outcomes (3)
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
This scale about patient's disability due to knee osteoarthritis
Measured: Before treatment (0. week), 4 weeks after treatment (4.week), 12 weeks after treatment (12.week)
5-Point Likert Patient Satisfaction Scale
'0' =I am not happy at all, '5'=I am very pleased
Measured: Before treatment (0. week), 4 weeks after treatment (4.week), 12 weeks after treatment (12.week)
Change in frequency of analgesic use
How many analgesic did use in past week?
Measured: Before treatment (0. week), 4 weeks after treatment (4.week), 12 weeks after treatment (12.week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start1 Feb 2025
- Primary completion12 Aug 2025
- Study completion12 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse Naz Kalem, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06863181
- Sponsor's protocol ID
- AEŞH-EK-2025-064
- Status last verified
- Mar 2025
- First submitted
- 3 Mar 2025
- Last updated
- 27 Feb 2026
- 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 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Conventional and Cooled Radiofrequency Ablation in Advanced Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT06863181
- Acronym / sponsor ID
- AEŞH-EK-2025-064
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research HospitalUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 12 Aug 2025 (actual)
- Study completion
- 12 Nov 2025 (actual)
- First posted
- 7 Mar 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 aim of this study was to examine and compare the effects of conventional and cooled radiofrequency ablation on pain and disability levels in patients with knee pain resistant to other treatments due to knee osteoarthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Radiofrequency Ablation | Active comparator | Device: Radiofrequency ablationConventional radiofrequency ablation with fluoroscopy |
| Cooled Radiofrequency Ablation | Experimental | Device: Radiofrequency ablationCooled radiofrequency ablation with ultrasound |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Knee pain lasting more than 6 months
- Age between 50 and 80
- Diagnosis of radiographically proven grade III or IV knee osteoarthritis according to the Kellgren-Lawrence Grading Scale, marked narrowing of the medial compartment of the tibiofemoral joint space
- Presence of pain resistant to conservative treatment
Key exclusion criteria (10 listed)
- History of trauma to the knee area
- History of knee surgery
- Presence of systemic inflammatory disease affecting the knee joint
- Presence of peripheral neuropathy or radiculopathy
- Pregnancy
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 ablationGenicular nerve neurolysis with heat | Device | Conventional Radiofrequency Ablation, Cooled Radiofrequency Ablation |
Primary outcome
Visual Analog Scale (VAS)
Time frame: Before treatment (0. week), 4 weeks after treatment (4.week), 12 weeks after treatment (12.week)
Patients will select their pain from 10 mm scale
3 secondary outcomes
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time frame: Before treatment (0. week), 4 weeks after treatment (4.week), 12 weeks after treatment (12.week)
5-Point Likert Patient Satisfaction Scale
Time frame: Before treatment (0. week), 4 weeks after treatment (4.week), 12 weeks after treatment (12.week)
Change in frequency of analgesic use
Time frame: Before treatment (0. week), 4 weeks after treatment (4.week), 12 weeks after treatment (12.week)
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 27 Feb 2026.
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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 in people with Knee Osteoarthritis, run by Gaziler Physical Medicine and Rehabilitation Education 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 7 inclusion and 10 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 27 Feb 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?
Visual Analog Scale (VAS) (time frame: Before treatment (0. week), 4 weeks after treatment (4.week), 12 weeks after treatment (12.week)). 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 27 Feb 2026.