Chronic Knee OsteoarthritisNCT06173830
Ultrasound-guided Radiofrequency Ablation of the Genicular Nerve Versus Physical Therapy for Chronic Knee Osteoarthritis
A study testing radiofrequency ablation and physical therapy in people with Chronic Knee Osteoarthritis, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to compare the effects of conventional physiotherapy methods with ultrasound-guided radiofrequency ablation of the genicular nerve on pain and functional status in patients with stage 2-3 chronic knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 45 to 70 years
- Conditions the study is for
- Chronic Knee Osteoarthritis
- What is being tested?
- radiofrequency ablation and physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2023to 15 Apr 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 45 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- VAS ≥ 5
- To be aged between 45 and 70 years old
- Patients diagnosed with chronic knee osteoarthritis using the American College of Rheumatology criteria and having radiological osteoarthritis of Kellgren-Lawrence grade 2 and 3
- Cognitive functions being intact
- Being willing to participate in the study and signing the consent forms
Who cannot join
- Having received physical therapy for chronic knee osteoarthritis in the last 6 months
- Having received glucocorticoid or hyaluronic acid injections in the last 6 months
- Having taken oral glucosamine
- Undergoing knee surgery
- Having current neurological or mental disorders
- History of pacemaker usage
Show all 15Show fewer
- Presence of local infections or sepsis
- Progressive neurological deficit
- Presence of oncological diseases
- Hemorrhagic diathesis or anticoagulation
- Uncontrolled diabetes or other serious internal comorbidities
- Allergy to medications or materials used
- Pregnancy
- Lack of cooperation
- Not willing to participate in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Bilkent City Hospital Physical Therapy and Rehabilitation Hospital
Ankara, Bilkent - Çankaya, 06800
Merve Çakır, Medical Doctor, +905388523339, drmervecakir1@gmail.com
About this study
Official title: Comparison of the Effectiveness of Physical Therapy With Ultrasound-Guided Radiofrequency Ablation of the Genicular Nerve in Patients With Chronic Knee Osteoarthritis
The aim of this study is to compare the effects of conventional physiotherapy methods with ultrasound-guided radiofrequency ablation of the genicular nerve on pain and functional status in patients with stage 2-3 chronic knee osteoarthritis.
Read the detailed description
Patients diagnosed with Chronic Knee Osteoarthritis according to the American College of Rheumatology criteria, and with radiological osteoarthritis at Kellgren-Lawrence grades 2 and 3, within the age range of 45-70, and meeting the study criteria will be included in the study. After providing information about the procedures to be performed and potential risks to the patients, if they give their written informed consent, treatment methods will be applied to the patients. Eligible patients will be divided into two groups. In one group, Radiofrequency Ablation of the Genicular Nerve under Ultrasound Guidance will be performed, while the other group will receive physical therapy.
- Conditions
- Chronic Knee Osteoarthritis
- Being tested
- radiofrequency ablation, physical therapy
- Keywords
- knee osteoarthritis, genicular nerve block, Ultrasound, radiofrequency, Chronic pain
- Medical subject headings
- Osteoarthritis, Knee, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiofrequency ablationOther
34 patients with chronic knee osteoarthritis meeting the criteria will undergo ultrasound-guided radiofrequency ablation of the genicular nerve.
physical therapyOther
34 patients with chronic knee osteoarthritis meeting the criteria will undergo 10 sessions of physical therapy.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound-guided radiofrequency ablation of the genicular nerve in chronic knee osteoarthritis | Active comparator | A total of 34 patients with chronic knee osteoarthritis meeting the criteria will undergo ultrasound-guided radiofrequency ablation of the genicular nerve. Receives: Other: radiofrequency ablation |
| physical therapy for chronic knee osteoarthritis | Active comparator | Thirty-four patients with chronic knee osteoarthritis meeting the criteria will receive 10 sessions of physical therapy. Receives: Other: physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
Scale. The Visual Analog Scale (VAS) is evaluated on a scale ranging from "no pain" to "worst possible pain." The value of 0 (zero) indicates "no pain," while the value of 10 (ten) indicates "the most severe pain imaginable."
Measured: Before treatment (initial), after 2 weeks and 12 weeks changes
Secondary outcomes (3)
The Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Questionnaire. The WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) test is a disease-specific, valid, and reliable measure for osteoarthritis, comprising 24 questions in three subcategories: pain, stiffness, and physical function. Each question is scored using the Likert scale as follows: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe. Scores for each section are calculated independently, and the total score ranges from 0 to 100. Higher scores indicate an increase in pain and stiffness, as well as a deterioration in physical function.
Measured: Before treatment (initial), after 2 weeks and 12 weeks changes
The 6-minute walk test (6MWT)
The 6MWT is an assessment to measure the distance a person is capable of walking on a flat, hard surface in 6 minutes. It is a useful test to measure the response of all the bodily systems that a person uses while exercising.
Measured: Before treatment (initial), after 2 weeks and 12 weeks changes
EuroQol scale (EQ-5D-3L)
Questionnaire. The EuroQol (EQ) scale, developed by the EuroQol Group, is a general tool for measuring overall quality of life. The EQ-5D-3L (3-level version) is a widely used scale for assessing health status. The EQ-5D-3L consists of two main components: the EQ-5D descriptive system and the EQ visual analog scale (EQ VAS).
In the first component, the EQ-5D descriptive system, health status is evaluated in five dimensions: "Mobility, Self-Care, Usual Activities, Pain/Discomfort, Anxiety/Depression." Each dimension has three levels: "1=No problems," "2=Moderate problems," and "3=Severe problems." Combinations derived from these five dimensions create an index score to express individuals' overall health status.
The second component is the visual analog scale (EQ VAS), where the patient self-assesses their health on a vertical visual analog scale with endpoints labeled 'Best imaginable health state=100' and 'Worst imaginable health state=0'.
Measured: Before treatment (initial), after 2 weeks and 12 weeks changes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study start15 Oct 2023
- Primary completion15 Jan 2024 (estimated)
- Study completion15 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Knee 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Çakır, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06173830
- Sponsor's protocol ID
- 10026603
- Status last verified
- Dec 2023
- First submitted
- 22 Nov 2023
- Last updated
- 18 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Choi WJ, Hwang SJ, Song JG, Leem JG, Kang YU, Park PH, Shin JW. Radiofrequency treatment relieves chronic knee osteoarthritis pain: a double-blind randomized controlled trial. Pain. 2011 Mar;152(3):481-487. doi: 10.1016/j.pain.2010.09.029. Epub 2010 Nov 4.
PubMed 21055873McCormick ZL, Korn M, Reddy R, Marcolina A, Dayanim D, Mattie R, Cushman D, Bhave M, McCarthy RJ, Khan D, Nagpal G, Walega DR. Cooled Radiofrequency Ablation of the Genicular Nerves for Chronic Pain due to Knee Osteoarthritis: Six-Month Outcomes. Pain Med. 2017 Sep 1;18(9):1631-1641. doi: 10.1093/pm/pnx069.
PubMed 28431129Kesikburun S, Yasar E, Uran A, Adiguzel E, Yilmaz B. Ultrasound-Guided Genicular Nerve Pulsed Radiofrequency Treatment For Painful Knee Osteoarthritis: A Preliminary Report. Pain Physician. 2016 Jul;19(5):E751-9.
PubMed 27389118
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Physical Therapy With Ultrasound-Guided Radiofrequency Ablation of the Genicular Nerve in Patients With Chronic Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT06173830
- Acronym / sponsor ID
- 10026603
- Conditions
- Chronic Knee Osteoarthritis
- Keywords
- knee osteoarthritis, genicular nerve block, Ultrasound, radiofrequency, Chronic pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 15 Oct 2023 (actual)
- Primary completion
- 15 Jan 2024 (estimated)
- Study completion
- 15 Apr 2024 (estimated)
- First posted
- 18 Dec 2023 (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 is to compare the effects of conventional physiotherapy methods with ultrasound-guided radiofrequency ablation of the genicular nerve on pain and functional status in patients with stage 2-3 chronic knee osteoarthritis.
Detailed description
Patients diagnosed with Chronic Knee Osteoarthritis according to the American College of Rheumatology criteria, and with radiological osteoarthritis at Kellgren-Lawrence grades 2 and 3, within the age range of 45-70, and meeting the study criteria will be included in the study. After providing information about the procedures to be performed and potential risks to the patients, if they give their written informed consent, treatment methods will be applied to the patients. Eligible patients will be divided into two groups. In one group, Radiofrequency Ablation of the Genicular Nerve under Ultrasound Guidance will be performed, while the other group will receive physical therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound-guided radiofrequency ablation of the genicular nerve in chronic knee osteoarthritis | Active comparator | Other: radiofrequency ablationA total of 34 patients with chronic knee osteoarthritis meeting the criteria will undergo ultrasound-guided radiofrequency ablation of the genicular nerve. |
| physical therapy for chronic knee osteoarthritis | Active comparator | Other: physical therapyThirty-four patients with chronic knee osteoarthritis meeting the criteria will receive 10 sessions of physical therapy. |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- VAS ≥ 5
- To be aged between 45 and 70 years old
- Patients diagnosed with chronic knee osteoarthritis using the American College of Rheumatology criteria and having radiological osteoarthritis of Kellgren-Lawrence grade 2 and 3
- Cognitive functions being intact
- Being willing to participate in the study and signing the consent forms
Key exclusion criteria (15 listed)
- Having received physical therapy for chronic knee osteoarthritis in the last 6 months
- Having received glucocorticoid or hyaluronic acid injections in the last 6 months
- Having taken oral glucosamine
- Undergoing knee surgery
- Having current neurological or mental disorders
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 ablation34 patients with chronic knee osteoarthritis meeting the criteria will undergo ultrasound-guided radiofrequency ablation of the genicular nerve. | Other | Ultrasound-guided radiofrequency ablation of the genicular nerve in chronic knee osteoarthritis |
| physical therapy34 patients with chronic knee osteoarthritis meeting the criteria will undergo 10 sessions of physical therapy. | Other | physical therapy for chronic knee osteoarthritis |
Primary outcome
Visual Analog Scale (VAS)
Time frame: Before treatment (initial), after 2 weeks and 12 weeks changes
Scale. The Visual Analog Scale (VAS) is evaluated on a scale ranging from "no pain" to "worst possible pain." The value of 0 (zero) indicates "no pain," while the value of 10 (ten) indicates "the most severe pain imaginable."
3 secondary outcomes
The Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time frame: Before treatment (initial), after 2 weeks and 12 weeks changes
The 6-minute walk test (6MWT)
Time frame: Before treatment (initial), after 2 weeks and 12 weeks changes
EuroQol scale (EQ-5D-3L)
Time frame: Before treatment (initial), after 2 weeks and 12 weeks changes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2023.
- Background: PubMed 21055873Choi WJ, Hwang SJ, Song JG, Leem JG, Kang YU, Park PH, Shin JW. Radiofrequency treatment relieves chronic knee osteoarthritis pain: a double-blind randomized controlled trial. Pain. 2011 Mar;152(3):481-487. doi: 10.1016/j.pain.2010.09.029. Epub 2010 Nov 4.
- Background: PubMed 28431129McCormick ZL, Korn M, Reddy R, Marcolina A, Dayanim D, Mattie R, Cushman D, Bhave M, McCarthy RJ, Khan D, Nagpal G, Walega DR. Cooled Radiofrequency Ablation of the Genicular Nerves for Chronic Pain due to Knee Osteoarthritis: Six-Month Outcomes. Pain Med. 2017 Sep 1;18(9):1631-1641. doi: 10.1093/pm/pnx069.
- Results publication: PubMed 27389118Kesikburun S, Yasar E, Uran A, Adiguzel E, Yilmaz B. Ultrasound-Guided Genicular Nerve Pulsed Radiofrequency Treatment For Painful Knee Osteoarthritis: A Preliminary Report. Pain Physician. 2016 Jul;19(5):E751-9.
- 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.
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 and physical therapy in people with Chronic Knee Osteoarthritis, 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 5 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 18 Dec 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fatma Gül Yurdakul, Associate Professor (medical) (+905059254214, fatmagulonder@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) (time frame: Before treatment (initial), after 2 weeks and 12 weeks changes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06173830, which also lists 3 linked publications.
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 18 Dec 2023.