Knee Pain ChronicNCT05908942
Genicular RFT vs Phenol Management in Patients With Knee Osteoarthritis
An observational study of Knee Pain Chronic, run by Diskapi Teaching and Research Hospital at 2 sites in Turkey (Türkiye).
Trial summary
The aim of this study was to compare the efficacy of phenol and radiofrequency ablation for genicular nerve neurolysis in severe knee pain. The invesigators compare the efficacy of radiofrequency and phenol applications on numerical pain score and Western Ontario and McMaster Universi- ties Osteoarthritis Index… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Knee Pain Chronic
- What is being tested?
- Nerve ablation
- Type of treatment
- Medical device
- How many people
- 64 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Oct 2022to 30 Jun 2023
- How long will I take part?
- 3 Months
- Phase
- Observational
- 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 18 to 70 years
- All sexes
- Adult, Older adult
Study population: Genicular nerve radiofrequency and phenol for knee osteoarthritis male and female patients undergoing ablation
Who may be able to join
- Moderate to severe knee pain due to knee osteoarthritis (0-10 pain of intensity 6 and above on an inter-numeric pain scale)
- Permanent pain for more than 6 months
- Grade 3 or 4 in the radiological Kellgren-Lawrence classification having osteoarthritis
- Pain with conservative methods such as analgesics and physiotherapy treatment failure
Who cannot join
- History of intra-articular knee intervention in the last 6 months
- Cognitive impairment
- Hepatic or renal insufficiency
- Severe psychiatric illness
- Local or systemic infection
- Coagulopathy
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Etlik City Hospital
Ankara, Yenimahalle, 06170
Diskapi Training and Research Hospital
Ankara
About this study
Official title: Comparison of the Efficacy of Genicular Nerve Phenol Ablation and Radiofrequency Ablation for Pain Management in Patients With Knee Osteoarthritis
The aim of this study was to compare the efficacy of phenol and radiofrequency ablation for genicular nerve neurolysis in severe knee pain. The invesigators compare the efficacy of radiofrequency and phenol applications on numerical pain score and Western Ontario and McMaster Universi- ties Osteoarthritis Index (WOMAC) before, 1 and 3 months after the procedure. The procedures will be performed by applying radiofrequency waves and phenol to the genicular nerves under ultrasound guidance.
Read the detailed description
Ultrasound-guided genicular nerve ablation is a minimally invasive procedure that reduces or eliminates pain in patients with knee pain by destroying the nerves that transmit pain with heat or chemical drugs such as phenol. Genicular nerve ablation is an effective treatment option for patients with chronic knee pain who cannot undergo prosthesis surgery. In this method, radiofrequency waves or phenol are applied to the nerves going to the knee joint, preventing the transmission of pain signals to the brain.
The procedure is applied as follows:
Haemodynamic monitoring is provided. Superomedial genicular nerve (SMGS), superolateral genicular nerve (SLGS), inferomedial genicular nerve (IMGS) are the nerves to be blocked. The 8-12 Hz linear ultrasound probe is first placed superomedial to the knee and the SMGS and genicular artery are visualised at the junction of the shaft and condyle of the femur. The skin is locally anaesthetised with 2% lidocaine (2 cc) and the needle is inserted in plane with the ultrasound probe. For radiofrequency ablation The cannula placed close to the nerve is connected to the radiofrequency generator with the help of cables. At the tip of the needle, 2% lidocaine (1 cc) is administered and the nerve is heated by applying radiofrequency current. Ablation is performed at 80 °C for 1 minute. This procedure is repeated for other genicular nerves. For phenol ablation, 1 mL of 7% phenol solution is applied to cause neurolysis with the help of a needle placed close to the nerve. Phenol provides ablation by denaturing the proteins in the structure of the nerve.
Patients will be evaluated on NRS and WOMAC scales before, 1 and 3 months after the procedure. The evaluation will be done face to face and by telephone call.
- Conditions
- Knee Pain Chronic
- Being tested
- Nerve ablation
- Keywords
- Genicular radiofrequency, Phenol, Pain treatment, Osteoarthritis
- Medical subject headings
- Agnosia, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nerve ablationDevice
radiofrequency and phenol ablation of the genicular nerves will be performed
| Study group | Role | What they receive |
|---|---|---|
| RF group | 32 patients with knee osteoarthritis to undergo radiofrequency treatment of genicular nerves Receives: Device: Nerve ablation | |
| Phenol group | 32 patients with knee osteoarthritis to undergo phenol treatment of genicular nerves Receives: Device: Nerve ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric rating scale (NRS)
Patients are asked to circle the number between 0 and 10, 0 and 20 or 0 and 100 that fits best to their pain intensity.
Measured: Change from Baseline NRS at 3 months
Western Ontario and McMaster Universi- ties Osteoarthritis Index (WOMAC)
The WOMAC Pain score ranges from 0 to 20 with higher scores equating to greater pain with activities of daily living. The generic pain scale ranges from 0 to 10 for the OAI and 0 to 100 for MOST, with higher scores equating to greater pain
Measured: Change from Baseline WOMAC at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start1 Oct 2022
- Primary completion1 Apr 2023
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Pain ChronicStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Diskapi Teaching and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Damla Yürük, Diskapi Teaching and Research Hospital
- Investigators
- Gevher R Genç Perdecioğlu, Study chair, Diskapi TRH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05908942
- Sponsor's protocol ID
- Genicular
- Status last verified
- Jun 2023
- First submitted
- 5 Jun 2023
- Last updated
- 18 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Genicular Nerve Phenol Ablation and Radiofrequency Ablation for Pain Management in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT05908942
- Acronym / sponsor ID
- Genicular
- Conditions
- Knee Pain Chronic
- Keywords
- Genicular radiofrequency, Phenol, Pain treatment, Osteoarthritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Diskapi Teaching and Research HospitalUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 18 Jun 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 was to compare the efficacy of phenol and radiofrequency ablation for genicular nerve neurolysis in severe knee pain. The invesigators compare the efficacy of radiofrequency and phenol applications on numerical pain score and Western Ontario and McMaster Universi- ties Osteoarthritis Index (WOMAC) before, 1 and 3 months after the procedure. The procedures will be performed by applying radiofrequency waves and phenol to the genicular nerves under ultrasound guidance.
Detailed description
Ultrasound-guided genicular nerve ablation is a minimally invasive procedure that reduces or eliminates pain in patients with knee pain by destroying the nerves that transmit pain with heat or chemical drugs such as phenol. Genicular nerve ablation is an effective treatment option for patients with chronic knee pain who cannot undergo prosthesis surgery. In this method, radiofrequency waves or phenol are applied to the nerves going to the knee joint, preventing the transmission of pain signals to the brain.
The procedure is applied as follows:
Haemodynamic monitoring is provided. Superomedial genicular nerve (SMGS), superolateral genicular nerve (SLGS), inferomedial genicular nerve (IMGS) are the nerves to be blocked. The 8-12 Hz linear ultrasound probe is first placed superomedial to the knee and the SMGS and genicular artery are visualised at the junction of the shaft and condyle of the femur. The skin is locally anaesthetised with 2% lidocaine (2 cc) and the needle is inserted in plane with the ultrasound probe. For radiofrequency ablation The cannula placed close to the nerve is connected to the radiofrequency generator with the help of cables. At the tip of the needle, 2% lidocaine (1 cc) is administered and the nerve is heated by applying radiofrequency current. Ablation is performed at 80 °C for 1 minute. This procedure is repeated for other genicular nerves. For phenol ablation, 1 mL of 7% phenol solution is applied to cause neurolysis with the help of a needle placed close to the nerve. Phenol provides ablation by denaturing the proteins in the structure of the nerve.
Patients will be evaluated on NRS and WOMAC scales before, 1 and 3 months after the procedure. The evaluation will be done face to face and by telephone call.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RF group | – | Device: Nerve ablation32 patients with knee osteoarthritis to undergo radiofrequency treatment of genicular nerves |
| Phenol group | – | Device: Nerve ablation32 patients with knee osteoarthritis to undergo phenol treatment of genicular nerves |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Genicular nerve radiofrequency and phenol for knee osteoarthritis male and female patients undergoing ablation
Key inclusion criteria (4 listed)
- Moderate to severe knee pain due to knee osteoarthritis (0-10 pain of intensity 6 and above on an inter-numeric pain scale)
- Permanent pain for more than 6 months
- Grade 3 or 4 in the radiological Kellgren-Lawrence classification having osteoarthritis
- Pain with conservative methods such as analgesics and physiotherapy treatment failure
Key exclusion criteria (6 listed)
- History of intra-articular knee intervention in the last 6 months
- Cognitive impairment
- Hepatic or renal insufficiency
- Severe psychiatric illness
- Local or systemic infection
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 |
|---|---|---|
| Nerve ablationradiofrequency and phenol ablation of the genicular nerves will be performed | Device | Phenol group, RF group |
Primary outcome
Numeric rating scale (NRS)
Time frame: Change from Baseline NRS at 3 months
Patients are asked to circle the number between 0 and 10, 0 and 20 or 0 and 100 that fits best to their pain intensity.
Western Ontario and McMaster Universi- ties Osteoarthritis Index (WOMAC)
Time frame: Change from Baseline WOMAC at 3 months
The WOMAC Pain score ranges from 0 to 20 with higher scores equating to greater pain with activities of daily living. The generic pain scale ranges from 0 to 10 for the OAI and 0 to 100 for MOST, with higher scores equating to greater pain
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
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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.
Gevher R Genç Perdecioğlu study chair
Diskapi TRH
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Pain Chronic, run by Diskapi Teaching and Research Hospital at 2 sites 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 4 inclusion and 6 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 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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 (NRS) (time frame: Change from Baseline NRS at 3 months). 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 18 Jun 2023.