Thermal Radiofrequency NeurolysisNCT07125768
Thermal Radiofrequency Neurolysis Versus Alcoholic Neurolysis of the Genicular Nerves for Treatment of Chronic Knee Pain in Advanced Knee Osteoarthritis
A study testing Thermal Radiofrequency Neurolysis and Alcoholic Neurolysis in people with Thermal Radiofrequency Neurolysis and Alcoholic Neurolysis, run by Tanta University at 1 site in Egypt.
Trial summary
This study aimed to compare the strength and duration of pain relief, quality of life and analgesic consumption between patients who undergo conventional thermal radiofrequency vs patients who undergo chemical neurolysis on genicular nerves by alcohol in chronic knee osteoarthritis pain. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Thermal Radiofrequency Neurolysis, Alcoholic Neurolysis, Genicular Nerves
- What is being tested?
- Thermal Radiofrequency Neurolysis and Alcoholic Neurolysis
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2024to 1 Jul 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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age from 40 to 60 years.
- Both sexes.
- Stage 3 and 4 knee osteoarthritis in patients who aren't responding to pharmacological treatment and aren't good candidates for knee replacement surgery.
Who cannot join
- Neurological disorders (Previous cerebrovascular stroke, neuropathy, or weakness).
- Bleeding disorders.
- Infection at or near the injection site.
- Presence of a pacemaker or defibrillator.
- Acute knee injury.
- Unstable knee joint.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study Between Thermal Radiofrequency Neurolysis Versus Alcoholic Neurolysis of the Genicular Nerves for Treatment of Chronic Knee Pain in Advanced Knee Osteoarthritis
This study aimed to compare the strength and duration of pain relief, quality of life and analgesic consumption between patients who undergo conventional thermal radiofrequency vs patients who undergo chemical neurolysis on genicular nerves by alcohol in chronic knee osteoarthritis pain.
Read the detailed description
Knee osteoarthritis is a degenerative joint disease characterized by the degradation of the articular cartilage, with many factors implicated in the disease pathogenesis.
Chronic pain of knee osteoarthritis is a common clinical symptom leading to restricted movement, disability, psychological distress, and impaired quality of life.
The targeted genicular nerves are those that had a close topographic relationship with the bone cortical surfaces, such as the femoral epicondyles (Superior medial [SM] and Superior lateral [SL] genicular nerves) and the medial tibial epicondyle (Inferior medial [IM] genicular nerve).
Nerve ablation causes iatrogenic neural degeneration, aiming only for sensory or sympathetic denervation without motor deficits. The nerve ablation methods currently available are performed by either thermal ablation using radiofrequency or chemical ablation using alcohol or phenol.
Chemical neurolysis techniques can be an effective method to accomplish a larger, more thorough lesioning than radiofrequency ablation and are capable of covering the anatomical variability of genicular nerves, so ensuring a better success rate and outcome with less cost and less logistic support.
- Conditions
- Thermal Radiofrequency Neurolysis, Alcoholic Neurolysis, Genicular Nerves, Treatment, Chronic Knee Pain, Advanced Knee Osteoarthritis
- Being tested
- Thermal Radiofrequency Neurolysis, Alcoholic Neurolysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermal Radiofrequency NeurolysisOther
Patients received C-arm guided neurolysis of superior medial [SM], superior lateral [SL], and inferior medial [IM] genicular nerves by thermal radiofrequency.
Alcoholic NeurolysisOther
Patients received C-arm guided injection of each of the three genicular nerves with 1 ml of a solution containing 70% alcohol in 0.25% lidocaine.
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | Patients received C-arm guided neurolysis of superior medial [SM], superior lateral [SL], and inferior medial [IM] genicular nerves by thermal radiofrequency. Receives: Other: Thermal Radiofrequency Neurolysis |
| Group II | Active comparator | Patients received C-arm guided injection of each of the three genicular nerves with 1 ml of a solution containing 70% alcohol in 0.25% lidocaine. Receives: Other: Alcoholic Neurolysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of knee osteoarthritis pain
Improvement of knee osteoarthritis pain according to Visual Analogue Scale (VAS). VAS: which was a subjective scale used to quantitatively assess pain (0 = No pain, 10 = Severe pain).
Measured: 6 months post-procedure
Secondary outcomes (2)
Improvement of quality of life
Improvement of quality of life according to Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score. WOMAC is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscale areas: Each scale uses the following descriptors for all items: none, mild moderate, severe, and extreme. These correspond to an ordinal scale of 0-4. The scores were summed up for items in each subscale, with possible ranges as follows: pain=0-20, stiffness=0-8, physical function=0-68.
Measured: 6 months post-procedure
Decrease of analgesic requirements of pain control after neurolysis.
All patients received standard analgesic regimen in the form of non-steroidal anti-inflammatory drugs (Diclofenac Sodium) until they reach the same satisfactory level of pain control, and we asked the patient to use diary to record the amount of analgesia used during the follow up period.
Measured: 6 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2025
- Study start1 Jul 2024
- Primary completion1 Jul 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thermal Radiofrequency NeurolysisStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Participant, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hesham Mahmoud Elsayed Eldamhogy, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07125768
- Sponsor's protocol ID
- 36264MS603/5/24
- Status last verified
- Aug 2025
- First submitted
- 10 Aug 2025
- Last updated
- 15 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of the study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Thermal Radiofrequency Neurolysis Versus Alcoholic Neurolysis of the Genicular Nerves for Treatment of Chronic Knee Pain in Advanced Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT07125768
- Acronym / sponsor ID
- 36264MS603/5/24
- Conditions
- Thermal Radiofrequency Neurolysis, Alcoholic Neurolysis, Genicular Nerves, Treatment, Chronic Knee Pain, Advanced Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 15 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.
This study aimed to compare the strength and duration of pain relief, quality of life and analgesic consumption between patients who undergo conventional thermal radiofrequency vs patients who undergo chemical neurolysis on genicular nerves by alcohol in chronic knee osteoarthritis pain.
Detailed description
Knee osteoarthritis is a degenerative joint disease characterized by the degradation of the articular cartilage, with many factors implicated in the disease pathogenesis.
Chronic pain of knee osteoarthritis is a common clinical symptom leading to restricted movement, disability, psychological distress, and impaired quality of life.
The targeted genicular nerves are those that had a close topographic relationship with the bone cortical surfaces, such as the femoral epicondyles (Superior medial [SM] and Superior lateral [SL] genicular nerves) and the medial tibial epicondyle (Inferior medial [IM] genicular nerve).
Nerve ablation causes iatrogenic neural degeneration, aiming only for sensory or sympathetic denervation without motor deficits. The nerve ablation methods currently available are performed by either thermal ablation using radiofrequency or chemical ablation using alcohol or phenol.
Chemical neurolysis techniques can be an effective method to accomplish a larger, more thorough lesioning than radiofrequency ablation and are capable of covering the anatomical variability of genicular nerves, so ensuring a better success rate and outcome with less cost and less logistic support.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Other: Thermal Radiofrequency NeurolysisPatients received C-arm guided neurolysis of superior medial [SM], superior lateral [SL], and inferior medial [IM] genicular nerves by thermal radiofrequency. |
| Group II | Active comparator | Other: Alcoholic NeurolysisPatients received C-arm guided injection of each of the three genicular nerves with 1 ml of a solution containing 70% alcohol in 0.25% lidocaine. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age from 40 to 60 years.
- Both sexes.
- Stage 3 and 4 knee osteoarthritis in patients who aren't responding to pharmacological treatment and aren't good candidates for knee replacement surgery.
Key exclusion criteria (6 listed)
- Neurological disorders (Previous cerebrovascular stroke, neuropathy, or weakness).
- Bleeding disorders.
- Infection at or near the injection site.
- Presence of a pacemaker or defibrillator.
- Acute knee injury.
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 |
|---|---|---|
| Thermal Radiofrequency NeurolysisPatients received C-arm guided neurolysis of superior medial [SM], superior lateral [SL], and inferior medial [IM] genicular nerves by thermal radiofrequency. | Other | Group I |
| Alcoholic NeurolysisPatients received C-arm guided injection of each of the three genicular nerves with 1 ml of a solution containing 70% alcohol in 0.25% lidocaine. | Other | Group II |
Primary outcome
Improvement of knee osteoarthritis pain
Time frame: 6 months post-procedure
Improvement of knee osteoarthritis pain according to Visual Analogue Scale (VAS). VAS: which was a subjective scale used to quantitatively assess pain (0 = No pain, 10 = Severe pain).
2 secondary outcomes
Improvement of quality of life
Time frame: 6 months post-procedure
Decrease of analgesic requirements of pain control after neurolysis.
Time frame: 6 months post-procedure
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 15 Aug 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of the study for one year.
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 Thermal Radiofrequency Neurolysis and Alcoholic Neurolysis in people with Thermal Radiofrequency Neurolysis and Alcoholic Neurolysis, run by Tanta University at 1 site in Egypt.
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 3 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: finished, as of the sponsor's last update on 15 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 Egypt. 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?
Improvement of knee osteoarthritis pain (time frame: 6 months post-procedure). 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 15 Aug 2025.