Assessment of Pain Intensity Using 10-point Numerical Rating Scale (NRS-10)(9)Immediately After Intervention , 1 Week,1month,3 Months,6months and One YearPhase 1NCT06798038
Comparison of the Efficacy of Chemical Genicular Nerve Neurolysis Using Alcohol or Phenol Versus Radiofrequency Ablation Under Ultrasound Guidance for Pain Management in Patients With Knee Osteoarthritis
A Phase 1 study testing radiofrequency ablation, phenol neurolysis and alcohol neurolysis in people with Assessment of Pain Intensity Using 10-point Numerical Rating Scale (NRS-10)(9)Immediately After Intervention , 1 Week,1month,3 Months,6months and One Year and Assessment of Knee Function Using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), run by Tanta University.
Trial summary
Chronic knee pain is a common condition that affects many people, particularly those with knee osteoarthritis. It can limit mobility, reduce the quality of life, and increase the risk of falling . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Assessment of Pain Intensity Using 10-point Numerical Rating Scale (NRS-10)(9)Immediately After Intervention , 1 Week,1month,3 Months,6months and One Year, Assessment of Knee Function Using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Knee Osteoarthritis
- What is being tested?
- radiofrequency ablation, phenol neurolysis and alcohol neurolysis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2025to 1 Mar 2027
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The following will be the criteria for inclusion, (105) patients older than 18 years with moderate to severe knee pain due to knee osteoarthritis (pain of intensity six or more on a numeric rating scale [NRS], persistent pain for more than six months, grade III or IV osteoarthritis in the radiological Kellgren-Lawrence (KL) classification (5-11), and failure to manage pain with conservative methods such as analgesics, intra-articular injection, and physical therapy.
Who cannot join
- • Patients' refusal to participate in the study.
- History of intra-articular injection within three months before or after the procedure.
- Coagulopathy and anticoagulant use.
- Systemic disease as: renal or hepatic insufficiency.
- Unable to communicate with the patient.
- Implantable device.
- Previous knee surgery.
- Knee pain due to causes other than knee osteoarthritis (such as meniscopathy, trauma, spine disorder).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Chronic knee pain is a common condition that affects many people, particularly those with knee osteoarthritis. It can limit mobility, reduce the quality of life, and increase the risk of falling .
There are various treatment options for chronic knee osteoarthritis pain, including medications, physical therapy and surgery. Topical and oral analgesic medications and physical therapy, are often used in this population but with variable success and often wanting pain relief over time as the condition progresses.
Read more
Patients who fail medical treatment often undergo total knee arthroplasty (TKA) However, there are significant comorbidities associated with TKA, and most of patients suffer with chronic knee pain after this surgery Furthermore, a subset of patients are unable to undergo TKA because of medical comorbidities.
One alternative treatment option is genicular nerve ablation, which involves destroying nerves that carry pain signals from the knee joint to the brain. Genicular nerve ablation can be performed using radiofrequency ablation (RFA) or chemical agents such as phenol. Both methods aim to provide long-term pain relief and functional improvement in patients with chronic knee pain(4).
Chemical neurolytics, such as alcohol or phenol, have come to the fore because of their low cost and ease of application compared to radiofrequency ablation.These methods can be easily applied with ultrasound (US) guidance, which allows precise targeting of the relevant nerves. However, there is a lack of literature on appropriate agents and dose selection issues .
Radiofrequency neurolysis (RFN) of the genicular nerves, which provides innervation to the capsule of the knee joint, as well as to the intra-articular and extra-articular ligaments, have been of considerable interest as an effective technique to alleviated knee osteoarthritis pain .However, it requires expensive specialized equipment and trained personnel, which may not be available or affordable in some settings.
- Conditions
- Assessment of Pain Intensity Using 10-point Numerical Rating Scale (NRS-10)(9)Immediately After Intervention , 1 Week,1month,3 Months,6months and One Year, Assessment of Knee Function Using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Knee Osteoarthritis
- Being tested
- radiofrequency ablation, phenol neurolysis, alcohol neurolysis
- 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
35 Patients will be undergo for radiofrequency ablation which will be applied to each genicular nerve.
phenol neurolysisDrug
35 Patients will be administered with 2.0 ml of 6% phenol solution prepared from crystallized phenol per genicular nerve
alcohol neurolysisDrug
35 Patients will be administered with 1.0ml of 70% alcohol per genicular nerve
| Study group | Role | What they receive |
|---|---|---|
| Radiofrequency ablation group | Experimental | Not described Receives: Device: radiofrequency ablation |
| Alcohol injection group | Experimental | Not described Receives: Drug: alcohol neurolysis |
| Phenol injection group | Experimental | Not described Receives: Drug: phenol neurolysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of pain intensity using 10-point numerical rating scale (NRS-10)
Measured: immediately after intervention , 1 week,1month,3 months,6months and one year.
Secondary outcomes (2)
Assessment of Knee function using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Measured: immediately after intervention , 1 week,1month,3 months,6months and one year.
2- Assessment of the side effects and complications of these methods as (paresthesia, motor deficits, pain during application and increase in pain)
Measured: immediately after intervention , 1 week,1month,3 months,6months and one year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start1 Mar 2025 (estimated)
- Primary completion28 Feb 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Assessment of Pain Intensity Using 10-point Numerical Rating Scale (NRS-10)(9)Immediately After Intervention , 1 Week,1month,3 Months,6months and One YearStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghady Osama Makarem, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06798038
- Sponsor's protocol ID
- 36265MD337/12/24
- Status last verified
- Jan 2025
- First submitted
- 23 Jan 2025
- Last updated
- 29 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Chemical Genicular Nerve Neurolysis Using Alcohol or Phenol Versus Radiofrequency Ablation Under Ultrasound Guidance for Pain Management in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT06798038
- Acronym / sponsor ID
- 36265MD337/12/24
- Conditions
- Assessment of Pain Intensity Using 10-point Numerical Rating Scale (NRS-10)(9)Immediately After Intervention , 1 Week,1month,3 Months,6months and One Year, Assessment of Knee Function Using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Knee Osteoarthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 29 Jan 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.
Chronic knee pain is a common condition that affects many people, particularly those with knee osteoarthritis. It can limit mobility, reduce the quality of life, and increase the risk of falling .
There are various treatment options for chronic knee osteoarthritis pain, including medications, physical therapy and surgery. Topical and oral analgesic medications and physical therapy, are often used in this population but with variable success and often wanting pain relief over time as the condition progresses.
Patients who fail medical treatment often undergo total knee arthroplasty (TKA) However, there are significant comorbidities associated with TKA, and most of patients suffer with chronic knee pain after this surgery Furthermore, a subset of patients are unable to undergo TKA because of medical comorbidities.
One alternative treatment option is genicular nerve ablation, which involves destroying nerves that carry pain signals from the knee joint to the brain. Genicular nerve ablation can be performed using radiofrequency ablation (RFA) or chemical agents such as phenol. Both methods aim to provide long-term pain relief and functional improvement in patients with chronic knee pain(4).
Chemical neurolytics, such as alcohol or phenol, have come to the fore because of their low cost and ease of application compared to radiofrequency ablation.These methods can be easily applied with ultrasound (US) guidance, which allows precise targeting of the relevant nerves. However, there is a lack of literature on appropriate agents and dose selection issues .
Radiofrequency neurolysis (RFN) of the genicular nerves, which provides innervation to the capsule of the knee joint, as well as to the intra-articular and extra-articular ligaments, have been of considerable interest as an effective technique to alleviated knee osteoarthritis pain .However, it requires expensive specialized equipment and trained personnel, which may not be available or affordable in some settings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Radiofrequency ablation group | Experimental | Device: radiofrequency ablation |
| Alcohol injection group | Experimental | Drug: alcohol neurolysis |
| Phenol injection group | Experimental | Drug: phenol neurolysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The following will be the criteria for inclusion, (105) patients older than 18 years with moderate to severe knee pain due to knee osteoarthritis (pain of intensity six or more on a numeric rating scale [NRS], persistent pain for more than six months, grade III or IV osteoarthritis in the radiological Kellgren-Lawrence (KL) classification (5-11), and failure to manage pain with conservative methods such as analgesics, intra-articular injection, and physical therapy.
Key exclusion criteria (8 listed)
- • Patients' refusal to participate in the study.
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 ablation35 Patients will be undergo for radiofrequency ablation which will be applied to each genicular nerve. | Device | Radiofrequency ablation group |
| phenol neurolysis35 Patients will be administered with 2.0 ml of 6% phenol solution prepared from crystallized phenol per genicular nerve | Drug | Phenol injection group |
| alcohol neurolysis35 Patients will be administered with 1.0ml of 70% alcohol per genicular nerve | Drug | Alcohol injection group |
Primary outcome
Assessment of pain intensity using 10-point numerical rating scale (NRS-10)
Time frame: immediately after intervention , 1 week,1month,3 months,6months and one year.
2 secondary outcomes
Assessment of Knee function using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: immediately after intervention , 1 week,1month,3 months,6months and one year.
2- Assessment of the side effects and complications of these methods as (paresthesia, motor deficits, pain during application and increase in pain)
Time frame: immediately after intervention , 1 week,1month,3 months,6months and one year.
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 29 Jan 2025.
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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing radiofrequency ablation, phenol neurolysis and alcohol neurolysis in people with Assessment of Pain Intensity Using 10-point Numerical Rating Scale (NRS-10)(9)Immediately After Intervention , 1 Week,1month,3 Months,6months and One Year and Assessment of Knee Function Using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), run by Tanta University.
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 1 inclusion and 8 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: opening soon, as of the sponsor's last update on 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Tanta University (0020403317928, support_net@unv.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of pain intensity using 10-point numerical rating scale (NRS-10) (time frame: immediately after intervention , 1 week,1month,3 months,6months and one year.). 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 29 Jan 2025.