PercutaneousNCT06520371
Percutaneous vs Conventional Radiofrequency Applications for the Treatment of Knee Osteoarthritic Pain
A study testing Percutaneous radiofrequency and Conventional radiofrequency in people with Percutaneous and Conventional, run by Tanta University at 1 site in Egypt.
Trial summary
This study aims to compare percutaneous and conventional radiofrequency applications for the treatment of knee osteoarthritic pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Percutaneous, Conventional, Radiofrequency
- What is being tested?
- Percutaneous radiofrequency and Conventional radiofrequency
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Jul 2024to 31 Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years old.
- Both sexes.
- Patients with knee osteoarthritis.
- Previous conservative treatments longer than 3 months.
- Visual analog scale (VAS)≥ 4.
- Radiological osteoarthritis grades 3 and 4 according to the Kellgren-Lawrence grading system (0 = none, 1 = doubtful, 2 = minimal, 3 = moderate, and 4 = severe).
Who cannot join
- Prior knee surgery.
- Allergies to local anesthetics.
- Connective tissue diseases affect the knee.
- Serious neurologic or psychiatric disorders.
- Injection with steroids or hyaluronic acids during the previous 3 months.
- History of septic arthritis.
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- Sciatic pain.
- Cardiac pacemaker users.
- Anticoagulant medications.
- Prior electroacupuncture treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Percutaneous and Conventional Radiofrequency Applications for the Treatment of Knee Osteoarthritic Pain: A Randomized Controlled Trial
This study aims to compare percutaneous and conventional radiofrequency applications for the treatment of knee osteoarthritic pain.
Read the detailed description
Osteoarthritis (OA) is a progressive degenerative joint disease that affects the joint cartilage and surrounding tissues. It mostly affects the weight-bearing joints, and in this respect, the knee joint is one of the joints that is most affected.
Radiofrequency (RF) treatment has been used for several painful conditions such as trigeminal neuralgia, cancer pain, and spinal pain. To destroy nerves or disrupt the transmission of pain signals, originally using producing heat lesions, RF current is applied to the trigeminal ganglion, the spinothalamic tracts of the spinal cord, the medial branches of posterior rami, and the dorsal root ganglion. In addition to these, there have been a few attempts to apply RF current for the treatment of painful conditions of joints of the extremities.
Percutaneous radiofrequency ablation (RFA) of articular sensory nerves has recently emerged as an attractive and minimally invasive approach to treat chronic pain due to large-joint osteoarthritis in select patients.
- Conditions
- Percutaneous, Conventional, Radiofrequency, Knee Osteoarthritis, Pain
- Being tested
- Percutaneous radiofrequency, Conventional radiofrequency
- Medical subject headings
- Osteoarthritis, Knee, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous radiofrequencyDevice
For the percutaneous radiofrequency treatment, a medium electrode size will be placed on either side of the knee: one skin electrode on the inside and one on the outside of the knee for 15 minutes.
Conventional radiofrequencyDevice
For the conventional radiofrequency treatment, a 50 Hz sensory stimulation will be performed with a 10 cm, 22 gauge, 10 mm active tip radiofrequency cannula. After receiving the appropriate sensory and motor stimuli, a radiofrequency of 90°C will be applied for 90 s.
| Study group | Role | What they receive |
|---|---|---|
| Percutaneous radiofrequency group | Experimental | Patients will receive percutaneous radiofrequency. Receives: Device: Percutaneous radiofrequency |
| Conventional radiofrequency group | Active comparator | Patients will receive conventional radiofrequency. Receives: Device: Conventional radiofrequency |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of pain
Degree of pain will be assessed using visual analog scale (VAS). Each patient will obtain a score between 0 and 10 (Zero means no pain, and ten means the worst pain). VAS will be assessed pre-procedure and post-procedure 2nd, 6th, and 12th week.
Measured: 12th week post-procedure
Secondary outcomes (3)
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores: range from 0 to 96 (0 represents the best health status and 96 the worst possible status). The higher the score, the poorer the function. It will be assessed pre-procedure and post-procedure 1, 4, and 12th week.
Measured: 12th week post-procedure
Patient satisfaction
Degree of patient satisfaction will be assessed on a 5-point Likert scale Patient satisfaction (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied ; 5, extremely satisfied). It will be assessed pre-procedure and post-procedure 1, 4, and 12th week.
Measured: 12th week post-procedure
Incidence of adverse events
Incidence of adverse events such as bleeding, neurological damage, infection, abnormal proprioception, numbness, paresthesia, and motor weakness will be recorded.
Measured: 12th week post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start25 Jul 2024
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PercutaneousStudies 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
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Said ElSharkawy, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06520371
- Sponsor's protocol ID
- 36264PR670/4/24
- Status last verified
- Jan 2025
- First submitted
- 21 Jul 2024
- Last updated
- 28 Jan 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 study for one year.
Publications
El Kashef AM, Elsharkawy MS, Shaheen MM, Abdelwahed WM, El Malla DA, El-Hamid AS, Ismail DM, Taha AK. Comparison of percutaneous and conventional radiofrequency applications for the treatment of knee osteoarthritic pain: a randomized controlled trial. Minerva Anestesiol. 2026 Apr;92(4):298-304. doi: 10.23736/S0375-9393.26.19414-0.
PubMed 42099217
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Percutaneous and Conventional Radiofrequency Applications for the Treatment of Knee Osteoarthritic Pain: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06520371
- Acronym / sponsor ID
- 36264PR670/4/24
- Conditions
- Percutaneous, Conventional, Radiofrequency, Knee Osteoarthritis, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 25 Jul 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 25 Jul 2024 (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 aims to compare percutaneous and conventional radiofrequency applications for the treatment of knee osteoarthritic pain.
Detailed description
Osteoarthritis (OA) is a progressive degenerative joint disease that affects the joint cartilage and surrounding tissues. It mostly affects the weight-bearing joints, and in this respect, the knee joint is one of the joints that is most affected.
Radiofrequency (RF) treatment has been used for several painful conditions such as trigeminal neuralgia, cancer pain, and spinal pain. To destroy nerves or disrupt the transmission of pain signals, originally using producing heat lesions, RF current is applied to the trigeminal ganglion, the spinothalamic tracts of the spinal cord, the medial branches of posterior rami, and the dorsal root ganglion. In addition to these, there have been a few attempts to apply RF current for the treatment of painful conditions of joints of the extremities.
Percutaneous radiofrequency ablation (RFA) of articular sensory nerves has recently emerged as an attractive and minimally invasive approach to treat chronic pain due to large-joint osteoarthritis in select patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Percutaneous radiofrequency group | Experimental | Device: Percutaneous radiofrequencyPatients will receive percutaneous radiofrequency. |
| Conventional radiofrequency group | Active comparator | Device: Conventional radiofrequencyPatients will receive conventional radiofrequency. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age > 18 years old.
- Both sexes.
- Patients with knee osteoarthritis.
- Previous conservative treatments longer than 3 months.
- Visual analog scale (VAS)≥ 4.
Key exclusion criteria (10 listed)
- Prior knee surgery.
- Allergies to local anesthetics.
- Connective tissue diseases affect the knee.
- Serious neurologic or psychiatric disorders.
- Injection with steroids or hyaluronic acids during the previous 3 months.
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 |
|---|---|---|
| Percutaneous radiofrequencyFor the percutaneous radiofrequency treatment, a medium electrode size will be placed on either side of the knee: one skin electrode on the inside and one on the outside of the knee for 15 minutes. | Device | Percutaneous radiofrequency group |
| Conventional radiofrequencyFor the conventional radiofrequency treatment, a 50 Hz sensory stimulation will be performed with a 10 cm, 22 gauge, 10 mm active tip radiofrequency cannula. After receiving the appropriate sensory and motor stimuli, a radiofrequency of 90°C will be applied for 90 s. | Device | Conventional radiofrequency group |
Primary outcome
Degree of pain
Time frame: 12th week post-procedure
Degree of pain will be assessed using visual analog scale (VAS). Each patient will obtain a score between 0 and 10 (Zero means no pain, and ten means the worst pain). VAS will be assessed pre-procedure and post-procedure 2nd, 6th, and 12th week.
3 secondary outcomes
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores
Time frame: 12th week post-procedure
Patient satisfaction
Time frame: 12th week post-procedure
Incidence of adverse events
Time frame: 12th week 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 28 Jan 2025.
- Derived from this study: PubMed 42099217El Kashef AM, Elsharkawy MS, Shaheen MM, Abdelwahed WM, El Malla DA, El-Hamid AS, Ismail DM, Taha AK. Comparison of percutaneous and conventional radiofrequency applications for the treatment of knee osteoarthritic pain: a randomized controlled trial. Minerva Anestesiol. 2026 Apr;92(4):298-304. doi: 10.23736/S0375-9393.26.19414-0.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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 Percutaneous radiofrequency and Conventional radiofrequency in people with Percutaneous and Conventional, 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 6 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 28 Jan 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?
Degree of pain (time frame: 12th week post-procedure). 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 NCT06520371, which also lists 1 linked publication.
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 28 Jan 2025.