Knee Pain ChronicNCT04940832
Outcome Measures of Pulsed Radiofrequency of the Genicular Nerves When Performed With and Without Concomitant Local Corticosteroid Administration
A study testing pulsed radiofrequency modulation in people with Knee Pain Chronic, run by Sheba Medical Center at 1 site in Israel.
Trial summary
A single blinded randomized controlled trial to compare outcomes of patients with chronic knee pain receiving radiofrequency with or without corticosteroids. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Knee Pain Chronic
- What is being tested?
- pulsed radiofrequency modulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Apr 2022to Dec 2022
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women with pain secondary to osteoarthritis of the knee
- Age of 18 years and up
- Fits criteria for procedure of genicular nerve block and pulsed radiofrequency neuromodulation
Who cannot join
- Patients who are incapable of judgment and/or to give informed consent
- Patients who are pregnant
- Patients who are under 18 years old
- Patients who have allergies to local anesthetic
- Patients with platelet dysfunction or bleeding disorders
- Patients who are currently mentally unstable
- Patients who have a diagnosis of fibromyalgia
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Sheba Medical Center
Tel HaShomer
Matthew Medwick, Doctor, 03-5303106, matt.medwick@sheba.health.gov.il
About this study
Official title: A Single Blinded Randomized Controlled Clinical Trial Comparing Outcome Measures of Pulsed Radiofrequency of the Genicular Nerves When Performed With and Without Concomitant Local Corticosteroid Administration
A single blinded randomized controlled trial to compare outcomes of patients with chronic knee pain receiving radiofrequency with or without corticosteroids.
- Conditions
- Knee Pain Chronic
- Being tested
- pulsed radiofrequency modulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pulsed radiofrequency modulationDevice
a percutaneous needle electrode to apply pulsed RF signals that modulate the activity of sensory nerves. The pulsing of the RF signal permits a maximum temperature to be achieved - usually 42 Celsius. This helps prevent collateral damage from occurring during the procedure and should help reduce procedural complications.
| Study group | Role | What they receive |
|---|---|---|
| radiofrequency with corticosteroids | Active comparator | corticosteroids- 80mg depo-medrol Pulsed radiofrequency to 42 derees celsius for 6 minutes Receives: Device: pulsed radiofrequency modulation |
| radiofrequency without corticosteroids | Active comparator | Pulsed radiofrequency to 42 derees celsius for 6 minutes Receives: Device: pulsed radiofrequency modulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in chronic knee pain
Measured by the Knee injury and Osteoarthritis Outcome Score; higher scores indicating that the patients experiences more impairment (All items are scored 0-4; for each subscale the scores are transformed to a 0-100 scale; 0 representing extreme knee problems and 100 representing no knee problems).
Measured: 2nd and 6th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study start1 Apr 2022
- Primary completionJun 2022 (estimated)
- Study completionDec 2022 (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.
- More trials run by Sheba Medical CenterThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Itay GoorAryeh, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04940832
- Sponsor's protocol ID
- Knee_pain_radiofrequency
- Status last verified
- May 2022
- First submitted
- 9 Jun 2021
- Last updated
- 9 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Blinded Randomized Controlled Clinical Trial Comparing Outcome Measures of Pulsed Radiofrequency of the Genicular Nerves When Performed With and Without Concomitant Local Corticosteroid Administration
- ClinicalTrials.gov ID
- NCT04940832
- Acronym / sponsor ID
- Knee_pain_radiofrequency
- Conditions
- Knee Pain Chronic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 28 Jun 2021 (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.
A single blinded randomized controlled trial to compare outcomes of patients with chronic knee pain receiving radiofrequency with or without corticosteroids.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| radiofrequency with corticosteroids | Active comparator | Device: pulsed radiofrequency modulationcorticosteroids- 80mg depo-medrol Pulsed radiofrequency to 42 derees celsius for 6 minutes |
| radiofrequency without corticosteroids | Active comparator | Device: pulsed radiofrequency modulationPulsed radiofrequency to 42 derees celsius for 6 minutes |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and women with pain secondary to osteoarthritis of the knee
- Age of 18 years and up
- Fits criteria for procedure of genicular nerve block and pulsed radiofrequency neuromodulation
Key exclusion criteria (7 listed)
- Patients who are incapable of judgment and/or to give informed consent
- Patients who are pregnant
- Patients who are under 18 years old
- Patients who have allergies to local anesthetic
- Patients with platelet dysfunction or bleeding 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 |
|---|---|---|
| pulsed radiofrequency modulationa percutaneous needle electrode to apply pulsed RF signals that modulate the activity of sensory nerves. The pulsing of the RF signal permits a maximum temperature to be achieved - usually 42 Celsius. This helps prevent collateral damage from occurring during the procedure and should help reduce procedural complications. | Device | radiofrequency with corticosteroids, radiofrequency without corticosteroids |
Primary outcome
Improvement in chronic knee pain
Time frame: 2nd and 6th week
Measured by the Knee injury and Osteoarthritis Outcome Score; higher scores indicating that the patients experiences more impairment (All items are scored 0-4; for each subscale the scores are transformed to a 0-100 scale; 0 representing extreme knee problems and 100 representing no knee problems).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2022.
- 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 pulsed radiofrequency modulation in people with Knee Pain Chronic, run by Sheba Medical Center at 1 site in Israel.
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 7 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 9 May 2022. 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 Israel. 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 Matthew Medwick, Doctor (03-5303106, matt.medwick@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in chronic knee pain (time frame: 2nd and 6th week). 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 9 May 2022.