Chronic Knee PainNCT04275128
Cooled Versus Conventional Genicular Radiofrequency Ablation for Chronic Knee Pain
An observational study of Chronic Knee Pain, run by Henry Ford Health System at 1 site in United States.
Trial summary
This prospective observational study seeks to compare pain relief and disability following cooled radiofrequency ablation (Coolief) versus conventional genicular nerve ablation in patients with chronic knee pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Knee Pain
- What is being tested?
- Cooled radiofrequency ablation and Conventional radiofrequency ablation
- Type of treatment
- Medical device
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jul 2020to 24 Sep 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients diagnosed with chronic knee osteoarthritis or post-knee surgical pain, being treated with either cooled radiofrequency ablation at any of the five study locations (HFH Main and HFMC- Ford Rd, HFMC- Columbus, HFMC-Pierson, HFH West Bloomfield) between February 2020 and December 2021.
Who may be able to join
- Adult male or female (above age of 18)
- Diagnosed with chronic knee osteoarthritis or post Total Knee Arthroscopy or post Total Knee Replacement Pain
- More than 3 months of knee pain
- Scheduled for Genicular Knee ablation (Cooled or conventional ablation)
- Had previous intra articular injection (steroids or Hyaluronic acids) if not a post-surgical knee pain patient
- Achieved minimum 50% relief from genicular block x 2
- Numeric Rating Scale Score of 4 or greater
- Kellgren-Lawrence Knee Osteoarthritis Grade 2 or greater (in non post-surgical patients)
Who cannot join
- Pregnant adult female
- Patient fully anticoagulated
- Antiplatelet Use
- History of Clotting Disorder
- Refusal to participate
- Focal neurologic deficits
Show all 12Show fewer
- Cognitive deficits
- History of Bone Cancer
- Mental Health Illness which causes instability
- Previous Knee radiofrequency ablation
- Active Infection
- Allergy to Medications Administered
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cooled Genicular Radiofrequency Ablation Versus Conventional Genicular Radiofrequency Ablation for the Treatment of Chronic Knee Pain: A Prospective Study
This prospective observational study seeks to compare pain relief and disability following cooled radiofrequency ablation (Coolief) versus conventional genicular nerve ablation in patients with chronic knee pain. Patients' NRS for pain, WOMAC, and ODI score at baseline and 1, 3 and 6 months after treatment will be used to evaluate whether Coolief is more effective at reducing disability and improving pain relief.
Read the detailed description
This prospective observational study seeks to compare pain relief at 1 month, 3 months and 6 months following cooled radiofrequency ablation vs conventional genicular nerve ablation in patients with chronic knee pain.
Both cooled RF and conventional genicular nerve ablation use the electrical current produced by radio waves to destroy a part of nerve tissue, creating a lesion and relieving pain (Kapural and Mekhail 2001). The conventional probe emanates heat that can damage surrounding tissues, and the lesion produced is limited in size. Cooled radiofrequency (RF) probes have a system of water running through the probe tip that keeps the probe tip at a lower temperature (Lorentzen 2015). Coolief produces larger spherical-shaped lesions, meaning an increased area of nerve destruction with less heat damage to surrounding tissues (Menzies and Hawkins 2015).
In 2017, the FDA cleared the Cooled radiofrequency thermal treatment device (Coolief, Halyard Health, Alpharetta, GA, USA) for knee osteoarthritis. McCormick et al investigated 33 patients with knee osteoarthritis pain, and after 6 months, 35% of patients had at least 50% or greater reduction in Numeric Rating Scale (NRS) for Pain, and 19% had complete pain relief. In another study by Davis et al, they compared, prospective, multicenter, randomized trial of 151 patients that compared cooled radiofrequency ablation genicular against intraarticular steroid injection. At 6 months, the cooled radiofrequency ablation group had more favorable outcomes in NRS: pain reduction 50% or greater was 74.1% in the ablation group versus 16.2% in the intraarticular group. Henry Ford Hospital Pain center introduced cooled radiofrequency ablation treatment modality in 2017 and it's currently being used in patients with chronic knee osteoarthritis and post-surgical knee pain.
This study will follow patients who have been diagnosed with chronic knee osteoarthritis or post-surgical knee pain and are scheduled to undergo Coolief or conventional ablation to treat their chronic knee pain. At 1, 3 and 6 months following their treatment, the study team will call patients on the phone to give them to ask about their pain and disability, using the NRS for pain, WOMAC for knee pain, and ODI questionnaire. Baseline and post-treatment scores will be compared to determine if Coolief elicits a more pronounced impact on reduced pain and disability than the conventional technique.
We expect to find a greater reduction in pain and disability experienced by patients who undergo the newer, cooled radiofrequency ablation when compared to the conventional ablation technique, at 1, 3- and 6-months after the procedure. The information gained from this study will be used to guide future ablation treatment, to ensure that patients receive the most effective pain relief treatment for their chronic knee pain.
- Conditions
- Chronic Knee Pain
- Being tested
- Cooled radiofrequency ablation, Conventional radiofrequency ablation
- Keywords
- genicular ablation, cooled radiofrequency, chronic knee pain, cooled RF, radiofrequency ablation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cooled radiofrequency ablationDevice
Also called Cooled radiofrequency thermal treatment
Cooled radiofrequency thermal treatment uses the electrical current produced by radio waves to destroy a part of nerve tissue and relieve pain.
Conventional radiofrequency ablationDevice
Also called Genicular ablation, Genicular nerve ablation
Genicular nerve ablation involves using radiofrequency to heat up the genicular nerve until it dies, causing relief of pain. This is a minimally invasive treatment that does not require any medication.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Genicular Ablation | This group is scheduled to receive conventional genicular ablation to treat their chronic knee pain. Receives: Device: Conventional radiofrequency ablation | |
| Cooled radiofrequency Ablation | This group is scheduled to receive cooled radiofrequency ablation to treat their chronic knee pain. Receives: Device: Cooled radiofrequency ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Rating Scale (NRS) Pain Score
This is a validated scale which consists of a rating of pain intensity from 0 (no pain) to 10 (worst possible pain). Score reported will be a number, and therefore a value between 0 to 10, with 0 meaning no pain to 10 meaning maximum pain (Krebs et al, 2007).
Measured: 6 months
Secondary outcomes (3)
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) knee pain score
The specific knee pain Short-form Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a validated questionnaire which measures pain, stiffness and functional limitation. Describe the details of the version you will be using. It is comprised of 24 items divided into three subscales: Pain (5 questions), stiffness (2 questions), and physical function (17 questions). Each question is scored on a scale of 0-4 with regards to severity, with 0 meaning no severity and 4 meaning extreme severity. Values are summed up for a combined WOMAC score, with 0 being the lowest, and 96 being the highest (or worst in severity with regards to pain, stiffness and limitations in function (Bellamy et al).
Measured: 6 months
Oswestry Disability Index (ODI)
The Oswestry Disability Index (ODI) is a validated questionnaire used to quantify disability for low back pain. It consists of ten questions, each scored 0-5, with zero indicating the least amount of disability and 5 indicating the most severe disability. The scores are summed and multiplied by two to produce a final score ranging between 0 to 100, with zero meaning no disability and 100 meaning the maximum disability (Fairbank and Pynsent 2000).
Measured: 6 months
Opioid dose after treatment
The opioid dose given to the patient after ablation treatment
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2020
- Study start11 Jul 2020
- Primary completion24 Sep 2020
- Study completion24 Sep 2020
Why it stopped: Insurance companies no longer cover this procedure
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic Knee PainStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rohit Aiyer, Henry Ford Health System
- Investigators
- Rohit Aiyer, MD, Principal investigator, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04275128
- Sponsor's protocol ID
- HFHSCooledRFAblation
- Status last verified
- Sep 2020
- First submitted
- 17 Feb 2020
- Last updated
- 28 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Kapural L, Mekhail N. Radiofrequency ablation for chronic pain control. Curr Pain Headache Rep. 2001 Dec;5(6):517-25. doi: 10.1007/s11916-001-0069-z.
PubMed 11676886Lorentzen T. A cooled needle electrode for radiofrequency tissue ablation: thermodynamic aspects of improved performance compared with conventional needle design. Acad Radiol. 1996 Jul;3(7):556-63. doi: 10.1016/s1076-6332(96)80219-4.
PubMed 8796717Menzies RD, Hawkins JK. Analgesia and Improved Performance in a Patient Treated by Cooled Radiofrequency for Pain and Dysfunction Postbilateral Total Knee Replacement. Pain Pract. 2015 Jul;15(6):E54-8. doi: 10.1111/papr.12292. Epub 2015 Apr 10.
PubMed 25857719McCormick ZL, Korn M, Reddy R, Marcolina A, Dayanim D, Mattie R, Cushman D, Bhave M, McCarthy RJ, Khan D, Nagpal G, Walega DR. Cooled Radiofrequency Ablation of the Genicular Nerves for Chronic Pain due to Knee Osteoarthritis: Six-Month Outcomes. Pain Med. 2017 Sep 1;18(9):1631-1641. doi: 10.1093/pm/pnx069.
PubMed 28431129Davis T, Loudermilk E, DePalma M, Hunter C, Lindley D, Patel N, Choi D, Soloman M, Gupta A, Desai M, Buvanendran A, Kapural L. Prospective, Multicenter, Randomized, Crossover Clinical Trial Comparing the Safety and Effectiveness of Cooled Radiofrequency Ablation With Corticosteroid Injection in the Management of Knee Pain From Osteoarthritis. Reg Anesth Pain Med. 2018 Jan;43(1):84-91. doi: 10.1097/AAP.0000000000000690.
PubMed 29095245
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cooled Genicular Radiofrequency Ablation Versus Conventional Genicular Radiofrequency Ablation for the Treatment of Chronic Knee Pain: A Prospective Study
- ClinicalTrials.gov ID
- NCT04275128
- Acronym / sponsor ID
- HFHSCooledRFAblation
- Conditions
- Chronic Knee Pain
- Keywords
- genicular ablation, cooled radiofrequency, chronic knee pain, cooled RF, radiofrequency ablation
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Insurance companies no longer cover this procedure
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- 11 Jul 2020 (actual)
- Primary completion
- 24 Sep 2020 (actual)
- Study completion
- 24 Sep 2020 (actual)
- First posted
- 19 Feb 2020 (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 prospective observational study seeks to compare pain relief and disability following cooled radiofrequency ablation (Coolief) versus conventional genicular nerve ablation in patients with chronic knee pain. Patients' NRS for pain, WOMAC, and ODI score at baseline and 1, 3 and 6 months after treatment will be used to evaluate whether Coolief is more effective at reducing disability and improving pain relief.
Detailed description
This prospective observational study seeks to compare pain relief at 1 month, 3 months and 6 months following cooled radiofrequency ablation vs conventional genicular nerve ablation in patients with chronic knee pain.
Both cooled RF and conventional genicular nerve ablation use the electrical current produced by radio waves to destroy a part of nerve tissue, creating a lesion and relieving pain (Kapural and Mekhail 2001). The conventional probe emanates heat that can damage surrounding tissues, and the lesion produced is limited in size. Cooled radiofrequency (RF) probes have a system of water running through the probe tip that keeps the probe tip at a lower temperature (Lorentzen 2015). Coolief produces larger spherical-shaped lesions, meaning an increased area of nerve destruction with less heat damage to surrounding tissues (Menzies and Hawkins 2015).
In 2017, the FDA cleared the Cooled radiofrequency thermal treatment device (Coolief, Halyard Health, Alpharetta, GA, USA) for knee osteoarthritis. McCormick et al investigated 33 patients with knee osteoarthritis pain, and after 6 months, 35% of patients had at least 50% or greater reduction in Numeric Rating Scale (NRS) for Pain, and 19% had complete pain relief. In another study by Davis et al, they compared, prospective, multicenter, randomized trial of 151 patients that compared cooled radiofrequency ablation genicular against intraarticular steroid injection. At 6 months, the cooled radiofrequency ablation group had more favorable outcomes in NRS: pain reduction 50% or greater was 74.1% in the ablation group versus 16.2% in the intraarticular group. Henry Ford Hospital Pain center introduced cooled radiofrequency ablation treatment modality in 2017 and it's currently being used in patients with chronic knee osteoarthritis and post-surgical knee pain.
This study will follow patients who have been diagnosed with chronic knee osteoarthritis or post-surgical knee pain and are scheduled to undergo Coolief or conventional ablation to treat their chronic knee pain. At 1, 3 and 6 months following their treatment, the study team will call patients on the phone to give them to ask about their pain and disability, using the NRS for pain, WOMAC for knee pain, and ODI questionnaire. Baseline and post-treatment scores will be compared to determine if Coolief elicits a more pronounced impact on reduced pain and disability than the conventional technique.
We expect to find a greater reduction in pain and disability experienced by patients who undergo the newer, cooled radiofrequency ablation when compared to the conventional ablation technique, at 1, 3- and 6-months after the procedure. The information gained from this study will be used to guide future ablation treatment, to ensure that patients receive the most effective pain relief treatment for their chronic knee pain.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Genicular Ablation | – | Device: Conventional radiofrequency ablationThis group is scheduled to receive conventional genicular ablation to treat their chronic knee pain. |
| Cooled radiofrequency Ablation | – | Device: Cooled radiofrequency ablationThis group is scheduled to receive cooled radiofrequency ablation to treat their chronic knee pain. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients diagnosed with chronic knee osteoarthritis or post-knee surgical pain, being treated with either cooled radiofrequency ablation at any of the five study locations (HFH Main and HFMC- Ford Rd, HFMC- Columbus, HFMC-Pierson, HFH West Bloomfield) between February 2020 and December 2021.
Key inclusion criteria (8 listed)
- Adult male or female (above age of 18)
- Diagnosed with chronic knee osteoarthritis or post Total Knee Arthroscopy or post Total Knee Replacement Pain
- More than 3 months of knee pain
- Scheduled for Genicular Knee ablation (Cooled or conventional ablation)
- Had previous intra articular injection (steroids or Hyaluronic acids) if not a post-surgical knee pain patient
Key exclusion criteria (12 listed)
- Pregnant adult female
- Patient fully anticoagulated
- Antiplatelet Use
- History of Clotting Disorder
- Refusal to participate
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 |
|---|---|---|
| Cooled radiofrequency ablationAlso: Cooled radiofrequency thermal treatmentCooled radiofrequency thermal treatment uses the electrical current produced by radio waves to destroy a part of nerve tissue and relieve pain. | Device | Cooled radiofrequency Ablation |
| Conventional radiofrequency ablationAlso: Genicular ablation, Genicular nerve ablationGenicular nerve ablation involves using radiofrequency to heat up the genicular nerve until it dies, causing relief of pain. This is a minimally invasive treatment that does not require any medication. | Device | Conventional Genicular Ablation |
Primary outcome
Numerical Rating Scale (NRS) Pain Score
Time frame: 6 months
This is a validated scale which consists of a rating of pain intensity from 0 (no pain) to 10 (worst possible pain). Score reported will be a number, and therefore a value between 0 to 10, with 0 meaning no pain to 10 meaning maximum pain (Krebs et al, 2007).
3 secondary outcomes
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) knee pain score
Time frame: 6 months
Oswestry Disability Index (ODI)
Time frame: 6 months
Opioid dose after treatment
Time frame: 1 day
Results and safety
The study was stopped early (reason given: Insurance companies no longer cover this procedure). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2020.
- Background: PubMed 11676886Kapural L, Mekhail N. Radiofrequency ablation for chronic pain control. Curr Pain Headache Rep. 2001 Dec;5(6):517-25. doi: 10.1007/s11916-001-0069-z.
- Background: PubMed 8796717Lorentzen T. A cooled needle electrode for radiofrequency tissue ablation: thermodynamic aspects of improved performance compared with conventional needle design. Acad Radiol. 1996 Jul;3(7):556-63. doi: 10.1016/s1076-6332(96)80219-4.
- Background: PubMed 25857719Menzies RD, Hawkins JK. Analgesia and Improved Performance in a Patient Treated by Cooled Radiofrequency for Pain and Dysfunction Postbilateral Total Knee Replacement. Pain Pract. 2015 Jul;15(6):E54-8. doi: 10.1111/papr.12292. Epub 2015 Apr 10.
- Background: PubMed 28431129McCormick ZL, Korn M, Reddy R, Marcolina A, Dayanim D, Mattie R, Cushman D, Bhave M, McCarthy RJ, Khan D, Nagpal G, Walega DR. Cooled Radiofrequency Ablation of the Genicular Nerves for Chronic Pain due to Knee Osteoarthritis: Six-Month Outcomes. Pain Med. 2017 Sep 1;18(9):1631-1641. doi: 10.1093/pm/pnx069.
- Background: PubMed 29095245Davis T, Loudermilk E, DePalma M, Hunter C, Lindley D, Patel N, Choi D, Soloman M, Gupta A, Desai M, Buvanendran A, Kapural L. Prospective, Multicenter, Randomized, Crossover Clinical Trial Comparing the Safety and Effectiveness of Cooled Radiofrequency Ablation With Corticosteroid Injection in the Management of Knee Pain From Osteoarthritis. Reg Anesth Pain Med. 2018 Jan;43(1):84-91. doi: 10.1097/AAP.0000000000000690.
- 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.
Rohit Aiyer, MD principal investigator
Henry Ford Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Knee Pain, run by Henry Ford Health System at 1 site in United States.
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 8 inclusion and 12 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: stopped early, as of the sponsor's last update on 28 Sep 2020. 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 United States. 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 was stopped early (reason given: Insurance companies no longer cover this procedure). 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?
Numerical Rating Scale (NRS) Pain Score (time frame: 6 months). 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 NCT04275128, which also lists 5 linked publications.
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 Sep 2020; AzTrials last refreshed its copy on 7 Nov 2026.