Cooled Versus Conventional Genicular Radiofrequency Ablation for Chronic Knee Pain
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|ClinicalTrials.gov Identifier: NCT04275128|
Recruitment Status : Terminated (Insurance companies no longer cover this procedure)
First Posted : February 19, 2020
Last Update Posted : September 28, 2020
|Condition or disease||Intervention/treatment|
|Chronic Knee Pain||Device: Cooled radiofrequency ablation Device: Conventional radiofrequency ablation|
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 Type :||Observational|
|Actual Enrollment :||1 participants|
|Official Title:||Cooled Genicular Radiofrequency Ablation Versus Conventional Genicular Radiofrequency Ablation for the Treatment of Chronic Knee Pain: A Prospective Study|
|Actual Study Start Date :||July 11, 2020|
|Actual Primary Completion Date :||September 24, 2020|
|Actual Study Completion Date :||September 24, 2020|
Conventional Genicular Ablation
This group is scheduled to receive conventional genicular ablation to treat their chronic knee pain.
Device: Conventional radiofrequency 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.
Cooled radiofrequency Ablation
This group is scheduled to receive cooled radiofrequency ablation to treat their chronic knee pain.
Device: Cooled radiofrequency ablation
Cooled radiofrequency thermal treatment uses the electrical current produced by radio waves to destroy a part of nerve tissue and relieve pain.
Other Name: Cooled radiofrequency thermal treatment
- 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).
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) knee pain score [ Time Frame: 6 months ]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).
- Oswestry Disability Index (ODI) [ Time Frame: 6 months ]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).
- Opioid dose after treatment [ Time Frame: 1 day ]The opioid dose given to the patient after ablation treatment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04275128
|United States, Michigan|
|Henry Ford Health System|
|Detroit, Michigan, United States, 48201|
|Principal Investigator:||Rohit Aiyer, MD||Henry Ford Health System|