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Cooled Versus Conventional Genicular Radiofrequency Ablation for Chronic Knee Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Rohit Aiyer, Henry Ford Health System

Brief 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. 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.

Condition or disease Intervention/treatment
Chronic Knee Pain Device: Cooled radiofrequency ablation Device: Conventional radiofrequency ablation

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.

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Study Type : Observational
Actual Enrollment : 1 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Group/Cohort Intervention/treatment
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.
Other Names:
  • Genicular ablation
  • Genicular nerve ablation

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




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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).

  2. 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).

  3. Opioid dose after treatment [ Time Frame: 1 day ]
    The opioid dose given to the patient after ablation treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • Pregnant adult female
  • Patient fully anticoagulated
  • Antiplatelet Use
  • History of Clotting Disorder
  • Refusal to participate
  • Focal neurologic deficits
  • Cognitive deficits
  • History of Bone Cancer
  • Mental Health Illness which causes instability
  • Previous Knee radiofrequency ablation
  • Active Infection
  • Allergy to Medications Administered

Information from the National Library of Medicine

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


Locations
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United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48201
Sponsors and Collaborators
Henry Ford Health System
Investigators
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Principal Investigator: Rohit Aiyer, MD Henry Ford Health System
Publications:
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Responsible Party: Rohit Aiyer, Senior Staff Pain Medicine Physician, Henry Ford Health System
ClinicalTrials.gov Identifier: NCT04275128    
Other Study ID Numbers: HFHSCooledRFAblation
First Posted: February 19, 2020    Key Record Dates
Last Update Posted: September 28, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Rohit Aiyer, Henry Ford Health System:
genicular ablation
cooled radiofrequency
chronic knee pain
cooled RF
radiofrequency ablation