Cooled Versus Conventional Genicular Radiofrequency Ablation for Chronic Knee Pain

NCT04275128 | Terminated FDA Device

• 1 other identifier: HFHSCooledRFAblation
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Knee Pain

Keywords

genicular ablation; cooled radiofrequency; chronic knee pain; cooled RF; radiofrequency ablation

Outcome Measures

Primary Outcomes (1)

• 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).

  6 months

Secondary Outcomes (3)

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) knee pain score

  6 months

• Oswestry Disability Index (ODI)

  6 months

• Opioid dose after treatment

  1 day

Study Arms (2)

Conventional Genicular Ablation

This group is scheduled to receive conventional genicular ablation to treat their chronic knee pain.

Device: Conventional radiofrequency ablation

Cooled radiofrequency Ablation

This group is scheduled to receive cooled radiofrequency ablation to treat their chronic knee pain.

Device: Cooled radiofrequency ablation

Interventions

Cooled radiofrequency ablation DEVICE

Cooled radiofrequency thermal treatment uses the electrical current produced by radio waves to destroy a part of nerve tissue and relieve pain.

Also known as: Cooled radiofrequency thermal treatment

Cooled radiofrequency Ablation

Conventional radiofrequency ablation DEVICE

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.

Also known as: Genicular ablation, Genicular nerve ablation

Conventional Genicular Ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Henry Ford Health System

Detroit, Michigan, 48201, United States

Location

Related Publications (5)

• 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.

  PMID: 11676886 BACKGROUND

• Lorentzen 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.

  PMID: 8796717 BACKGROUND

• Menzies 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.

  PMID: 25857719 BACKGROUND

• McCormick 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.

  PMID: 28431129 BACKGROUND

• Davis 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.

  PMID: 29095245 BACKGROUND

Study Officials

• Rohit Aiyer, MD

  Henry Ford Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Staff Pain Medicine Physician

Study Record Dates

• First Submitted: February 17, 2020
• First Posted: February 19, 2020
• Study Start: July 11, 2020
• Primary Completion: September 24, 2020
• Study Completion: September 24, 2020
• Last Updated: September 28, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)