Comparison of Heated vs. Pulsed Radiofrequency Treatment of the Genicular Nerves for Osteoarthritis Knee Pain

NCT04379895 | Unknown FDA Device

• 1 other identifier: 0087-19-RMB CTIL
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a prospective, randomised, interventional, double blinded study to compare the clinical outcomes of thermal vs. pulsed radiofrequency (RF) treatment of the genicular nerves in patients with painful osteoarthritis (OA) of the knee. Population: 60 patients, aged 50 and above, with painful OA of the knee. Interventional measures: Pulsed or heated RF treatment of the genicular nerves of the involved knee. Outcome measures: primary - fraction of patients experiencing improvement of 50% or higher in their average pain rating during stair climbing. secondary - improved quality of life

• improved functional capacity
• comparison of side effects and adverse events
• change in the consumption of analgesic medications

Conditions

Osteoarthritis, Knee

Keywords

treatment; radiofrequency; genicular nerves

Outcome Measures

Primary Outcomes (1)

• Knee pain reduction

  Reduction in knee pain during stairs climbing by at least 50% in a 1-10 Numerical Rating Scale (NRS) pain severity score and a comparison between the 2 techniques outcomes.

  3 months

Secondary Outcomes (2)

• quality of life measurements improvement

  3 months

• Adverse events

  3 months

Study Arms (2)

Heated RF ablation

ACTIVE COMPARATOR

Patients with OA that will undergo heated RF of the genicular nerves

Device: Radiofrequency ablation

Pulsed RF ablation

ACTIVE COMPARATOR

Patients with OA that will undergo pulsed RF of the genicular nerves

Device: Radiofrequency ablation

Interventions

Radiofrequency ablation DEVICE

Pulsed or heated RF ablation of the genicular nerves will be done as an Acceptable treatment for OA of the knee

Heated RF ablation; Pulsed RF ablation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Radiologically proven OA of knee with a 2. Kellgren-Lawrence scale (K-L score) of 3 to 4.
• Clinically proven OA of knee with an Oxford knee score of 0 to 30 (representing moderate to severe OA).
• Chronic knee pain due to the OA of knee (\>3 months) of at least moderate severity by a Visual Analogue Scale (VAS) 4 and above.
• Signed informed consent

You may not qualify if:

• Acute knee pain
• Disease that preclude per clinician decision interventional treatment.
• Allergic reaction to the injected substances (triamcinolone, lidocaine)
• Injections to the knee during the 3 months preceding recruitment
• Distorted knee intervention due to any cause, which interferes with the radiological identification of targeted RF sites.
• Anticoagulation treatment that cannot be stopped.

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Related Publications (6)

• Gupta A, Huettner DP, Dukewich M. Comparative Effectiveness Review of Cooled Versus Pulsed Radiofrequency Ablation for the Treatment of Knee Osteoarthritis: A Systematic Review. Pain Physician. 2017 Mar;20(3):155-171.

  PMID: 28339430 BACKGROUND

• Choi WJ, Hwang SJ, Song JG, Leem JG, Kang YU, Park PH, Shin JW. Radiofrequency treatment relieves chronic knee osteoarthritis pain: a double-blind randomized controlled trial. Pain. 2011 Mar;152(3):481-487. doi: 10.1016/j.pain.2010.09.029. Epub 2010 Nov 4.

  PMID: 21055873 BACKGROUND

• Cohen SP, Peterlin BL, Fulton L, Neely ET, Kurihara C, Gupta A, Mali J, Fu DC, Jacobs MB, Plunkett AR, Verdun AJ, Stojanovic MP, Hanling S, Constantinescu O, White RL, McLean BC, Pasquina PF, Zhao Z. Randomized, double-blind, comparative-effectiveness study comparing pulsed radiofrequency to steroid injections for occipital neuralgia or migraine with occipital nerve tenderness. Pain. 2015 Dec;156(12):2585-2594. doi: 10.1097/j.pain.0000000000000373.

  PMID: 26447705 BACKGROUND

• Kroll HR, Kim D, Danic MJ, Sankey SS, Gariwala M, Brown M. A randomized, double-blind, prospective study comparing the efficacy of continuous versus pulsed radiofrequency in the treatment of lumbar facet syndrome. J Clin Anesth. 2008 Nov;20(7):534-7. doi: 10.1016/j.jclinane.2008.05.021.

  PMID: 19041042 BACKGROUND

• Protzman NM, Gyi J, Malhotra AD, Kooch JE. Examining the feasibility of radiofrequency treatment for chronic knee pain after total knee arthroplasty. PM R. 2014 Apr;6(4):373-6. doi: 10.1016/j.pmrj.2013.10.003. Epub 2013 Dec 27.

  PMID: 24373908 BACKGROUND

• Iannaccone F, Dixon S, Kaufman A. A Review of Long-Term Pain Relief after Genicular Nerve Radiofrequency Ablation in Chronic Knee Osteoarthritis. Pain Physician. 2017 Mar;20(3):E437-E444.

  PMID: 28339444 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff pain physician

Study Record Dates

• First Submitted: March 3, 2020
• First Posted: May 8, 2020
• Study Start: June 1, 2020
• Primary Completion: June 1, 2022
• Study Completion: August 1, 2022
• Last Updated: May 13, 2020

Record last verified: 2020-05