NCT05930756

Brief Summary

The goal of this clinical trial is to compare three-point and six-point Genicular Nerve Radiofrequency Ablation (GNRFA) in adults with chronic knee osteoarthritis (KOA). The main question it aims to answer is whether six- target GNRFA technique is more efficacious than standard three-target GNRFA technique in managing the pain and function of KOA. Consented patients who respond to a diagnostic block will be randomly assigned to either three-point or six-point GNRFA. Researchers will compare pain and function in these two groups.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 26, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 5, 2023

Completed
1.7 years until next milestone

Study Start

First participant enrolled

March 9, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

December 3, 2024

Status Verified

November 1, 2024

Enrollment Period

10 months

First QC Date

June 26, 2023

Last Update Submit

November 28, 2024

Conditions

Osteoarthritis, KneeChronic Pain

Keywords

Radiofrequency ablationOsteoarthritis, KneeGenicular radiofrequency ablation

Outcome Measures

Primary Outcomes (1)

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

    The Western Ontario and McMaster Universities Osteoarthritis (WOMAC) pain scale quantifies knee pain severity with activities of daily living. It is a self-administered instrument containing 24 items measuring 3 subscales: physical function (17 items), pain (5 items), and stiffness (2 items). Higher points signify higher levels of functional difficulty. This will be captured by change in WOMAC scores from baseline at 12 weeks

    12 weeks

Secondary Outcomes (3)

  • Numerical rating scale

    4 time points: 30 min, 4 weeks, 12 weeks, 24 week spost procedure

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

    2 time points: 4 weeks and 24 weeks post procedure

  • Opioid intake

    24 weeks post procedure

Other Outcomes (1)

  • Incidence of adverse effects

    3 time points: 4 weeks, 12 weeks, and 24 weeks post procedure

Study Arms (2)

Three-target GNRFA technique (T1)

ACTIVE COMPARATOR

Radiofrequency ablation will target three of the genicular nerves: the superolateral genicular nerve, the superomedial genicular nerve, and the inferomedial genicular nerve.

Procedure: Radiofrequency ablation

Six-target GNRFA technique (T2)

ACTIVE COMPARATOR

Radiofrequency ablation will target six of the genicular nerves: the superolateral genicular nerve, the superomedial genicular nerve, the inferomedial genicular nerve, two branches from the nerve of vastus intermedius, and the recurrent fibular nerve

Procedure: Radiofrequency ablation

Interventions

Radiofrequency ablationPROCEDURE

Genicular radiofrequency ablation uses thermal energy to percutaneously create lesions in neural tissues of the genicular nerves that innervate the anterior knee capsule and disrupt the conduction of pain signals.

Six-target GNRFA technique (T2)Three-target GNRFA technique (T1)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 years or older
  • Chronic knee pain for at least 3 months with radiological evidence of KOA graded 2-4 on the Kellgren-Lawrence scale as determined by a radiologist

You may not qualify if:

  • unwilling,
  • unable to communicate in English,
  • have acute knee pain,
  • prior knee surgery,
  • allergies to local anesthetics,
  • chronic opioid consumption of daily morphine equivalent of \>30 mg for at least four weeks prior to procedure,
  • neurologic diseases affecting the lower limbs (i.e. previous CVA, MS),
  • connective tissue diseases affecting the knee,
  • treatment with intra-articular steroid injections and/or hyaluronic acid in the previous 3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (12)

  • Conger A, Gililland J, Anderson L, Pelt CE, Peters C, McCormick ZL. Genicular Nerve Radiofrequency Ablation for the Treatment of Painful Knee Osteoarthritis: Current Evidence and Future Directions. Pain Med. 2021 Jul 25;22(Suppl 1):S20-S23. doi: 10.1093/pm/pnab129.

    PMID: 34308957BACKGROUND

  • Molloy, L. (2022, May 10). Wait times for priority procedures in Canada. CIHI. Retrieved September 10, 2022, from https://www.cihi.ca/en/wait-times-for-priority-procedures-in-canada

    BACKGROUND

  • Oudhoff JP, Timmermans DR, Knol DL, Bijnen AB, van der Wal G. Waiting for elective general surgery: impact on health related quality of life and psychosocial consequences. BMC Public Health. 2007 Jul 19;7:164. doi: 10.1186/1471-2458-7-164.

    PMID: 17640382BACKGROUND

  • Tate, Q., Conger, A., Burnham, T. et al. The Effectiveness and Safety of Genicular Nerve Radiofrequency Ablation for the Treatment of Recalcitrant Knee Pain Due to Osteoarthritis: a Comprehensive Literature Review. Curr Phys Med Rehabil Rep 7, 404-413 (2019). https://doi.org/10.1007/s40141-019-00246-3

    BACKGROUND

  • Fogarty AE, Burnham T, Kuo K, Tate Q, Sperry BP, Cheney C, Walega DR, Kohan L, Cohen SP, Cushman DM, McCormick ZL, Conger A. The Effectiveness of Fluoroscopically Guided Genicular Nerve Radiofrequency Ablation for the Treatment of Chronic Knee Pain Due to Osteoarthritis: A Systematic Review. Am J Phys Med Rehabil. 2022 May 1;101(5):482-492. doi: 10.1097/PHM.0000000000001813. Epub 2021 May 27.

    PMID: 35006653BACKGROUND

  • Hong T, Wang H, Li G, Yao P, Ding Y. Systematic Review and Meta-Analysis of 12 Randomized Controlled Trials Evaluating the Efficacy of Invasive Radiofrequency Treatment for Knee Pain and Function. Biomed Res Int. 2019 Jun 26;2019:9037510. doi: 10.1155/2019/9037510. eCollection 2019.

    PMID: 31346525BACKGROUND

  • 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: 21055873BACKGROUND

  • McCormick ZL, Cohen SP, Walega DR, Kohan L. Technical considerations for genicular nerve radiofrequency ablation: optimizing outcomes. Reg Anesth Pain Med. 2021 Jun;46(6):518-523. doi: 10.1136/rapm-2020-102117. Epub 2021 Jan 22.

    PMID: 33483425BACKGROUND

  • Tran J, Peng PWH, Lam K, Baig E, Agur AMR, Gofeld M. Anatomical Study of the Innervation of Anterior Knee Joint Capsule: Implication for Image-Guided Intervention. Reg Anesth Pain Med. 2018 May;43(4):407-414. doi: 10.1097/AAP.0000000000000778.

    PMID: 29557887BACKGROUND

  • Fonkoue L, Stoenoiu MS, Behets CW, Steyaert A, Kouassi JK, Detrembleur C, Cornu O. Validation of a new protocol for ultrasound-guided genicular nerve radiofrequency ablation with accurate anatomical targets: cadaveric study. Reg Anesth Pain Med. 2021 Mar;46(3):210-216. doi: 10.1136/rapm-2020-101936. Epub 2020 Dec 3.

    PMID: 33273065BACKGROUND

  • Ahmed A, Arora D. Ultrasound-Guided Neurolysis of Six Genicular Nerves for Intractable Pain from Knee Osteoarthritis: A Case Series. Pain Pract. 2019 Jan;19(1):16-26. doi: 10.1111/papr.12710. Epub 2018 Aug 8.

    PMID: 29761638BACKGROUND

  • Koshi E, Meiling JB, Conger AM, McCormick ZL, Burnham TR. Long-term clinical outcomes of genicular nerve radiofrequency ablation for chronic knee pain using a three-tined electrode for expanded nerve capture. Interv Pain Med. 2021 Nov 19;1(1):100003. doi: 10.1016/j.inpm.2021.100003. eCollection 2022 Mar.

    PMID: 39301447BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, KneeChronic Pain

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Central Study Contacts

Antonella Tidy

CONTACT

905-525-9140tonitidy@mcmaster.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
The patient will be sedated and positioned so that they will not know which of the two treatments they receive. The outcomes assessor will not know which treatment the patient received, as they will not be present during the procedure. The care provider (if present) will not be told. Only care providers involved in the procedure are unblinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2023

First Posted

July 5, 2023

Study Start

March 9, 2025

Primary Completion

December 31, 2025

Study Completion

April 1, 2026

Last Updated

December 3, 2024

Record last verified: 2024-11