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Standard Versus Novel RFA for Chronic Knee Pain in Osteoarthritis

23. juni 2026 opdateret af: John Tran, Lawson Research Institute of St. Joseph's

A Prospective Pilot Study Comparing Standard and Novel Radiofrequency Ablation Protocols for Chronic Knee Pain in Osteoarthritis

Brief Summary

The goal of this pilot study is to evaluate the feasibility and safety of conducting a randomized comparison of two standard-of-care knee radiofrequency ablation (RFA) techniques in adults with chronic knee pain related to knee osteoarthritis.

Participants who are already scheduled to receive knee RFA as part of their standard clinical care will be randomized to receive either a standard 3-target (standard) RFA protocol or a 6-target (novel) RFA protocol. The main purpose of this pilot study is to determine whether a future larger randomized trial comparing these two RFA approaches is feasible and safe to conduct.

Participants will complete questionnaires about pain, knee function, and stiffness at baseline and at follow-up timepoints for up to 12 months after the RFA procedure. Preliminary pain relief outcomes will also be explored to help inform the design of a future definitive trial.

Participants already scheduled for a knee RFA procedure as part of their standard of care for pain related to knee osteoarthritis will answer online survey questions about their pain for up to 12 months.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This is a prospective, longitudinal, single-centre randomized pilot study with follow-up to 12 months. Participants scheduled to receive standard-of-care knee RFA for chronic knee pain related to osteoarthritis will be randomized through REDCap in a 1:1 manner to receive either the standard 3-target RFA protocol or the novel 6-target RFA protocol.

In usual clinical care, the RFA technique would typically be selected by the treating physician and both techniques are being done as standard of care. In this study, assignment to one of the two RFA techniques will be randomized. The RFA procedure itself will be completed as part of standard clinical care.

Study-related activities include randomization, collection of limited demographic and clinical information from the medical record, collection of procedural information, adverse event monitoring, and participant-reported outcome assessments. Outcomes will be collected at baseline before the procedure and at 3, 6, 9, and 12 months post-procedure. Follow-up may be discontinued at or after 6 months if the participant's pain returns to baseline levels or if the participant undergoes a repeat procedure.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

24

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  1. Any patient with knee osteoarthritis receiving knee RFA.
  2. Stable pain medications for past 1 month.
  3. Able to speak English.

Exclusion Criteria:

  1. Scheduled for knee surgery within 6 months following RFA procedure.
  2. Participating in another study that the Principal Investigator or Co-Investigators deem will interfere with the interpretation of the results.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Traditional RFA
Participants randomized to this arm will receive the standard 3-target knee RFA protocol as part of their standard clinical care.
Procedure: Radiofrequency ablation - 3-target technique
X-ray imaging is used to guide needles that target the superior lateral, superior medial, and inferior medial genicular nerves surrounding the knee, heat is used to ablate the nerves.
Aktiv komparator: Novel RFA
Participants randomized to this arm will receive the 6-target knee RFA protocol as part of their standard clinical care.
Procedure: Radiofrequency ablation - 6-target technique
X-ray imaging is used to guide needle placement for radiofrequency ablation targeting the superior lateral, superior medial, and inferior medial genicular nerve regions around the knee. The 6-target protocol also includes supplementary ablation lesions at three additional target sites around the knee. These additional targets are treated by adjusting the needle angle once inserted, without requiring additional needle insertions beyond the standard approach.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Nature of adverse events
Tidsramme: up to 12 months
The types of adverse events occurring while participants are in the study will be reviewed.
up to 12 months
Frequency of adverse events
Tidsramme: up to 12 months
defined by the number of adverse events a participant experiences while participating in the study
up to 12 months
Recruitment rate
Tidsramme: During enrolment period
Average number of participants enrolled per month during the recruitment period.
During enrolment period
Retention and Attrition Rates
Tidsramme: 3, 6, 9, and 12 months post-procedure
proportion of participants retained and the proportion lost to follow-up at each scheduled follow-up timepoint
3, 6, 9, and 12 months post-procedure
Questionnaire Completion Rate
Tidsramme: Baseline, 3, 6, 9, and 12 months post-procedure
completion rates for the Patient Numeric Rating Scale (PNRS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaires at each scheduled study timepoint.
Baseline, 3, 6, 9, and 12 months post-procedure
Procedural efficiency
Tidsramme: Baseline
total procedure duration, measured from needle placement to final lesion completion. The 6-target protocol will be compared with the 3-target protocol to determine whether it adds no more than 20 minutes on average and remains within the 60-minute operating room threshold.
Baseline

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in functional outcomes
Tidsramme: Baseline, as well as 3-, 6-, 9-, and 12-months post-procedure on the following questionnaires.
measured by The Western Ontario and McMaster Universities Osteoarthritis Index
Baseline, as well as 3-, 6-, 9-, and 12-months post-procedure on the following questionnaires.
Average time to return to <50% pain relief
Tidsramme: Baseline, as well as 3-, 6-, 9-, and 12-months post-procedure
Measured by the pain numeric rating scale, where zero is equivalent to no pain and 10 indicates the worst possible pain
Baseline, as well as 3-, 6-, 9-, and 12-months post-procedure
Average time to return to baseline pain level
Tidsramme: baseline, 3 months, 6 months, 9 months and 12 months post procedure
Measured by the pain numeric rating scale (PNRS), where 0 indicates no pain, and 10 indicates worst imaginable pain.
baseline, 3 months, 6 months, 9 months and 12 months post procedure

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Lawson Research Institute of St. Joseph's

Samarbejdspartnere

St. Joseph's Health Care London
Western University

Efterforskere

  • Studiestol: Eldon Loh, MD, Lawson Health Research Institute of St. Joseph's
  • Ledende efterforsker: John Tran, PhD, Lawson Health Research Institute of St. Joseph's

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

20. juli 2026

Primær færdiggørelse (Anslået)

20. august 2028

Studieafslutning (Anslået)

20. august 2029

Datoer for studieregistrering

Først indsendt

22. juni 2026

Først indsendt, der opfyldte QC-kriterier

23. juni 2026

Først opslået (Faktiske)

29. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • JTNRFA001

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Individual patient data for this study includes standard of care procedure administered, date of the procedure, and the location of the procedure can be easily found through public information on the study, increasing the risk for a privacy breach.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Slidgigt, knæ

Kliniske forsøg med Radiofrequency ablation - 3-target technique

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