Standard Versus Novel RFA for Chronic Knee Pain in Osteoarthritis
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.
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Melissa Calleja, MSc
- Telefonní číslo: 42208 519-646-6100
- E-mail: melissa.calleja@sjhc.london.on.ca
Studijní záloha kontaktů
- Jméno: Arden Lawson, MSc
- Telefonní číslo: 42570 519-646-6100
- E-mail: arden.lawson@sjhc.london.on.ca
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Any patient with knee osteoarthritis receiving knee RFA.
- Stable pain medications for past 1 month.
- Able to speak English.
Exclusion Criteria:
- Scheduled for knee surgery within 6 months following RFA procedure.
- Participating in another study that the Principal Investigator or Co-Investigators deem will interfere with the interpretation of the results.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Aktivní komparátor: Traditional RFA
Participants randomized to this arm will receive the standard 3-target knee RFA protocol as part of their standard clinical care.
|
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.
|
|
Aktivní komparátor: Novel RFA
Participants randomized to this arm will receive the 6-target knee RFA protocol as part of their standard clinical care.
|
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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Nature of adverse events
Časové okno: 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
Časové okno: 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
Časové okno: During enrolment period
|
Average number of participants enrolled per month during the recruitment period.
|
During enrolment period
|
|
Retention and Attrition Rates
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in functional outcomes
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Studijní židle: Eldon Loh, MD, Lawson Health Research Institute of St. Joseph's
- Vrchní vyšetřovatel: John Tran, PhD, Lawson Health Research Institute of St. Joseph's
Publikace a užitečné odkazy
Obecné publikace
- Julious, S.A. (2005), Sample size of 12 per group rule of thumb for a pilot study. Pharmaceut. Statist., 4: 287-291. https://doi.org/10.1002/pst.185
- Tran J, McCormick ZL, Lanting BA, Lisk K, Loh E. Patient-specific knee radiofrequency ablation using contrast spread analysis and 3D anatomy knowledge: teaching Images. Pain Med. 2026 Mar 1;27(3):370-373. doi: 10.1093/pm/pnaf137. No abstract available.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- JTNRFA001
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .