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NCT03601949

Lateral Branch Cooled Radiofrequency Denervation vs. Conservative Therapy for Sacroiliac Joint Pain

Completed NA Last updated 22 March 2023
What this trial tests

NA trial testing SInergy Cooled Radiofrequency in Sacroiliac Joint Pain in 210 participants. Completed in 23 June 2022.

Timeline
29 June 2018
Primary endpoint
9 August 2021
23 June 2022

Quick facts

Lead sponsorAvanos Medical
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment210
Start date29 June 2018
Primary completion9 August 2021
Estimated completion23 June 2022
Sites15 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Avanos Medical

Who can join

Adults 21 to 110, any sex, with Sacroiliac Joint Pain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a prospective, randomized, controlled, multi-center clinical study. Approximately 208 subjects will be enrolled at approximately 12-15 active duty military, veterans' care, and civilian sites. Eligible subjects will be randomized in 1:1 ratio to receive either Sacroiliac denervation using CRF (treatment group) or standard medical management ("SMM," control group).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Cooled radiofrequency ablation versus standard medical management for chronic sacroiliac joint pain: a multicenter, randomized comparative effectiveness study.
    Cohen SP, Kapural L, Kohan L, Li S, et al · · 2024 · cited 13× · PMID 37407279 · DOI 10.1136/rapm-2023-104568
  2. Cooled radiofrequency ablation provides extended clinical utility in the management of chronic sacroiliac joint pain: 12-month follow-up results from the observational phase of a randomized, multicenter, comparative-effectiveness crossover study.
    Cohen SP, Kapural L, Kohan L, Li S, et al · · 2026 · cited 3× · PMID 40089310 · DOI 10.1136/rapm-2024-106315

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Other Avanos Medical trials

Trials by the same sponsor.

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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03601949.

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