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NCT03601949
Lateral Branch Cooled Radiofrequency Denervation vs. Conservative Therapy for Sacroiliac Joint Pain
NA trial testing SInergy Cooled Radiofrequency in Sacroiliac Joint Pain in 210 participants. Completed in 23 June 2022.
9 August 2021
Quick facts
| Lead sponsor | Avanos Medical |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 210 |
| Start date | 29 June 2018 |
| Primary completion | 9 August 2021 |
| Estimated completion | 23 June 2022 |
| Sites | 15 locations across United States |
Drugs / interventions tested
- SInergy Cooled Radiofrequency
- Medical Management — full drug profile →
Conditions studied
- Sacroiliac Joint Pain — all drugs for Sacroiliac Joint Pain →
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):
-
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 -
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
Verify or expand the search:
- PubMed search for NCT03601949
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Avanos Medical trials
Trials by the same sponsor.
- NCT04145011 — Coolief Cooled Radiofrequency vs. Conventional Radiofrequency to Manage OA Knee Pain · NA · completed
- NCT03381248 — Cooled Radiofrequency vs. Hyaluronic Acid to Manage Knee Pain · NA · completed
- NCT03368976 — PACMAN Ultrasound Recording Data Collection · terminated
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03601949 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Avanos Medical
- Last refreshed: 22 March 2023
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.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing