Fluoroscopy-guided high-intensity focused ultrasound neurotomy of the lumbar zygapophyseal joints : a prospective, open-label study
© American Society of Regional Anesthesia & Pain Medicine 2024. Re-use permitted under CC BY-NC. No commercial re-use. Published by BMJ..
OBJECTIVE: The objective of this study is to investigate safety and effectiveness of a fluoroscopy-guided high-intensity focused ultrasound (HIFU) system for thermal ablation of the lumbar medial branch nerves.
METHODS: This dual center prospective cohort study enrolled 30 participants with lumbar zygapophyseal joint syndrome. Each participant previously had a positive response to either a single diagnostic analgesic block or radiofrequency ablation (RFA). The primary effectiveness outcome was individual responder rate, defined as a reduction of two points or more on the pain intensity numerical rating scale without an increase in opioid intake, or a reduction in opioid intake without an increase in pain at 6 months after the intervention. The primary safety outcome was procedure-related or device-related adverse events (AEs). Secondary outcome variables included MRI evidence of tissue ablation, Oswestry Disability Index, 12-Item Short Form Health Survey, Brief Pain Inventory, and Patient Global Impression of Change.
RESULTS: The individual responder rate was 89.7% at 2 days, 89.7% at 7 days, 72.4% at 14 days, 82.1% at 30 days, 59.3% at 90 days and 82.6% at 180 days. The average Numeric Rating Scale for pain severity decreased from 7.1 at baseline to 3.0 (N=29) after 2 days, 3.0 (N=29) after 7 days, 3.1 (N=29) after 14 days, 3.2 (N=28) after 30 days, 4.3 (N=27) after 90 days, and 3.3 (N=23) after 180 days. All participants tolerated the procedure well with no significant side effects or complications.
CONCLUSIONS: Fluoroscopy-guided HIFU neurotomy achieved clinical responses comparable with RFA, and there were no significant device-related or procedure-related AEs.
TRIAL REGISTRATION NUMBER: NCT04129034.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - year:2024 |
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| Enthalten in: |
Regional anesthesia and pain medicine - (2024) vom: 05. Apr. |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Gofeld, Michael [VerfasserIn] |
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| Links: |
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| Themen: |
Back Pain |
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| Anmerkungen: |
Date Revised 05.04.2024 published: Print-Electronic ClinicalTrials.gov: NCT04129034 Citation Status Publisher |
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| doi: |
10.1136/rapm-2024-105345 |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM370697464 |
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| 100 | 1 | |a Gofeld, Michael |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Fluoroscopy-guided high-intensity focused ultrasound neurotomy of the lumbar zygapophyseal joints |b a prospective, open-label study |
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| 500 | |a Citation Status Publisher | ||
| 520 | |a © American Society of Regional Anesthesia & Pain Medicine 2024. Re-use permitted under CC BY-NC. No commercial re-use. Published by BMJ. | ||
| 520 | |a OBJECTIVE: The objective of this study is to investigate safety and effectiveness of a fluoroscopy-guided high-intensity focused ultrasound (HIFU) system for thermal ablation of the lumbar medial branch nerves | ||
| 520 | |a METHODS: This dual center prospective cohort study enrolled 30 participants with lumbar zygapophyseal joint syndrome. Each participant previously had a positive response to either a single diagnostic analgesic block or radiofrequency ablation (RFA). The primary effectiveness outcome was individual responder rate, defined as a reduction of two points or more on the pain intensity numerical rating scale without an increase in opioid intake, or a reduction in opioid intake without an increase in pain at 6 months after the intervention. The primary safety outcome was procedure-related or device-related adverse events (AEs). Secondary outcome variables included MRI evidence of tissue ablation, Oswestry Disability Index, 12-Item Short Form Health Survey, Brief Pain Inventory, and Patient Global Impression of Change | ||
| 520 | |a RESULTS: The individual responder rate was 89.7% at 2 days, 89.7% at 7 days, 72.4% at 14 days, 82.1% at 30 days, 59.3% at 90 days and 82.6% at 180 days. The average Numeric Rating Scale for pain severity decreased from 7.1 at baseline to 3.0 (N=29) after 2 days, 3.0 (N=29) after 7 days, 3.1 (N=29) after 14 days, 3.2 (N=28) after 30 days, 4.3 (N=27) after 90 days, and 3.3 (N=23) after 180 days. All participants tolerated the procedure well with no significant side effects or complications | ||
| 520 | |a CONCLUSIONS: Fluoroscopy-guided HIFU neurotomy achieved clinical responses comparable with RFA, and there were no significant device-related or procedure-related AEs | ||
| 520 | |a TRIAL REGISTRATION NUMBER: NCT04129034 | ||
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| 650 | 4 | |a Pain Management | |
| 650 | 4 | |a Pain Measurement | |
| 650 | 4 | |a TECHNOLOGY | |
| 650 | 4 | |a Treatment Outcome | |
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| 700 | 1 | |a Bhatia, Anuj |e verfasserin |4 aut | |
| 700 | 1 | |a Djuric, Vladimir |e verfasserin |4 aut | |
| 700 | 1 | |a Leblang, Suzanne |e verfasserin |4 aut | |
| 700 | 1 | |a Rebhun, Niv |e verfasserin |4 aut | |
| 700 | 1 | |a Aginsky, Ron |e verfasserin |4 aut | |
| 700 | 1 | |a Miller, Eric |e verfasserin |4 aut | |
| 700 | 1 | |a Skoglind, Brian |e verfasserin |4 aut | |
| 700 | 1 | |a Hananel, Arik |e verfasserin |4 aut | |
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