Phase I/II Multi-Institutional Study of Percutaneous Radiofrequency Ablation for Painful Osteoid Osteoma (JIVROSG-0704)

Masaya Miyazaki, Yasuaki Arai, Akira Myoui, Hideo Gobara, Miyuki Sone, Daniel I. Rosenthal, Yoshito Tsushima, Susumu Kanazawa, Shigeru Ehara, Keigo Endo

Research output: Contribution to journalArticle

16 Citations (Scopus)

Abstract

Purpose: This multicenter prospective study was conducted to evaluate the safety and efficacy of percutaneous radiofrequency ablation (RFA) for painful osteoid osteoma (OO). Materials and Methods: Patients with OO (femur: n = 17, tibia: n = 2, humerus: n = 1, rib: n = 1) were enrolled and treated with RFA. In phase I, nine patients were evaluated for safety. In phase II, 12 patients were accrued, and an intent-to-treat analysis was performed on all patients. The primary endpoint was to evaluate the treatment safety. The secondary endpoint was to evaluate the efficacy for pain relief by the visual analogue scale (VAS) at 4 weeks after RFA. Treatment efficacy was classified as significantly effective (SE) when VAS score decreased by ≥5 or score was <2, moderately effective when VAS score decreased by <5–≥2 and score was ≥2, and not effective (NE) when VAS score decreased by <2 or score was increased. Cases where the need for analgesics increased after treatment were also NE. Results: RFA procedures were completed in all patients. Minor adverse effects (AEs) were observed as 4.8–14.3 % in 12 patients, and no major AEs were observed. Mean VAS score was 7.1 before treatment, 1.6 at 1 week, 0.3 at 4 weeks, and 0.2 at 3 months. All procedures were classified as SE. Pain recurrence was not noted in any patient during follow-up (mean: 15.1 months). Conclusion: RFA is a safe, highly effective, and fast-acting treatment for painful extraspinal OO. Future studies with a greater number of patients are needed.

Original languageEnglish
Pages (from-to)1464-1470
Number of pages7
JournalCardioVascular and Interventional Radiology
Volume39
Issue number10
DOIs
Publication statusPublished - Oct 1 2016

Fingerprint

Osteoid Osteoma
Visual Analog Scale
Safety
Humerus
Ribs
Pain Measurement
Therapeutics
Tibia
Femur
Multicenter Studies
Analgesics
Prospective Studies
Recurrence
Pain

Keywords

  • Clinical trial
  • Osteoid osteoma
  • Radiofrequency ablation

ASJC Scopus subject areas

  • Medicine(all)
  • Radiology Nuclear Medicine and imaging
  • Cardiology and Cardiovascular Medicine

Cite this

Phase I/II Multi-Institutional Study of Percutaneous Radiofrequency Ablation for Painful Osteoid Osteoma (JIVROSG-0704). / Miyazaki, Masaya; Arai, Yasuaki; Myoui, Akira; Gobara, Hideo; Sone, Miyuki; Rosenthal, Daniel I.; Tsushima, Yoshito; Kanazawa, Susumu; Ehara, Shigeru; Endo, Keigo.

In: CardioVascular and Interventional Radiology, Vol. 39, No. 10, 01.10.2016, p. 1464-1470.

Research output: Contribution to journalArticle

Miyazaki, Masaya ; Arai, Yasuaki ; Myoui, Akira ; Gobara, Hideo ; Sone, Miyuki ; Rosenthal, Daniel I. ; Tsushima, Yoshito ; Kanazawa, Susumu ; Ehara, Shigeru ; Endo, Keigo. / Phase I/II Multi-Institutional Study of Percutaneous Radiofrequency Ablation for Painful Osteoid Osteoma (JIVROSG-0704). In: CardioVascular and Interventional Radiology. 2016 ; Vol. 39, No. 10. pp. 1464-1470.
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abstract = "Purpose: This multicenter prospective study was conducted to evaluate the safety and efficacy of percutaneous radiofrequency ablation (RFA) for painful osteoid osteoma (OO). Materials and Methods: Patients with OO (femur: n = 17, tibia: n = 2, humerus: n = 1, rib: n = 1) were enrolled and treated with RFA. In phase I, nine patients were evaluated for safety. In phase II, 12 patients were accrued, and an intent-to-treat analysis was performed on all patients. The primary endpoint was to evaluate the treatment safety. The secondary endpoint was to evaluate the efficacy for pain relief by the visual analogue scale (VAS) at 4 weeks after RFA. Treatment efficacy was classified as significantly effective (SE) when VAS score decreased by ≥5 or score was <2, moderately effective when VAS score decreased by <5–≥2 and score was ≥2, and not effective (NE) when VAS score decreased by <2 or score was increased. Cases where the need for analgesics increased after treatment were also NE. Results: RFA procedures were completed in all patients. Minor adverse effects (AEs) were observed as 4.8–14.3 {\%} in 12 patients, and no major AEs were observed. Mean VAS score was 7.1 before treatment, 1.6 at 1 week, 0.3 at 4 weeks, and 0.2 at 3 months. All procedures were classified as SE. Pain recurrence was not noted in any patient during follow-up (mean: 15.1 months). Conclusion: RFA is a safe, highly effective, and fast-acting treatment for painful extraspinal OO. Future studies with a greater number of patients are needed.",
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AU - Miyazaki, Masaya

AU - Arai, Yasuaki

AU - Myoui, Akira

AU - Gobara, Hideo

AU - Sone, Miyuki

AU - Rosenthal, Daniel I.

AU - Tsushima, Yoshito

AU - Kanazawa, Susumu

AU - Ehara, Shigeru

AU - Endo, Keigo

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N2 - Purpose: This multicenter prospective study was conducted to evaluate the safety and efficacy of percutaneous radiofrequency ablation (RFA) for painful osteoid osteoma (OO). Materials and Methods: Patients with OO (femur: n = 17, tibia: n = 2, humerus: n = 1, rib: n = 1) were enrolled and treated with RFA. In phase I, nine patients were evaluated for safety. In phase II, 12 patients were accrued, and an intent-to-treat analysis was performed on all patients. The primary endpoint was to evaluate the treatment safety. The secondary endpoint was to evaluate the efficacy for pain relief by the visual analogue scale (VAS) at 4 weeks after RFA. Treatment efficacy was classified as significantly effective (SE) when VAS score decreased by ≥5 or score was <2, moderately effective when VAS score decreased by <5–≥2 and score was ≥2, and not effective (NE) when VAS score decreased by <2 or score was increased. Cases where the need for analgesics increased after treatment were also NE. Results: RFA procedures were completed in all patients. Minor adverse effects (AEs) were observed as 4.8–14.3 % in 12 patients, and no major AEs were observed. Mean VAS score was 7.1 before treatment, 1.6 at 1 week, 0.3 at 4 weeks, and 0.2 at 3 months. All procedures were classified as SE. Pain recurrence was not noted in any patient during follow-up (mean: 15.1 months). Conclusion: RFA is a safe, highly effective, and fast-acting treatment for painful extraspinal OO. Future studies with a greater number of patients are needed.

AB - Purpose: This multicenter prospective study was conducted to evaluate the safety and efficacy of percutaneous radiofrequency ablation (RFA) for painful osteoid osteoma (OO). Materials and Methods: Patients with OO (femur: n = 17, tibia: n = 2, humerus: n = 1, rib: n = 1) were enrolled and treated with RFA. In phase I, nine patients were evaluated for safety. In phase II, 12 patients were accrued, and an intent-to-treat analysis was performed on all patients. The primary endpoint was to evaluate the treatment safety. The secondary endpoint was to evaluate the efficacy for pain relief by the visual analogue scale (VAS) at 4 weeks after RFA. Treatment efficacy was classified as significantly effective (SE) when VAS score decreased by ≥5 or score was <2, moderately effective when VAS score decreased by <5–≥2 and score was ≥2, and not effective (NE) when VAS score decreased by <2 or score was increased. Cases where the need for analgesics increased after treatment were also NE. Results: RFA procedures were completed in all patients. Minor adverse effects (AEs) were observed as 4.8–14.3 % in 12 patients, and no major AEs were observed. Mean VAS score was 7.1 before treatment, 1.6 at 1 week, 0.3 at 4 weeks, and 0.2 at 3 months. All procedures were classified as SE. Pain recurrence was not noted in any patient during follow-up (mean: 15.1 months). Conclusion: RFA is a safe, highly effective, and fast-acting treatment for painful extraspinal OO. Future studies with a greater number of patients are needed.

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