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A Multicenter, Prospective, Randomized, Placebo-Controlled, Double-Blind Study of a Novel Pain Management Device, AT-02, in Patients with Fibromyalgia.

Publication ,  Journal Article
Oka, H; Miki, K; Kishita, I; Kong, DF; Uchida, T
Published in: Pain Med
February 1, 2020

OBJECTIVES: Existing treatments for fibromyalgia have limited efficacy, and only a minority of individuals clinically respond to any single intervention. This study was a prospective, multicenter, randomized, double-blind, controlled clinical trial to evaluate the feasibility of alternating magnetic field therapy in fibromyalgia patients by comparing the Angel Touch device (AT-02) with a sham control (S-01). METHODS: Two sites enrolled 44 subjects with diagnosed fibromyalgia. After informed consent, subjects taking prohibited concomitant drugs underwent a washout period of two or more weeks. All subjects then began a one-week run-in period. Numerical rating scale (NRS) pain scores were collected without device intervention for one day, followed by S-01 application to four or more painful sites for 10 minutes at each site, twice daily for six days. Subjects were then randomized to AT-02 or S-01, applied to four or more painful sites for 10 minutes at each site, twice daily for eight weeks. NRS scores were obtained twice daily during the entire treatment period. RESULTS: The primary end point (change in NRS ± SD at week 8 vs baseline) was -0.94 ± 1.33 in the AT-02 group and -0.22 ± 1.38 in the S-01 group. A trend toward a between-group difference in eight-week NRS scores favored the AT-02 group (-0.73, 95% confidence interval = -1.56 to 0.11, P = 0.086). An adjusted repeated measure analysis detected a significant difference in NRS scores (P = 0.039). CONCLUSIONS: The reduction in NRS scores for AT-02 relative to sham was comparable to reductions observed in meta-analyses of fibromyalgia drug therapy. The unadjusted results and the persistence of the pain score reductions remain encouraging.

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Published In

Pain Med

DOI

EISSN

1526-4637

Publication Date

February 1, 2020

Volume

21

Issue

2

Start / End Page

326 / 332

Location

England

Related Subject Headings

  • Treatment Outcome
  • Pain Management
  • Middle Aged
  • Male
  • Magnetic Field Therapy
  • Humans
  • Fibromyalgia
  • Female
  • Double-Blind Method
  • Anesthesiology
 

Citation

APA
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Oka, H., Miki, K., Kishita, I., Kong, D. F., & Uchida, T. (2020). A Multicenter, Prospective, Randomized, Placebo-Controlled, Double-Blind Study of a Novel Pain Management Device, AT-02, in Patients with Fibromyalgia. Pain Med, 21(2), 326–332. https://doi.org/10.1093/pm/pnz064
Oka, Hiroshi, Kenji Miki, Iwao Kishita, David F. Kong, and Takahiro Uchida. “A Multicenter, Prospective, Randomized, Placebo-Controlled, Double-Blind Study of a Novel Pain Management Device, AT-02, in Patients with Fibromyalgia.Pain Med 21, no. 2 (February 1, 2020): 326–32. https://doi.org/10.1093/pm/pnz064.
Oka, Hiroshi, et al. “A Multicenter, Prospective, Randomized, Placebo-Controlled, Double-Blind Study of a Novel Pain Management Device, AT-02, in Patients with Fibromyalgia.Pain Med, vol. 21, no. 2, Feb. 2020, pp. 326–32. Pubmed, doi:10.1093/pm/pnz064.
Journal cover image

Published In

Pain Med

DOI

EISSN

1526-4637

Publication Date

February 1, 2020

Volume

21

Issue

2

Start / End Page

326 / 332

Location

England

Related Subject Headings

  • Treatment Outcome
  • Pain Management
  • Middle Aged
  • Male
  • Magnetic Field Therapy
  • Humans
  • Fibromyalgia
  • Female
  • Double-Blind Method
  • Anesthesiology