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Reductions in pain scores in patients with fibromyalgia who used a minimally invasive Angel Touch (AT-02) device for 8 weeks were found in meta-analyses to be comparable to those reported by patients treated with drugs for the condition, according to study results published in Pain Medicine.
A total of 44 patients with newly diagnosed fibromyalgia and fibromyalgia treated by medical intervention were enrolled from two sites in Japan. Patients who were taking concomitant agents for fibromyalgia pain relief or medications that were prohibited in this study (eg, pregabalin, tramadol) at the time of enrollment underwent a washout period (≥2 weeks), followed by a one-week run-in period. Numerical rating scale (NRS) scores were collected without device intervention over the course of a day, after which the sham control device (S-01) was applied to patients at ≥4 painful sites for approximately 10 minutes at each site, twice daily for 6 days.
The AT-02 was a minimally invasive device consisting of a controller and dual coil emitter; the latter simultaneously generated alternating magnetic fields (2kHz and 83.3MHz). The sham control device had an identical resin case and controller unit, but did not generate alternating magnetic fields.
Patients were subsequently randomly assigned to receive treatment with AT-02 (n=23) or S-01 (n=21), both of which were applied to ≥4 painful sites for approximately 10 minutes at each applicable site, twice a day for 8 weeks. NRS scores were assessed twice each day during treatment.
The change in NRS scores from baseline to 8 weeks was greater in the group who was treated with AT-02 vs S-01 (−0.94±1.33 vs −0.22±1.38, respectively; between-group comparison of change, −0.72; 95% CI, −1.39 to −0.04; P =.039). There was a trend toward a between-group difference in the NRS scores at 8 weeks that favored AT-02 (−0.73; 95% CI, −1.56-0.11; P =.086).
No adverse events/reactions were reported. Only one patient exchanged an AT-02 for another AT-02 device, but no malfunction of the index device was found.
Study limitations include the small sample size and the short duration of follow-up.
“Although a device with minimal adverse effects might be a preferable substitute for medications, an important future question is whether magnetic stimulation has an additive effect on background therapy,” noted the study authors.
Disclosures
The authors disclosed shares in the company that owns the researched device.
Reference
Oka H, Miki K, Kishita I, Kong DF, Uchida T. A multicenter, prospective, randomized, placebo-controlled, double-blind study of a novel pain management device, AT-02, in patients with fibromyalgia [published online June 5, 2019]. Pain Med. doi:10.1093/pm/pnz064
