- Alternating magnetic field therapy (Angel Touch device, AT-02) modestly reduces pain in patients with fibromyalgia in a double-blind randomized, sham-controlled trial.
- Study design excluded patients with high likelihood of placebo effect.
Why this matters
- Benefits were comparable in magnitude to that of fibromyalgia drug therapies.
- Multicenter, randomized, sham-controlled, double-blind trial of AT-02 vs S-01 (sham alternating magnetic field therapy; n=44).
- Study began with a 2-week wash-out period of fibromyalgia medications, followed by a 1-week run-in period of S-01 exposure to all subjects. Subjects with ≥30% pain improvement in the run-in period were excluded from randomization (to minimize subsequent placebo effect).
- Subjects were then randomized to AT-02 or S-01 twice daily for 8 weeks (applied to 4 or more painful sites for 10 minutes at each site).
- The primary outcome was change in Numeric Rating Scale (NRS)±standard deviation at week 8 vs mean NRS during run-in period.
- Funding: PEACE OF MIND Co. Ltd.
- The AT-02 group had greater reduction in NRS score at 8 weeks vs run-in period (−0.94±1.33 vs −0.22±1.38 in the S-01 group).
- Findings showed a trend toward a between-group difference (−0.73; P=.0859) and a significant difference in the adjusted repeated measure analysis (−0.72; P=.0386).
- Small sample sizes.