| Summary: | Robert N Jamison,1 Robert R Edwards,1 Samantha Curran,1 Limeng Wan,1 Edgar L Ross,1 Christopher J Gilligan,1 Shai N Gozani2 1Department of Anesthesiology, Perioperative and Pain Medicine, Harvard Medical School, Brigham & Women’s Hospital, Chestnut Hill, MA, USA; 2NeuroMetrix, Inc., Woburn, MA, USACorrespondence: Shai N GozaniNeuroMetrix, Inc., 4b Gill St., Woburn, MA, 01801, USATel +1 781 314 2789Fax +1 781 890 1556Email gozani@neurometrix.comPurpose: Fibromyalgia is a chronic condition characterized by widespread pain and interference with daily activities. The aim of this study is to assess the benefit of transcutaneous electrical nerve stimulation (TENS) for persons diagnosed with fibromyalgia.Patients and Methods: Adults meeting diagnostic criteria for fibromyalgia were randomized in a double-blind trial to receive either an active (n=62) or sham (n=57) wearable TENS device for 3-months. Subjects were classified as having lower or higher pain sensitivity by Quantitative Sensory Testing (QST). Patient Global Impression of Change (PGIC, primary outcome) and secondary efficacy measures including Fibromyalgia Impact Questionnaire (FIQR), Brief Pain Inventory (BPI) and painDETECT questionnaire (PDQ) were assessed at baseline, 6-weeks and 3-months. Treatment effects were determined by a mixed model for repeated measures (MMRM) analysis of the intention-to-treat (ITT) population (N=119). A pre-specified subgroup analysis of pain sensitivity was conducted using an interaction term in the model.Results: No differences were found between active and sham treatment on PGIC scores at 3-months (0.34, 95% CI [− 0.37, 1.04], p=0.351) in the ITT population. However, in subjects with higher pain sensitivity (n=60), PGIC was significantly greater for active treatment compared to sham (1.19, 95% CI [0.24, 2.13], p=0.014). FIQR total score (− 7.47, 95% CI [− 12.46, − 2.48], p=0.003), FIQR pain item (− 0.62, 95% CI [− 1.17, − 0.06], p=0.029), BPI Interference (− 0.70, 95% CI [− 1.30, − 0.11], p=0.021) and PDQ (− 1.69, 95% CI [− 3.20, − 0.18], p=0.028) exhibited significant improvements for active treatment compared to sham in the ITT population. Analgesics use was stable and comparable in both groups.Conclusion: This study demonstrated modest treatment effects of reduced disease impact, pain and functional impairment from wearable TENS in individuals with fibromyalgia. Subjects with higher pain sensitivity exhibited larger treatment effects than those with lower pain sensitivity. Wearable TENS may be a safe treatment option for people with fibromyalgia.Clinicaltrials.gov Registration: NCT03714425.Keywords: fibromyalgia, wearable, transcutaneous electrical nerve stimulation, neuromodulation, non-pharmacological treatment, clinical trial
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