Effectiveness of fixed-site high-frequency transcutaneous electrical nerve stimulation in chronic pain: a large-scale, observational study
Received 11 November 2017
Accepted for publication 12 February 2018
Published 9 April 2018 Volume 2018:11 Pages 703—714
Checked for plagiarism Yes
Review by Single-blind
Peer reviewers approved by Dr Colin Mak
Peer reviewer comments 2
Editor who approved publication: Dr E. Alfonso Romero-Sandoval
Xuan Kong, Shai N Gozani
NeuroMetrix, Inc., Waltham, MA, USA
Objective: The objective of this study was to assess the effectiveness of fixed-site high-frequency transcutaneous electrical nerve stimulation (FS-TENS) in a real-world chronic pain sample.
Background: There is a need for nonpharmacological treatment options for chronic pain. FS-TENS improved multisite chronic pain in a previous interventional study. Large observational studies are needed to further characterize its effectiveness.
Methods: This retrospective observational cohort study examined changes in chronic pain measures following 60 days of FS-TENS use. The study data were obtained from FS-TENS users who uploaded their device utilization and clinical data to an online database. The primary outcome measures were changes in pain intensity and pain interference with sleep, activity, and mood on an 11-point numerical rating scale. Dose–response associations were evaluated by stratifying subjects into low (≤30 days), intermediate (31–56 days), and high (≥57 days) utilization subgroups. FS-TENS effectiveness was quantified by baseline to follow-up group differences and a responder analysis (≥30% improvement in pain intensity or ≥2-point improvement in pain interference domains).
Results: Utilization and clinical data were collected from 11,900 people using FS-TENS for chronic pain, with 713 device users meeting the inclusion and exclusion criteria. Study subjects were generally older, overweight adults. Subjects reported multisite pain with a mean of 4.8 (standard deviation [SD] 2.5) pain sites. A total of 97.2% of subjects identified low back and/or lower extremity pain, and 72.9% of subjects reported upper body pain. All pain measures exhibited statistically significant group differences from baseline to 60-day follow-up. The largest changes were pain interference with activity (−0.99±2.69 points) and mood (−1.02±2.78 points). A total of 48.7% of subjects exhibited a clinically meaningful reduction in pain interference with activity or mood. This proportion increased to 57.1% for the high utilization subgroup.
Conclusion: FS-TENS is a practical option for treating multisite chronic pain. The greatest impact is on pain interference with activity and mood. FS-TENS utilization and effectiveness exhibit a dose–response association, suggesting that daily use maximizes pain relief.
Keywords: chronic pain, multisite, widespread, transcutaneous electrical nerve stimulation, wearable, pain relief devices
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