A New Transient Sham TENS Device Allows for Investigator Blinding While Delivering a True Placebo Treatment

Barbara Rakel, Nicholas Cooper, Heather J. Adams, Bryan R. Messer, Laura A. Frey Law, Douglas R. Dannen, Carrie A. Miller, Anya C. Polehna, Rachelle C. Ruggle, Carol G. T. Vance, Deirdre M. Walsh, Kathleen A. Sluka

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    72 Citations (Scopus)

    Abstract

    This study compared a new transient sham transcutaneous electrical nerve stimulation(TENS) that delivers current for 45 seconds to an inactive sham and active TENS to determine the degree of blinding and influence on pain reduction. Pressure-pain thresholds (PPT), heat-pain thresholds (HPT), and pain intensities to tonic heat and pressure were measured in 69 healthy adults before and after randomization. Allocation investigators and subjects were asked to identify the treatment administered. The transient sham blinded investigators 100% of the time and 40% of subjects compared to the inactive sham that blinded investigators 0% of the time and 21% of subjects. Investigators and subjects were blinded only 7% and 13% of the time, respectively, with active TENS. Neither placebo treatment resulted in significant changes in PPT, HPT, or pain intensities. Subjects using higher active TENS amplitudes (≥17 mAs) had significantly higher PPTs and lower pain intensities to tonic pressure than subjects using lower amplitudes (
    Original languageEnglish
    Pages (from-to)230-238
    JournalJournal of Pain
    Volume11
    Issue number3
    DOIs
    Publication statusPublished - Mar 2010

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  • Cite this

    Rakel, B., Cooper, N., Adams, H. J., Messer, B. R., Frey Law, L. A., Dannen, D. R., Miller, C. A., Polehna, A. C., Ruggle, R. C., Vance, C. G. T., Walsh, D. M., & Sluka, K. A. (2010). A New Transient Sham TENS Device Allows for Investigator Blinding While Delivering a True Placebo Treatment. Journal of Pain, 11(3), 230-238. https://doi.org/10.1016/j.jpain.2009.07.007