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

Rakel, Barbara, Cooper, Nicholas, Adams, Heather J., Messer, Bryan R., Frey Law, Laura A., Dannen, Douglas R., Miller, Carrie A., Polehna, Anya C., Ruggle, Rachelle C., Vance, Carol G. T., Walsh, Deirdre M. and Sluka, Kathleen A. (2010) A New Transient Sham TENS Device Allows for Investigator Blinding While Delivering a True Placebo Treatment. Journal of Pain, 11 (3). pp. 230-238. [Journal article]

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DOI: 10.1016/j.jpain.2009.07.007


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 (<17 mAs). HPTs and pain intensities to tonic heat were not significantly changed. The transient TENS completely blinds investigators to treatment and does not reduce pain, thereby providing a true placebo treatment.

Item Type:Journal article
Faculties and Schools:Faculty of Life and Health Sciences
Faculty of Life and Health Sciences > School of Health Sciences
Research Institutes and Groups:Institute of Nursing and Health Research > Centre for Health and Rehabilitation Technologies
ID Code:12579
Deposited By: Professor Deirdre Walsh
Deposited On:02 Apr 2010 09:13
Last Modified:28 Feb 2012 12:25

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