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

doi:10.1016/j.jpain.2009.07.007

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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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 language	English
Pages (from-to)	230-238
Journal	Journal of Pain
Volume	11
Issue number	3
DOIs	https://doi.org/10.1016/j.jpain.2009.07.007
Publication status	Published (in print/issue) - Mar 2010

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

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 (",

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

year = "2010",

month = mar,

doi = "10.1016/j.jpain.2009.07.007",

language = "English",

volume = "11",

pages = "230--238",

journal = "Journal of Pain",

publisher = "Elsevier",

number = "3",

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AU - Rakel, Barbara

AU - Cooper, Nicholas

AU - Adams, Heather J.

AU - Messer, Bryan R.

AU - Frey Law, Laura A.

AU - Dannen, Douglas R.

AU - Miller, Carrie A.

AU - Polehna, Anya C.

AU - Ruggle, Rachelle C.

AU - Vance, Carol G. T.

AU - Walsh, Deirdre M.

AU - Sluka, Kathleen A.

PY - 2010/3

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N2 - 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 (

AB - 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 (

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DO - 10.1016/j.jpain.2009.07.007

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SP - 230

EP - 238

JO - Journal of Pain

JF - Journal of Pain

IS - 3

ER -

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

Abstract

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