A new transient sham TENS device allows for investigator blinding while delivering a true placebo treatment.
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 (> or =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.


CONCLUSIONS
This article presents the benefits of a new transient sham TENS device for use in prospective, randomized, clinical trials. This device facilitates blinding of subjects and investigators to eliminate expectation bias and determine the true efficacy of TENS for use in clinical populations.
Rakel
Barbara
B
University of Iowa, College of Nursing, Iowa City, Iowa. Barbara-rakel@uiowa.edu
Cooper
Nicholas
N
Adams
Heather J
HJ
Messer
Bryan R
BR
Frey Law
Laura A
LA
Dannen
Douglas R
DR
Miller
Carrie A
CA
Polehna
Anya C
AC
Ruggle
Rachelle C
RC
Vance
Carol G T
CG
Walsh
Deirdre M
DM
Sluka
Kathleen A
KA
D000328:Adult; D002986:Clinical Trials as Topic / Q000295:instrumentation* / Q000379:methods; D004311:Double-Blind Method; D004582:Electronics, Medical / Q000295:instrumentation* / Q000379:methods; D005260:Female; D006801:Humans; D008297:Male; D015588:Observer Variation; D010146:Pain / Q000503:physiopathology; D059408:Pain Management; D010147:Pain Measurement / Q000379:methods*; D015990:Placebo Effect; D010919:Placebos; D012107:Research Design; D004561:Transcutaneous Electric Nerve Stimulation / Q000379:methods*
D010919:Placebos