The Journal of Pain
Volume 11, Issue 3 , Pages 230-238 , March 2010

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

  • Barbara Rakel

      Affiliations

    • University of Iowa, College of Nursing, Iowa City, Iowa
    • Corresponding Author InformationAddress reprint requests to Barbara Rakel, RN, PhD, Assistant Professor, University of Iowa College of Nursing, 50 Newton Road, Iowa City, IA 52242.
  • ,
  • Nicholas Cooper

      Affiliations

    • University of Iowa, College of Medicine, Graduate Program in Physical Therapy & Rehabilitation Science, Iowa City, Iowa
  • ,
  • Heather J. Adams

      Affiliations

    • University of Iowa, College of Medicine, Graduate Program in Physical Therapy & Rehabilitation Science, Iowa City, Iowa
  • ,
  • Bryan R. Messer

      Affiliations

    • University of Iowa, College of Medicine, Graduate Program in Physical Therapy & Rehabilitation Science, Iowa City, Iowa
  • ,
  • Laura A. Frey Law

      Affiliations

    • University of Iowa, College of Medicine, Graduate Program in Physical Therapy & Rehabilitation Science, Iowa City, Iowa
  • ,
  • Douglas R. Dannen

      Affiliations

    • University of Iowa, College of Medicine, Graduate Program in Physical Therapy & Rehabilitation Science, Iowa City, Iowa
  • ,
  • Carrie A. Miller

      Affiliations

    • University of Iowa, College of Medicine, Graduate Program in Physical Therapy & Rehabilitation Science, Iowa City, Iowa
  • ,
  • Anya C. Polehna

      Affiliations

    • University of Iowa, College of Medicine, Graduate Program in Physical Therapy & Rehabilitation Science, Iowa City, Iowa
  • ,
  • Rachelle C. Ruggle

      Affiliations

    • University of Iowa, College of Medicine, Graduate Program in Physical Therapy & Rehabilitation Science, Iowa City, Iowa
  • ,
  • Carol G.T. Vance

      Affiliations

    • University of Iowa, College of Medicine, Graduate Program in Physical Therapy & Rehabilitation Science, Iowa City, Iowa
  • ,
  • Deirdre M. Walsh

      Affiliations

    • University of Ulster, Health and Rehabilitation Sciences Research Institute, Newtownabbey, Northern Ireland, UK
  • ,
  • Kathleen A. Sluka

      Affiliations

    • University of Iowa, College of Medicine, Graduate Program in Physical Therapy & Rehabilitation Science, Iowa City, Iowa

Received 24 February 2009 ,Revised 24 June 2009 ,Accepted 16 July 2009.

References 

  1. Aarskog R, Johnson MI, Demmink JH, Lofthus A, Iversen V, Lopes-Martins R, et al. Is mechanical pain threshold after transcutaneous electrical nerve stimulation (TENS) increased locally and unilaterally? A randomized placebo-controlled trial in healthy subjects. Physiother Res Int. 2007;12:251–263
  2. Agency for Health care Policy and Research: Agency for Health care Policy and Research. Acute pain management: Guideline technical report. 1 (95–0034),1995
  3. Bialosky JE, Bishop MD, Robinson ME, Barabas JA, George SZ. The influence of expectation on spinal manipulation induced hypoalgesia: An experimental study in normal subjects. BMC Musculoskelet Disord. 2008;9:19
  4. Bjerring P, Arendt-Nielsen L. Depth and duration of skin analgesia to needle insertion after topical application of EMLA cream. Br J Anaesth. 1990;64:173–177
  5. Bjordal JM, Johnson MI, Ljunggreen AE. Transcutaneous electrical nerve stimulation (TENS) can reduce postoperative analgesic consumption. A meta-analysis with assessment of optimal treatment parameters for postoperative pain. Eur J Pain. 2003;7:181–188
  6. Buonocore M, Camuzzini N. Increase of the heat pain threshold during and after high-frequency transcutaneous peripheral nerve stimulation in a group of normal subjects. Eura Medicophys. 2007;43:155–160
  7. Cheing GL, Hui-Chan CW. Analgesic effects of transcutaneous electrical nerve stimulation and interferential currents on heat pain in healthy subjects. J Rehabil Med. 2003;35:15–19
  8. Chesterton LS, Barlas P, Foster NE, Lundeberg T, Wright CC, Baxter GD. Sensory stimulation (TENS): Effects of parameter manipulation on mechanical pain thresholds in healthy human subjects. Pain. 2002;99:253–262
  9. Chesterton LS, Foster NE, Wright CC, Baxter GD, Barlas P. Effects of TENS frequency, intensity and stimulation site parameter manipulation on pressure pain thresholds in healthy human subjects. Pain. 2003;106:73–80
  10. Clarke P, Sproston K, Thomas R. An investigation into expectation-led interviewer effects in health surveys. Soc Sci Med. 2003;56:2221–2228
  11. Clavel-Chapelon F, Paoletti C, Benhamou S. Smoking cessation rates 4 years after treatment by nicotine gum and acupuncture. Prev Med. 1997;26:25–28
  12. Claydon LS, Chesterton LS, Barlas P, Sim J. Effects of simultaneous dual-site TENS stimulation on experimental pain. Eur J Pain. 2008;12:696–704
  13. Cowan S, McKenna J, McCrum-Gardner E, Johnson MI, Sluka KA, Walsh DM. An investigation of the hypoalgesic effects of TENS delivered by a glove electrode. J Pain. 2009;10:694–701
  14. Dean J, Bowsher D, Johnson MI. The effects of unilateral transcutaneous electrical nerve stimulation of the median nerve on bilateral somatosensory thresholds. Clin Physiol Funct Imaging. 2006;26:314–318
  15. Deyo RA, Walsh NE, Schoenfeld LS, Ramamurthy S. Can trials of physical treatments be blinded? The example of transcutaneous electrical nerve stimulation for chronic pain. Am J Phys Med Rehabil. 1990;69:6–10
  16. Diog GS, Simpson F: Randomization and allocation concealment: A practical guide for researchers. J Crit Care 20:187–191; discussion 191–3, 2005
  17. Drummond PD, de Silva-Rossdeutscher E. Transcutaneous iontophoresis of methadone provokes local flushing and thermal hyperalgesia. Inflamm Res. 2003;52:366–371
  18. Ekblom A, Hansson P. Thermal sensitivity is not changed by acute pain or afferent stimulation. J Neurol Neurosurg Psychiatry. 1987;50:1216–1220
  19. Fillingim RB, Ness TJ, Glover TL, Campbell CM, Price DD, Staud R. Experimental pain models reveal no sex differences in pentazocine analgesia in humans. Anesthesiology. 2004;100:1263–1270
  20. Garrison DW, Foreman RD. Classification of dorsal horn neurons based on somatic receptive fields in cats with intact and transected spinal cords: Neural plasticity. Brain Res. 1997;762:228–230
  21. Gibson W, Arendt-Nielsen L, Graven-Nielsen T. Referred pain and hyperalgesia in human tendon and muscle belly tissue. Pain. 2006;120:113–123
  22. Goffaux P, Redmond WJ, Rainville P, Marchand S. Descending analgesia—when the spine echoes what the brain expects. Pain. 2007;130:137–143
  23. Gopalkrishnan P, Sluka KA. Effect of varying frequency, intensity, and pulse duration of transcutaneous electrical nerve stimulation on primary hyperalgesia in inflamed rats. Arch Phys Med Rehabil. 2000;81:984–990
  24. Kalra A, Urban MO, Sluka KA. Blockade of opioid receptors in rostral ventral medulla prevents antihyperalgesia produced by transcutaneous electrical nerve stimulation (TENS). J Pharmacol Exp Ther. 2001;298:257–263
  25. Kosek E, Ekholm J, Hansson P. Pressure pain thresholds in different tissues in one body region. The influence of skin sensitivity in pressure algometry. Scand J Rehabil Med. 1999;31:89–93
  26. Ma YT, Sluka KA. Reduction in inflammation-induced sensitization of dorsal horn neurons by transcutaneous electrical nerve stimulation in anesthetized rats. Exp Brain Res. 2001;137:94–102
  27. Marchand S, Bushnell MC, Duncan GH. Modulation of heat pain perception by high frequency transcutaneous electrical nerve stimulation (TENS). Clin J Pain. 1991;7:122–129
  28. Moss P, Sluka K, Wright A. The initial effects of knee joint mobilization on osteoarthritic hyperalgesia. Manual Therapy. 2007;12:109–118
  29. Oosterhof J, Samwel HJ, de Boo TM, Wilder-Smith OH, Oostendorp RA, Crul BJ. Predicting outcome of TENS in chronic pain: A prospective, randomized, placebo controlled trial. Pain. 2008;136:11–20
  30. Palmer ST, Martin DJ, Steedman WM, Ravey J. Effects of electric stimulation on C and A delta fiber-mediated thermal perception thresholds. Arch Phys Med Rehabil. 2004;85:119–128
  31. Rakel B, Frantz R. Effectiveness of transcutaneous electrical nerve stimulation on postoperative pain with movement. J Pain. 2003;4:455–464
  32. Razavi M, Jansen GB. Effects of acupuncture and placebo TENS in addition to exercise in treatment of rotator cuff tendinitis. Clin Rehabil. 2004;18:872–878
  33. Robinson ME, Wise EA, Gagnon C, Fillingim RB, Price DD. Influences of gender role and anxiety on sex differences in temporal summation of pain. J Pain. 2004;5:77–82
  34. Scott DJ, Stohler CS, Egnatuk CM, Wang H, Koeppe RA, Zubieta JK. Placebo and nocebo effects are defined by opposite opioid and dopaminergic responses. Arch Gen Psychiatry. 2008;65:220–231
  35. Seymour RA. The use of pain scales in assessing the efficacy of analgesics in post-operative dental pain. Eur J Clin Pharmacol. 1982;23:441–444
  36. Sluka KA, Bailey K, Bogush J, Olson R, Ricketts A. Treatment with either high or low frequency TENS reduces the secondary hyperalgesia observed after injection of kaolin and carrageenan into the knee joint. Pain. 1998;77:97–102
  37. Sluka KA, Deacon M, Stibal A, Strissel S, Terpstra A. Spinal blockade of opioid receptors prevents the analgesia produced by TENS in arthritic rats. J Pharmacol Exp Ther. 1999;289:840–846
  38. Tong KC, Lo SK, Cheing GL. Alternating frequencies of transcutaneous electric nerve stimulation: Does it produce greater analgesic effects on mechanical and thermal pain thresholds?. Arch Phys Med Rehabil. 2007;88:1344–1349
  39. Wager TD, Scott DJ, Zubieta JK. Placebo effects on human mu-opioid activity during pain. Proc Natl Acad Sci USA. 2007;104:11056–11061
  40. Wang B, Tang J, White PF, Naruse R, Sloninsky A, Kariger R, et al. Effect of the intensity of transcutaneous acupoint electrical stimulation on the postoperative analgesic requirement. Anesth Analg. 1997;85:406–413
  41. Wang N, Hui-Chan C. Effects of acupoints TENS on heat pain threshold in normal subjects. Chin Med J (Engl). 2003;116:1864–1868
  42. Werner MU, Duun P, Kraemer O, Lassen B, Kehlet H. Arthroscopic knee surgery does not modify hyperalgesic responses to heat injury. Anesthesiology. 2003;99:1152–1157
  43. Wigley R. When is a placebo effect not an effect?. Clin Med. 2007;7:450–452
  44. Zubieta JK, Bueller JA, Jackson LR, Scott DJ, Xu Y, Koeppe RA, et al. Placebo effects mediated by endogenous opioid activity on mu-opioid receptors. J Neurosci. 2005;25:7754–7762

 Supported by NIH R03 NR010405, Congdon Faculty Development fund, and the Carver College of Medicine at the University of Iowa.

PII: S1526-5900(09)00655-5

doi: 10.1016/j.jpain.2009.07.007

The Journal of Pain
Volume 11, Issue 3 , Pages 230-238 , March 2010