- Placebo Park Sham Research Needle & Device
- Park Sham Device Research Tools
- Park Sham Placebo Acupuncture Device
1. Introduction to Park Sham Device
Since the Park Sham Device was first developed in 1999 1, several teams of researchers in UK2, 3, Japan 4, Korea 5 and USA 6 tested its credibility and validity in various settings. Based on these findings, over the past 10 years, it has been frequently used in research projects often funded by government agencies including US National Institute of Health. 7-10
Park and the colleagues, who developed, state that this device is indistinguishable from the same procedure using real needles in acupuncture naïve subjects, and inactive, where the specific needle sensation is taken as a surrogate measure of activity. 2 However, due to the nature of minimal physiological activity required to achieve successful subject blinding in acupuncture trial, they emphatically call for caution in application of sham acupuncture control 11 and interpretation of the findings. 12 For this reason, Park is keen to call this a bona fide version of sham control rather than final version.
- Park J. et al. Development of a new sham needle, Acupunct Med 17 (1999), pp. 110–112.
- Park J. et al., Validating a new nonpenetrating sham acupuncture device: two randomised controlled trials, Acupunct Med 20 (2002), pp. 168–174.
- Whale CA et al. Pilot study to assess the credibility of acupuncture in acute exacerbations of chronic obstructive pulmonary disease. Acupunct Med. 2009 Mar;27(1):13-5.
- Tsukayama H et al. Factors that influence the applicability of sham needle in acupuncture trials: two randomized, single-blind, crossover trials with acupuncture-experienced subjects. Clin J Pain. 2006 May;22(4):346-9.
- Chae Y et al. The neural substrates of verum acupuncture compared to non-penetrating placebo needle: an fMRI study. Neurosci Lett. 2009 Jan 30;450(2):80-4.
- Tan CW et al. Discrimination of real and sham acupuncture needles using the Park sham device: a preliminary study, Arch Phys Med Rehabil 90 (2009), pp. 2141–2145.
- Downs NM et al. The effect of real and sham acupuncture on thermal sensation and thermal pain thresholds. Arch Phys Med Rehabil 2005;86:1252-7.
- Park J, et al. Acupuncture for subacute stroke rehabilitation: a Sham-controlled, subject- and assessor-blind, randomized trial. Arch Intern Med. 2005 Sep 26;165(17):2026-31.
- Smith P et al. The efficacy of acupuncture in the treatment of temporomandibular joint myofascial pain: a randomised controlled trial. J Dent. 2007 Mar;35(3):259-67.
- Kennedy S et al. Acupuncture for acute non-specific low back pain: a pilot randomised non-penetrating sham controlled trial. Complement Ther Med. 2008 Jun;16(3):139-46.
- Park J. Sham needle control needs careful approach. Pain. 2004 May;109(1-2):195-6
- Park JJ. Developing and validating a sham acupuncture needle. Acupunct Med. 2009 Sep;27(3):93.
2. What is Park Sham Device?
The Park Sham Device consists of 2 plastic tubes, one of which slides into the other. These are attached to a base, which is formed of a flat disc. On the bottom of this is a double sided sticky circle to facilitate placement on the skin. All the constituent part are manufactured in the Republic of Korea.
Acupuncture needles are supplied with the Park Sham Device. %0% of these are blunt sham needles. The others are normal acupuncture needles. These are registered in the European Union as CE 0120 and in the United States of America as FDA License No.263.
The intended use is investigation of the efficacy of acupuncture in the treatment of illness and pain.
Final disposition. These will be disposed of after use in the usual way for used sharp medical products. They will be collected in a suitable “sharps container” and incinerated by a company licensed to deal with this kind of waste.
3. Instructions - How to use Park Sham Device.
Currently either real or sham needles are packed in a single guide tube in a blister package. To avoid compromising the sterilisation you could peel off only the top of the package to expose the handle of the needle.
Then introduce that handle through the bottom of the plastic flange. After introducing the handle you tilt the needle and Park tube over to allow the needle to slide down to the other end of the tube. Then you will be able to hold the needle handle together with the top end of the Park tube.
After this, peel off the cover of the double-sided sticky tape and place the device on the skin while keeping the needle handle projecting about 5 mm from the top of the Park tube. Then tap the needle gently to insert it about 5 mm followed by moving down the upper telescopic guide tube to allow sufficient exposure of the handle for manipulation of the needle. Manipulate the needle as desired.
To remove: first take out the needle and dispose of it safely, then peel the flange from the skin, with the guide tube in place. Doing this quickly will minimise discomfort.
Smith P, Mosscrop D, S Davies, Sloan P, Al-Ani Z. The efficacy of acupuncture in the treatment of temporomandibular joint myofascial pain: A randomised controlled trial. Journal of Dentistry 2007; 35: 259-267.
Park J, White A, Stevinson C, Ernst E, James M. Validating a new non-penetrating sham acupuncture device: two randomised controlled trials. Acupuncture In Medicine 2002; 20:168–74.
Park J, White A, Lee H, Yamashita H, Ernst E. Credibility of a Newly Developed Sham Needle. Journal of Japan 2000; 3: 1: 111-14.
Park J, White A, Lee H, Ernst E. Development of a New Sham Needle . Acupuncture in Medicine 1999; 17:110-2.
Park J, White A, James M, Hemsley A, Johnson P, Chambers J, Ernst E. Acupuncture for Subacute Stroke Rehabilitation: A Sham-Controlled, Subject- and Assessor-Blind, Randomized Trial. Arch Intern Med 2005; 165: 2026 -31.
5. Videos & More Information
For more information or detailed research papers on Park Sham Device please contact:
Tel: +44 1392 829500
Fax: +44 1392 823232
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