Piezoelectric Sensor Analysis and Oscillating Force Delivered Vertebral Adjustment in the Evaluation and Treatment of the Spinal Column
DESCRIPTION
Piezoelectric sensor (i.e., piezoelectric accelerometer) technology is being utilized for the purpose of analyzing the mobility of each segment of the spinal column. Piezoelectric measuring systems have been historically used by industry in the measurement of force, pressure, acceleration, vibration, and/or strain (e.g., pressure changes in liquids and gases such as in shock tube studies, industrial machinery vibration monitoring for the purpose of diagnosing out-of-balance conditions/displacement of rotating parts). As used in the evaluation/assessment of the spinal column, piezoelectric sensor technology is intended for the purpose of determining if normal motion is occurring in the spine. The instrument is placed against a segment of the spinal column and a vibratory pulse is emitted by the device. The reading is recorded and graphically displayed on a computer screen and the waveform presented reportedly indicates the degree of rigidity (i.e., fixation, mechanical impedance) of each vertebra that is tested.
As a treatment for the spinal column, oscillating force is a form of instrument delivered vibratory adjustment used for the purpose of increasing the mobility of each treated spinal vertebra by reducing or eliminating fixation (i.e., mechanical impedance). It is possible that separate devices could be used in the application of the piezoelectric sensor technology and/or oscillating force; however, at present the primary device marketed for these purposes, the Pro-Adjuster® (i.e., S.M.A.R.T.-Adjuster®), utilizes the same tuning fork like hand-held instrument for the spinal piezoelectric sensor analysis and the oscillating force delivered adjustment. The device is used as both a diagnostic instrument and as a therapeutic instrument.
POLICY
The use of piezoelectric sensor technology in the evaluation of the spinal column is considered investigational.
The use of oscillating force in the treatment of the spinal column is considered investigational.
Any device utilized for this procedure must have FDA approval specific to the indication, otherwise it will be considered investigational.
ADDITIONAL INFORMATION
There is a lack of statistically significant data from published studies supporting the efficacy of piezoelectric sensor technology and oscillating force in the evaluation and treatment of the spinal column.
SOURCES
BlueCross BlueShield of Tennessee network physicians. January 2005.
Complete Guide to Medicare Coverage Issues [Computer software]. (2007, July). Coverage of Chiropractic Services (Section 240.1, p. 4-244). St. Anthony Publishing.
Keller, T. S., Colloca, C. J., Moore, R. J., Gunzburg, R., Harrison, D. E., & Harrison, D. D. (2006). Three-dimensional vertebral motions produced by mechanical force spinal manipulation. Journal of Manipulative and Physiological Therapeutics, 29 (6), 425-436. Abstract retrieved December 21, 2007 from PubMed database.
Pankoke, S., Hofmann, J., & Wolfel, H. P. (2001). Determination of vibration-related spinal loads by numerical simulation. Clinical Biochemistry, 16(Suppl. 1), S45-S56. Abstract retrieved December 21, 2007 from PubMed database.
Shear, R. (1999, February). Piezoelectric sensors for OEM applications. Retrieved January 26, 2005 from http://www.pro-adjuster.us.
U.S. Department of Health & Human Services. Centers for Medicare & Medicaid Services. LMRPs/LCDs for CIGNA Government Services. (2007, December). LCD for chiropractic service (manual manipulations) (L6104). Retrieved December 20, 2007 from http://www.cms.hhs.gov/mcd/viewlcd.asp?lcd_id=6104&lcd_version=15&show=all.
U.S. Food and Drug Administration. (2007, April). Center for Devices and Radiological Health. 501(k) Premarket Notification Database. K070866. Retrieved December 21, 2007 from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=24383.
U.S. Food and Drug Administration. (2005, June). Center for Devices and Radiological Health. 501(k) Premarket Notification Database. K070866. Retrieved December 21, 2007 from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=17612.
Volunteer TV 8: WVLT/DT Knoxville. Chiropractic: Expert Online. The Pro-Adjuster fine tunes the nervous system, painlessly! Retrieved January 26, 2005 from http://www.volunteertv.com/global/story.asp?s=2334399.
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EFFECTIVE DATE |
3/27/2008 |
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ID_BT
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