Alterations in Bioelectric Activity at Acupuncture Points Following CV4 Cranial Manipulation
NCT ID: NCT05190731
Last Updated: 2022-04-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
77 participants
INTERVENTIONAL
2017-11-10
2018-11-07
Brief Summary
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Detailed Description
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Ting (Jing-Well) points are acupuncture points located at the proximal edges of the finger- and toenails that represent the beginning and end of 14 acupuncture meridians as described in Traditional Chinese Medicine and Japanese systems. Measurement of electrical activity at Ting points is performed by a physicist who has extensive experience using a device known as the Apparatus for Meridian Identification (AMI). Data collected and analyzed by the AMI for both CV4 and Sham groups is compared statistically for significant differences in before vs. after electrical activity and specific acupuncture meridians affected. One particular analysis of After Polarization (AP) potentials correlates with changes in autonomic nervous system activity.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Contact touch at occipital region, but no actual cranial manipulation
Each subject was treated with Sham by CSPOMM and NMM board-certified osteopathic physicians. The physician's finger pads of both hands were placed underneath the supine subject's head in contact on the occipital squama medial to the lambdoidal and occipitomastoid sutures. The subject's head rested passively on the finger pads for 3 minutes. No cranial manipulative forces were applied.
Sham
Touch only, no osteopathic cranial manipulation
Osteopathic cranial manipulative medicine
Each subject was treated with CV4 technique by CSPOMM and NMM board-certified osteopathic physicians. All CV4 treatments were performed by one individual according to standardized protocol. The physician's hands were placed underneath the occiput with the thenar eminences in contact on the occipital squama medial to the lambdoidal and occipitomastoid sutures. Inherent cranial rhythmic motion was identified and thenar eminences followed occipital motion anteriorly during the extension phase until a still point was attained. This position was held until the still point released (usually about 3 minutes) and normal cranial motion ensued.
Osteopathic cranial manipulative medicine
Osteopathic cranial manipulative medicine technique using compression of 4th ventricle technique
Interventions
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Osteopathic cranial manipulative medicine
Osteopathic cranial manipulative medicine technique using compression of 4th ventricle technique
Sham
Touch only, no osteopathic cranial manipulation
Eligibility Criteria
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Inclusion Criteria
* Recruited by local flyers and word of mouth marketing
* Able to lay supine for about 30 minutes
Exclusion Criteria
* Identifiable acute illness of any kind
* Past medical history of stroke or transient ischemic attack within past 6 months
* Past medical history of intracranial hemorrhage, increased intracranial pressure, or seizure disorder
* Pregnant females
18 Years
78 Years
ALL
Yes
Sponsors
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Jan T Hendryx
OTHER
Responsible Party
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Jan T Hendryx
Clinical Professor of OPP and Family Medicine
Principal Investigators
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Jan Hendryx, DO
Role: PRINCIPAL_INVESTIGATOR
Lake Erie College of Osteopathic Medicine
Locations
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LECOM Health
Erie, Pennsylvania, United States
Countries
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References
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Jakel A, von Hauenschild P. Therapeutic effects of cranial osteopathic manipulative medicine: a systematic review. J Am Osteopath Assoc. 2011 Dec;111(12):685-93.
Zurowska A, Malak R, Kolcz-Trzesicka A, Samborski W, Paprocka-Borowicz M. Compression of the Fourth Ventricle Using a Craniosacral Osteopathic Technique: A Systematic Review of the Clinical Evidence. Evid Based Complement Alternat Med. 2017;2017:2974962. doi: 10.1155/2017/2974962. Epub 2017 Oct 18.
Curi ACC, Maior Alves AS, Silva JG. Cardiac autonomic response after cranial technique of the fourth ventricle (cv4) compression in systemic hypertensive subjects. J Bodyw Mov Ther. 2018 Jul;22(3):666-672. doi: 10.1016/j.jbmt.2017.11.013. Epub 2017 Dec 9.
Abenavoli A, Badi F, Barbieri M, Bianchi M, Biglione G, Dealessi C, Grandini M, Lavazza C, Mapelli L, Milano V, Monti L, Seppia S, Tresoldi M, Maggiani A. Cranial osteopathic treatment and stress-related effects on autonomic nervous system measured by salivary markers: A pilot study. J Bodyw Mov Ther. 2020 Oct;24(4):215-221. doi: 10.1016/j.jbmt.2020.07.017. Epub 2020 Aug 4.
Arienti C, Farinola F, Ratti S, Dacco S, Fasulo L. Variations of HRV and skin conductance reveal the influence of CV4 and Rib Raising techniques on autonomic balance: A randomized controlled clinical trial. J Bodyw Mov Ther. 2020 Oct;24(4):395-401. doi: 10.1016/j.jbmt.2020.07.002. Epub 2020 Jul 31.
Rechberger V, Biberschick M, Porthun J. Effectiveness of an osteopathic treatment on the autonomic nervous system: a systematic review of the literature. Eur J Med Res. 2019 Oct 25;24(1):36. doi: 10.1186/s40001-019-0394-5.
Cutler MJ, Holland BS, Stupski BA, Gamber RG, Smith ML. Cranial manipulation can alter sleep latency and sympathetic nerve activity in humans: a pilot study. J Altern Complement Med. 2005 Feb;11(1):103-8. doi: 10.1089/acm.2005.11.103.
Miana L, Bastos VH, Machado S, Arias-Carrion O, Nardi AE, Almeida L, Ribeiro P, Machado D, King H, Silva JG. Changes in alpha band activity associated with application of the compression of fourth ventricular (CV-4) osteopathic procedure: a qEEG pilot study. J Bodyw Mov Ther. 2013 Jul;17(3):291-6. doi: 10.1016/j.jbmt.2012.10.002. Epub 2012 Nov 16.
Li QQ, Shi GX, Xu Q, Wang J, Liu CZ, Wang LP. Acupuncture effect and central autonomic regulation. Evid Based Complement Alternat Med. 2013;2013:267959. doi: 10.1155/2013/267959. Epub 2013 May 26.
Ahn AC, Colbert AP, Anderson BJ, Martinsen OG, Hammerschlag R, Cina S, Wayne PM, Langevin HM. Electrical properties of acupuncture points and meridians: a systematic review. Bioelectromagnetics. 2008 May;29(4):245-56. doi: 10.1002/bem.20403.
Muehsam D, Chevalier G, Barsotti T, Gurfein BT. An Overview of Biofield Devices. Glob Adv Health Med. 2015 Nov;4(Suppl):42-51. doi: 10.7453/gahmj.2015.022.suppl. Epub 2015 Nov 1.
Comunetti A, Laage S, Schiessl N, Kistler A. Characterisation of human skin conductance at acupuncture points. Experientia. 1995 Apr 15;51(4):328-31. doi: 10.1007/BF01928888.
Ahn AC, Wu J, Badger GJ, Hammerschlag R, Langevin HM. Electrical impedance along connective tissue planes associated with acupuncture meridians. BMC Complement Altern Med. 2005 May 9;5:10. doi: 10.1186/1472-6882-5-10.
Kramer S, Winterhalter K, Schober G, Becker U, Wiegele B, Kutz DF, Kolb FP, Zaps D, Lang PM, Irnich D. Characteristics of electrical skin resistance at acupuncture points in healthy humans. J Altern Complement Med. 2009 May;15(5):495-500. doi: 10.1089/acm.2008.0331.
Colbert AP, Hammerschlag R, Aickin M, McNames J. Reliability of the Prognos electrodermal device for measurements of electrical skin resistance at acupuncture points. J Altern Complement Med. 2004 Aug;10(4):610-6. doi: 10.1089/acm.2004.10.610.
Other Identifiers
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24-177
Identifier Type: -
Identifier Source: org_study_id
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