Alterations in Bioelectric Activity at Acupuncture Points Following CV4 Cranial Manipulation

Autonomic Imbalance Clinical Trial

Official title:

Alterations in Bioelectric Activity at Acupuncture Jing-Well (Ting) Points Following CV4 Cranial Manipulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05190731
• Other study ID #: 24-177
• Status: Completed
• Phase: N/A
• Start date: November 10, 2017
• Est. completion date: November 7, 2018

Study information

• Verified date: April 2022
• Source: Lake Erie College of Osteopathic Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

By measuring specific electrical parameters at acupuncture points that have been shown to correlate with ANS activity, the objectives of this study were to: 1) determine if CV4 has any influence on the bioelectric properties of the acupuncture meridian system, and 2) determine if CV4 affects the ANS.

Description:

This study is designed to measure bioelectrical activity at acupuncture Ting (Jing-Well) points immediately before and after employing a specific Osteopathic Cranial Manipulative Medicine (OCMM) technique called CV4 (Compression of the 4th Ventricle) vs. a Sham treatment. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: November 7, 2018
• Est. primary completion date: June 24, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 78 Years

Eligibility

Inclusion Criteria:

• Males and females from the Erie, PA, area aged 18-78 years
• Recruited by local flyers and word of mouth marketing
• Able to lay supine for about 30 minutes

Exclusion Criteria:

• Persons under the age of 18 years and persons unable to attend the in-person research sessions in Erie, PA.
• 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

Related Conditions & MeSH terms

• Autonomic Imbalance

Intervention

Other:
• Osteopathic cranial manipulative medicine
Osteopathic cranial manipulative medicine technique using compression of 4th ventricle technique
• Sham
Touch only, no osteopathic cranial manipulation

Locations

Country	Name	City	State
United States	LECOM Health	Erie	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Jan T Hendryx

Country where clinical trial is conducted

United States, 

References & Publications (15)

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. — View Citation

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. Review. — View Citation

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. — View Citation

Arienti C, Farinola F, Ratti S, Daccò 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. — View Citation

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. — View Citation

Comunetti A, Laage S, Schiessl N, Kistler A. Characterisation of human skin conductance at acupuncture points. Experientia. 1995 Apr 15;51(4):328-31. — View Citation

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. — View Citation

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. — View Citation

Jäkel A, von Hauenschild P. Therapeutic effects of cranial osteopathic manipulative medicine: a systematic review. J Am Osteopath Assoc. 2011 Dec;111(12):685-93. Review. — View Citation

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. — View Citation

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. — View Citation

Miana L, Bastos VH, Machado S, Arias-Carrión 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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Autonomic Nervous System Activity at Acupuncture Ting Points	Bioelectric skin conductance at acupuncture points	Within 15 minutes of sham or intervention