NCT05190731

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 10, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 24, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 7, 2018

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

December 29, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 13, 2022

Completed
Last Updated

April 22, 2022

Status Verified

April 1, 2022

Enrollment Period

8 months

First QC Date

December 29, 2021

Last Update Submit

April 14, 2022

Conditions

Autonomic Imbalance

Outcome Measures

Primary Outcomes (1)

  • Autonomic Nervous System Activity at Acupuncture Ting Points

    Bioelectric skin conductance at acupuncture points

    Within 15 minutes of sham or intervention

Study Arms (2)

Contact touch at occipital region, but no actual cranial manipulation

SHAM COMPARATOR

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.

Other: Sham

Osteopathic cranial manipulative medicine

ACTIVE COMPARATOR

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.

Other: Osteopathic cranial manipulative medicine

Interventions

Osteopathic cranial manipulative medicineOTHER

Osteopathic cranial manipulative medicine technique using compression of 4th ventricle technique

Osteopathic cranial manipulative medicine
ShamOTHER

Touch only, no osteopathic cranial manipulation

Contact touch at occipital region, but no actual cranial manipulation

Eligibility Criteria

Age18 Years - 78 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LECOM Health

Erie, Pennsylvania, 16509, United States

Location

Related Publications (15)

  • 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.

    PMID: 22182954BACKGROUND

  • 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.

    PMID: 29234380BACKGROUND

  • 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.

    PMID: 30100295BACKGROUND

  • 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.

    PMID: 33218514BACKGROUND

  • 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.

    PMID: 33218540BACKGROUND

  • 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.

    PMID: 31653268BACKGROUND

  • 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.

    PMID: 15750368BACKGROUND

  • 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.

    PMID: 23768271BACKGROUND

  • 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.

    PMID: 23762116BACKGROUND

  • 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.

    PMID: 18240287BACKGROUND

  • 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.

    PMID: 26665041BACKGROUND

  • 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.

    PMID: 7729497BACKGROUND

  • 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.

    PMID: 15882468BACKGROUND

  • 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.

    PMID: 19422323BACKGROUND

  • 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.

    PMID: 15353016BACKGROUND

MeSH Terms

Interventions

salicylhydroxamic acid

Study Officials

  • Jan Hendryx, DO

    Lake Erie College of Osteopathic Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Participants randomized to sham group or osteopathic cranial manipulative medicine treatment group
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Professor of OPP and Family Medicine

Study Record Dates

First Submitted

December 29, 2021

First Posted

January 13, 2022

Study Start

November 10, 2017

Primary Completion

June 24, 2018

Study Completion

November 7, 2018

Last Updated

April 22, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will share

Individual participant data underlying the results appearing in a scientific publication after de-identification including text, table, figures and appendices.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Data requests can be submitted beginning 9 months after article publication and data will remain accessible for up to 24 months thereafter. Extensions will be considered on a case-by-case basis.
Access Criteria
Please contact Director of Research, Lake Erie College of Osteopathic Medicine, 1858 West Grandview Blvd., Erie, PA, 16509

Locations

US(1)