Alterations in Bioelectric Activity at Acupuncture Points Following CV4 Cranial Manipulation

April 14, 2022 updated by: Jan T Hendryx

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

77

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Erie, Pennsylvania, United States, 16509
        • LECOM Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: 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.
Other: Sham
Touch only, no osteopathic cranial manipulation
Active Comparator: 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.
Other: Osteopathic cranial manipulative medicine
Osteopathic cranial manipulative medicine technique using compression of 4th ventricle technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Autonomic Nervous System Activity at Acupuncture Ting Points
Time Frame: Within 15 minutes of sham or intervention
Bioelectric skin conductance at acupuncture points
Within 15 minutes of sham or intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jan T Hendryx

Investigators

  • Principal Investigator: Jan Hendryx, DO, Lake Erie College of Osteopathic Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 10, 2017

Primary Completion (Actual)

June 24, 2018

Study Completion (Actual)

November 7, 2018

Study Registration Dates

First Submitted

December 29, 2021

First Submitted That Met QC Criteria

December 29, 2021

First Posted (Actual)

January 13, 2022

Study Record Updates

Last Update Posted (Actual)

April 22, 2022

Last Update Submitted That Met QC Criteria

April 14, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 24-177

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

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

IPD Sharing 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.

IPD Sharing Access Criteria

Please contact Director of Research, Lake Erie College of Osteopathic Medicine, 1858 West Grandview Blvd., Erie, PA, 16509

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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