Clinical trial NCT05190731: Alterations in Bioelectric Activity at Acupuncture Points Following CV4 Cranial Manipulation
Official title: Alterations in Bioelectric Activity at Acupuncture Jing-Well (Ting) Points Following CV4 Cranial Manipulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autonomic Imbalance
Lead sponsor: Lake Erie College of Osteopathic Medicine
Sponsor class: OTHER
First posted: 2022-01-13
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants randomized to sham group or osteopathic cranial manipulative medicine treatment group
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Autonomic Nervous System Activity at Acupuncture Ting Points
timeFrame: Within 15 minutes of sham or intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Erie
country: United States
facility: LECOM Health
state: Pennsylvania
Study officials:
affiliation: Lake Erie College of Osteopathic Medicine
name: Jan Hendryx, DO
role: PRINCIPAL_INVESTIGATOR
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