NCT02193373

Brief Summary

The purpose this study is to determine which manual medicine technique or combination of techniques has the greatest effect on the natural changes in heart rate.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
126

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2014

Longer than P75 for not_applicable

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

June 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 15, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 17, 2014

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

July 5, 2019

Status Verified

July 1, 2019

Enrollment Period

3.9 years

First QC Date

July 15, 2014

Last Update Submit

July 1, 2019

Conditions

Osteopathic Manual Manipulation of Neurovascular Regulation

Keywords

Osteopathic Manipulative MedicineAutonomic Nervous SystemHeart Rate VariabilitySub-Occipital ReleaseRib-RaisingStellate Ganglion Release

Outcome Measures

Primary Outcomes (1)

  • Change in Heart Rate Variability

    The participant will lay on a table with electrocardiogram leads recording heart rate while an investigator manually engages the soft tissue on different areas of the participant's head, neck, or back.

    one hour

Secondary Outcomes (1)

  • Effect of Diet and sleep on Heart Rate Variability

    Three days

Study Arms (8)

Sub-Occipital Release

ACTIVE COMPARATOR

Osteopathic Manual Medicine

Other: Osteopathic Manual Medicine

Rib-Raising

ACTIVE COMPARATOR

Osteopathic Manual Medicine

Other: Osteopathic Manual Medicine

Stellate Ganglion Release

ACTIVE COMPARATOR

Osteopathic Manual Medicine

Other: Osteopathic Manual Medicine

All techniques

ACTIVE COMPARATOR

Osteopathic Manual Medicine

Other: Osteopathic Manual Medicine

All Techniques-S

SHAM COMPARATOR

Sham Osteopathic Manual Medicine

Other: Sham

Sub-Occipital Release-S

SHAM COMPARATOR

Sham Osteopathic Manual Medicine

Other: Sham

Rib-Raising-S

SHAM COMPARATOR

Sham Osteopathic Manual Medicine

Other: Sham

Stellate Ganglion Release -S

SHAM COMPARATOR

Sham Osteopathic Manual Medicine

Other: Sham

Interventions

Osteopathic Manual MedicineOTHER

Osteopathic Manual Medicine

Also known as: Sub-Occipital Release, Rib-Raising, Stellate Ganglion Release
All techniquesRib-RaisingStellate Ganglion ReleaseSub-Occipital Release
ShamOTHER

Osteopathic Manual Medicine

Also known as: Sham sub-occipital release, Sham stellate ganglion release, Sham rib raising
All Techniques-SRib-Raising-SStellate Ganglion Release -SSub-Occipital Release-S

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy Individual capable of giving consent between the ages of 20-50
  • Normal blood pressure as defined by the Seventh Report of US National Committee on Prevention, Detection, Education and Treatment of High Blood Pressure
  • Normal EKG
  • Normal Heart Rate

You may not qualify if:

  • Chronic Cardiovascular Disease (including but not limited to: congestive heart failure, previous myocardial infarction, any cardiomyopathy, any arrhythmia, or previous cardiac surgery)
  • Hypertension as defined by the Seventh Report of US National Committee on Prevention, Detection, Education and Treatment of High Blood Pressure or hypertensive medications
  • Smoking
  • Asthma
  • Pregnancy
  • Diabetes
  • Current or recent illness (within the past 7 days)
  • Any manipulative therapies within the previous 7 days (including but not limited to: osteopathic manipulative treatment, massage or acupuncture)
  • Well conditioned athletes (such as long distance runners)
  • Anyone who fails to have an increased heart rate with the passive tilt test (50 degrees head-up)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York Institute of Technology College of Osteopathic Medicine Academic Health Care Center

Old Westbury, New York, 11568, United States

Location

Related Publications (2)

  • Henderson AT, Fisher JF, Blair J, Shea C, Li TS, Bridges KG. Effects of rib raising on the autonomic nervous system: a pilot study using noninvasive biomarkers. J Am Osteopath Assoc. 2010 Jun;110(6):324-30.

    PMID: 20606239BACKGROUND

  • Shi X, Rehrer S, Prajapati P, Stoll ST, Gamber RG, Downey HF. Effect of cranial osteopathic manipulative medicine on cerebral tissue oxygenation. J Am Osteopath Assoc. 2011 Dec;111(12):660-6.

    PMID: 22182951BACKGROUND

MeSH Terms

Interventions

salicylhydroxamic acid

Study Officials

  • Jayme D Mancini, PhD, DO

    New York Institute of Technology, College of Osteopathic Medicine

    PRINCIPAL INVESTIGATOR

  • Theodore Flaum, DO

    New York Institute of Technology, College of Osteopathic Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2014

First Posted

July 17, 2014

Study Start

June 1, 2014

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

July 5, 2019

Record last verified: 2019-07

Locations

US(1)