The Effects of Mid-thoracic Manipulation on Heart Rate Variability.
1 other identifier
interventional
90
1 country
1
Brief Summary
The topic of spinal manipulation (SM) has been a source of increasing research over the past decade. Research has focused primarily upon the functional and clinical outcomes associated with SM. The physiological mechanisms underlying the clinical changes experienced following SM are still largely unknown. Current thought suggests that SM may have an effect upon the neurophysiological system, specifically the autonomic nervous system. The purpose of this study will be to explore the effects of SM upon the autonomically regulated cardiovagal response.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2014
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
February 16, 2015
CompletedFirst Posted
Study publicly available on registry
March 5, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedMarch 5, 2015
February 1, 2015
1.9 years
February 16, 2015
February 28, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Heart Rate Variability (HRV)
Change in heart rate variability via continuous heart rate monitoring
5 minutes pre-intervention (baseline), immediately post intervention, 10 minutes post intervention
Study Arms (2)
Experimental Group
EXPERIMENTALWhile lying in supine, subjects will receive a single posterior to anterior directed spinal manipulation to the mid-thoracic region (T4-5).
Sham Group
SHAM COMPARATORSham group will procedures will be identical with the exception of the spinal manipulation intervention. Sham shall not receive the spinal manipulation intervention.
Interventions
Subject will be positioned in supine identical to the experimental group, but no spinal manipulation will be delivered.
Eligibility Criteria
You may qualify if:
- Healthy adults
You may not qualify if:
- History of back surgeries, osteopenia, osteoporosis, spinal fractures, rib fractures, chronic pain over three months, or heart conditions. Subjects will also be excluded if they are currently taking or have a significant history of taking steroid or anticoagulant medications.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mount St. Mary's College
Los Angeles, California, 90007, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Derrick Sueki, DPT
Mount St. Mary's College, Los Angeles, CA
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 16, 2015
First Posted
March 5, 2015
Study Start
January 1, 2014
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
March 5, 2015
Record last verified: 2015-02