The Effects of Mid-thoracic Manipulation on Heart Rate Variability.

Neurophysiological Mechanisms Underlying Spinal Manipulation Clinical Trial

Official title:

The Effects of Mid-thoracic Manipulation on Heart Rate Variability.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02379871
• Other study ID #: MountSMCLA 2
• Status: Enrolling by invitation
• Phase: N/A
• First received: February 16, 2015
• Last updated: February 28, 2015
• Start date: January 2014
• Est. completion date: December 2015

Study information

• Verified date: February 2015
• Source: Mount St. Mary's College, Los Angeles, CA
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

Subjects will be asked to report to the exercise room at Mount St. Mary's College in the physical therapy building for only one session lasting approximately 15-20 minutes. The subject will fill out a small questionnaire to rule out any health conditions, which would exclude them. The subject will next be informed about the methods and nature of the study after which they will be asked to sign an informed consent form. Once signed, the subject will be included into the study and will be randomized to either the manipulative group, the sham manipulation group or the control group. The Biocomm HRV Live! heart rate variability monitor will be attached to the subject's wrist who will then be asked to lie supine on a treatment table for five minutes. The monitor is composed of a simple recording electrode that is secured to the wrist with either tape or a band. At this time the principal investigator will perform a manual technique on the individuals randomized into the manipulation group. The subject will be asked to place his/her hands behind her neck with her elbows aligned with their body. The principal investigator will then slightly roll the subject's torso towards herself while placing her left hand in a flexed position underneath the subject's spine at the T4-T5 level. The principal investigator will then flex the subject's thoracic spine by placing her right forearm on the subject's elbows and asking the subject to do a slight crunch. Then the principal investigator will apply the high velocity-low amplitude thrust in the anterior-posterior direction through the subject's forearms and over her left hand under the subject. For the sham manipulation group, no force will be placed through the elbows, but all other aspects of positioning will be the same as the manipulation group. The control group will be asked to link their fingers behind their neck and rest for one minute. Following the intervention, the subject will be asked to lie quietly in supine for an additional ten minutes to record post manipulation responses.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 90
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy adults

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Neurophysiological Mechanisms Underlying Spinal Manipulation

Intervention

Other:
• Experimental Group
Supine mid-thoracic spinal manipulation to the T4/5 region
• Sham Group
Subject will be positioned in supine identical to the experimental group, but no spinal manipulation will be delivered.

Locations

Country	Name	City	State
United States	Mount St. Mary's College	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Mount St. Mary's College, Los Angeles, CA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No