A Study of the Effects of Mid-Thoracic Spinal Manipulation and Spinal Mobilization on Heart Rate Variability

NCT02380599 | Unknown

• 1 other identifier: MountSMCLA 3
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Spinal mobilization and spinal manipulation are common techniques utilized in the field of physical therapy. Despite their common utility, little is known about the physiological mechanisms underlying the changes experienced following the interventions. Recent research suggests that neurological mechanisms may be involved in the post interventional changes, but research supporting this view is still evolving. Therefore, this study will explore whether there is a neurophysiological difference between spinal manipulation and spinal mobilization techniques. The neurophysiological difference will be measured by monitoring heart rate variability, a cardiovagal indicator of autonomic nervous system activity. The primary hypotheses of this study are three-fold, first that spinal manipulation will result in a change in heart rate variability that is different then sham intervention. Second, spinal mobilization will result in a change in heart rate variability that is different then sham intervention. Finally, the investigators hypothesize that spinal mobilization and spinal manipulation will produce different changes in heart rate variability.

Conditions

Physiology of Manipulation / Mobilization in Healthy Adults

Keywords

Spinal Manipulation; Mobilization; Autonomic Nervous System

Outcome Measures

Primary Outcomes (1)

• Change in Heart Rate Variability

  Change in heart rate variability monitored continuously

  5 minutes pre-intervention (baseline), immediately after each intervention

Study Arms (1)

Experimental Group

EXPERIMENTAL

Crossover assignment of mid-thoracic spinal manipulation, spinal mobilization, or sham ultrasound

Other: Spinal Manipulation; Other: Spinal Mobilization; Other: Sham Ultrasound

Interventions

Spinal Manipulation OTHER

Mid-thoracic spinal manipulation to T3-5 region

Experimental Group

Spinal Mobilization OTHER

Mid-thoracic spinal mobilization to T3-5 region

Experimental Group

Sham Ultrasound OTHER

Sham ultrasound to T3-5 region

Experimental Group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Mount St. Mary's College, Los Angeles, CA: lead

Study Sites (1)

Mount St. Mary's College

Los Angeles, California, 90007, United States

Location

MeSH Terms

Interventions

Manipulation, Spinal

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Physical Therapy Modalities; Therapeutics; Rehabilitation

Study Officials

• Derrick Sueki, DPT

  Mount St. Mary's College, Los Angeles, CA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 28, 2015
• First Posted: March 5, 2015
• Study Start: January 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2016
• Last Updated: April 15, 2015

Record last verified: 2015-04

Locations

US (1)