Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT02380599 |
| Other study ID # |
MountSMCLA 3 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
N/A
|
| First received |
February 28, 2015 |
| Last updated |
April 14, 2015 |
| Start date |
January 2015 |
| Est. completion date |
December 2016 |
Study information
| Verified date |
April 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
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.
Description:
This study will utilize a crossover design to study autonomic nervous system responses in
healthy subjects. Prior to commencing data collection, Institutional Review Board approval
has been obtained from the Mount St. Mary's College Committee for the Protection of Human
Subjects. Once obtained subjects will be recruited from faculty, students, and staff of the
College. A snowball methodology will be used to recruit friends, family, and acquaintances
of these initial connections. To be included in this study, candidates must be between the
age of 18 and 55 years of age. They must not have pain in any area of their body that is
chronic in nature (has been present for greater then three months). Subjects who are
pregnant or have a history of spinal surgery will be excluded from participation in this
study. All subjects who fulfill the inclusion and exclusion criteria will be informed of the
intent, methods and risks associated with the study and given an opportunity to ask
questions. Following this information session, and if agreeing to participate in the study,
subjects will be asked to fill out the attached informed consent form. All subjects will be
notified and given the opportunity to withdrawal from the study at any time without
repercussions.
Once accepted into the study, subjects will fill out a personal history questionnaire to
gather demographic information such as age, medical history, gender, and current pain
levels. The subject will also be asked to fill out the General Anxiety Disorder 7-Item Scale
Questionnaire. Once collected, subjects will be assigned a confidential subject number and
all personal identifiers will be removed from subject information. All data will be scanned
and stored in a personal computer that is password protect. Also at this time, subjects will
be randomly assigned to a treatment group. Since this is a crossover design, all subjects
will receive all interventions, but the order of these interventions will be predetermined
and randomized.
At this point, subjects will be taken to a quiet room located within the Department of
Physical Therapy. This room is used as a lab and data collection room and has a physical
therapy treatment table. The subject will be asked to lie prone on the table and an
electrocardiographic recording sensory will be placed upon each wrist (two total). This
sensory will feed data regarding heart rate to a laptop computer that will be collected
using the Biocomm HRV Live! Heart Rate Variability (HRV) Data Acquisition program. Once the
strength and stability of the signal is verified, the subject will be instructed to rest
quietly for five minutes in order to gather baseline heart rate data. Following this
five-minute timeframe, the subject will receive one of three interventions based upon the
previously mentioned randomization process. The three interventions utilized in the study
will be a posterior to anterior spinal manipulation delivered to T4-5 spinal segment,
posterior to anterior spinal mobilization applied to the T4-5 spinal segment for 30 seconds,
or sham therapeutic ultrasound applied to the T4-5 spinal region bilaterally for 30 seconds
(the ultrasound machines will not be turned on). Between each of these interventions,
subjects will be instructed to rest quietly for five minutes in order to stabilize the
body's cardiovagal responses. Following completion of these three interventions, subjects
will allowed to ask additional questions and will be given the number of the principal
investigator and the IRB office to contact if they have questions or concerns in the future.
