Neurophysiological Mechanisms Underlying Spinal ManipulationNCT02379871
The Effects of Mid-thoracic Manipulation on Heart Rate Variability.
A study testing Experimental Group in people with Neurophysiological Mechanisms Underlying Spinal Manipulation, run by Mount St. Mary's College, Los Angeles, CA at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Neurophysiological Mechanisms Underlying Spinal Manipulation
- What is being tested?
- Experimental Group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mount St. Mary's College
Los Angeles, California, 90007
About this study
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.
Read the detailed 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.
- Being tested
- Experimental Group, Sham Group
- Keywords
- Thoracic Spinal Manipulation, Autonomic Nervous System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental GroupOther
Supine mid-thoracic spinal manipulation to the T4/5 region
Sham GroupOther
Subject will be positioned in supine identical to the experimental group, but no spinal manipulation will be delivered.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | While lying in supine, subjects will receive a single posterior to anterior directed spinal manipulation to the mid-thoracic region (T4-5). Receives: Other: Experimental Group |
| Sham Group | Sham comparator | Sham group will procedures will be identical with the exception of the spinal manipulation intervention. Sham shall not receive the spinal manipulation intervention. Receives: Other: Sham Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Heart Rate Variability (HRV)
Change in heart rate variability via continuous heart rate monitoring
Measured: 5 minutes pre-intervention (baseline), immediately post intervention, 10 minutes post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2015 (estimated)
- Study startJan 2014
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurophysiological Mechanisms Underlying Spinal ManipulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mount St. Mary's College, Los Angeles, CA
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Derrick Sueki, Mount St. Mary's College, Los Angeles, CA
- Investigators
- Derrick Sueki, DPT, Principal investigator, Mount St. Mary's College, Los Angeles, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02379871
- Sponsor's protocol ID
- MountSMCLA 2
- Status last verified
- Feb 2015
- First submitted
- 16 Feb 2015
- Last updated
- 5 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Mid-thoracic Manipulation on Heart Rate Variability.
- ClinicalTrials.gov ID
- NCT02379871
- Acronym / sponsor ID
- MountSMCLA 2
- Keywords
- Thoracic Spinal Manipulation, Autonomic Nervous System
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Mount St. Mary's College, Los Angeles, CAUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 5 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Experimental GroupWhile lying in supine, subjects will receive a single posterior to anterior directed spinal manipulation to the mid-thoracic region (T4-5). |
| Sham Group | Sham comparator | Other: Sham GroupSham group will procedures will be identical with the exception of the spinal manipulation intervention. Sham shall not receive the spinal manipulation intervention. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy adults
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental GroupSupine mid-thoracic spinal manipulation to the T4/5 region | Other | Experimental Group |
| Sham GroupSubject will be positioned in supine identical to the experimental group, but no spinal manipulation will be delivered. | Other | Sham Group |
Primary outcome
Change in Heart Rate Variability (HRV)
Time frame: 5 minutes pre-intervention (baseline), immediately post intervention, 10 minutes post intervention
Change in heart rate variability via continuous heart rate monitoring
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Derrick Sueki, DPT principal investigator
Mount St. Mary's College, Los Angeles, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Group in people with Neurophysiological Mechanisms Underlying Spinal Manipulation, run by Mount St. Mary's College, Los Angeles, CA at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Heart Rate Variability (HRV) (time frame: 5 minutes pre-intervention (baseline), immediately post intervention, 10 minutes post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2015; AzTrials last refreshed its copy on 6 Nov 2026.