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The purpose this study is to determine which manual medicine technique or combination of techniques has the greatest effect on the natural changes in heart rate.
This study intends to examine how three different OMM techniques, sub-occipital release, rib-raising, and stellate ganglion release, impact autonomic nervous system tone. Subjects will be randomly assigned to one of four cohort groups, receiving either sub-occipital release, rib-raising, stellate ganglion release or all three treatment techniques. A shift towards sympathetic tone will be induced in all subjects using a tilted-to-seated-position test (Tilt-Seated Position test) and cognitive challenge test, consisting of computerized questions that become progressively more difficult, and which subjects are asked to answer as quickly and accurately as possible. These stress tests will be induced twice, once without any OMM treatment and a second time with the designated OMM treatment(s). The sympathetic-dependent response to orthostatic change and cognitive challenges will be determined by Fourier analysis of heart rate variability, recorded using an EKG attached to each subject.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sub-Occipital Release | Active Comparator | Osteopathic Manual Medicine |
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| Rib-Raising | Active Comparator | Osteopathic Manual Medicine |
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| Stellate Ganglion Release | Active Comparator | Osteopathic Manual Medicine |
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| All techniques | Active Comparator | Osteopathic Manual Medicine |
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| All Techniques-S | Sham Comparator | Sham Osteopathic Manual Medicine |
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| Sub-Occipital Release-S | Sham Comparator | Sham Osteopathic Manual Medicine |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Osteopathic Manual Medicine | Other | Osteopathic Manual Medicine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Heart Rate Variability | The participant will lay on a table with electrocardiogram leads recording heart rate while an investigator manually engages the soft tissue on different areas of the participant's head, neck, or back. | one hour |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of Diet and sleep on Heart Rate Variability | heart rate | Three days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jayme D Mancini, PhD, DO | New York Institute of Technology, College of Osteopathic Medicine | Principal Investigator |
| Theodore Flaum, DO | New York Institute of Technology, College of Osteopathic Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York Institute of Technology College of Osteopathic Medicine Academic Health Care Center | Old Westbury | New York | 11568 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20606239 | Background | Henderson AT, Fisher JF, Blair J, Shea C, Li TS, Bridges KG. Effects of rib raising on the autonomic nervous system: a pilot study using noninvasive biomarkers. J Am Osteopath Assoc. 2010 Jun;110(6):324-30. | |
| 22182951 | Background | Shi X, Rehrer S, Prajapati P, Stoll ST, Gamber RG, Downey HF. Effect of cranial osteopathic manipulative medicine on cerebral tissue oxygenation. J Am Osteopath Assoc. 2011 Dec;111(12):660-6. |
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| ID | Term |
|---|---|
| C005703 | salicylhydroxamic acid |
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| Rib-Raising-S | Sham Comparator | Sham Osteopathic Manual Medicine |
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| Stellate Ganglion Release -S | Sham Comparator | Sham Osteopathic Manual Medicine |
|
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| Sham | Other | Osteopathic Manual Medicine |
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