Hypertension and Osteopathic Treatment (HOT)

October 12, 2023 updated by: Larkin Community Hospital

The Utilization of Osteopathic Manipulation (OMT) as an Adjunct Therapy in the Treatment of Hypertension

The goal of this study is to demonstrate the use of osteopathic manipulative therapy (OMT) in the effective management of hypertension. The investigators hypothesize that by addressing/correcting somatic dysfunctions with OMT, the sympathetic overdrive that could be the root cause of the elevation in blood pressure will be downregulated. If this is the case, then an effective therapy for hypertension could indeed be regular OMT treatment. This could also result in the avoidance of potentially harmful antihypertensive medications which comprise a majority of the current therapeutic strategy in the treatment of hypertension (along with lifestyle modification). A third implication of the results of this project could be a reduction in the progression of this disease. Under the current standard of care, a majority of hypertensive patients only experience a worsening of the disease over time under the current therapeutic guidelines.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Approximately 60% of American adult population has prehypertension or hypertension. Subgroups such as African Americans, elderly, low-socioeconomic-status, and the overweight population, are disproportionately affected. Larkin Community Hospital (LCH) and its affiliated sites provide a great number of patients in these particular subgroups and this represents an ideal institution to study this tremendous health issue. Hypertension is a progressive disease and it has been shown·that, later in life, patients with borderline hypertension will progress at a much higher rate to Stage 1 or 2 hypertension as compared with normotensive population. The Framingham study has been demonstrated after 26 years of follow up, that 71% of patients with high-normal blood pressure (systolic, 130-139 mm Hg; diastolic, 85-89) developed clinical hypertension later in life. The Tecumseh blood pressure study has shown that subjects aged between 20 and 40 years old with borderline hypertension (average BP 130.7/93.8) have had significantly higher childhood (average age 6 years) BP levels compared with normotensive ones, further illustrating the propensity of this disease to progress. Also, the bell-shaped curve of blood pressure in the general population shows that the largest group of people will have blood pressures in the prehypertensive range, showing what a large proportion of the population would be affected by advances in the management of this disease.

Osteopathic manipulative therapy (OMT) is a therapeutic modality utilized by osteopathic physicians to address somatic dysfunctions in the musculoskeletal system. Somatic dysfunctions are abnormalities in musculoskeletal tissue texture and intervertebral joint dysfunction. Close associations between spinal vertebrae and the autonomic nervous system via the sympathetic trunk and ganglia are believed to be one of the mechanisms by which musculoskeletal system changes can affect other organs (somatovisceral reflex). Indeed, osteopathic philosophy posits that OMT has a distinct effect beyond the musculoskeletal system. Additionally, the autonomic and lymphatic systems and their effects upon the function of the cardiovascular system have been extensively studied. OMT has been shown by Stiles to significantly decrease both mortality and morbidity of patients with cardiovascular dysfunctions. Rogers et al. have also reported that OMT has been demonstrated to be of significant value in some patients with coronary insufficiency.

The bulk of the sympathetic nervous system lies adjacent to the thoracic spine as well as the superior lumbar spine. Particularly, the sympathetic innervation of the heart has its origins in cord segments T1-T6, with synapses occurring between pre-and post-ganglionic fibers in the upper thoracic and/or cervical ganglia. As previously discussed, alterations in the spinal mechanics and the presence of somatic dysfunctions in these regions of the spine have been theorized to alter the function of the autonomic nervous system originating from these regions. Specific cardiovascular effects of these dysfunctions are increased heart rate, increased contractility, increased cardiac work-load, and increased total peripheral resistance. To provide further evidence of the link between the musculoskeletal system and the cardiovascular system, it was demonstrated that patients with Travell triggerpoints in the right pectoralis muscle may be prone to periods of supraventricular tachyarrhythmias. When these trigger points are the etiologies of the arrhythmias, the arrhythmia disappears when the trigger point is effectively treated.

The goal of this study is to demonstrate the use of OMT in the effective management of hypertension. The investigators hypothesize that by addressing/correcting somatic dysfunctions with OMT, it will downregulate the sympathetic overdrive that could be the root cause of the elevation in blood pressure. If this is the case, then an effective therapy for hypertension could indeed be regular OMT treatment. This could also result in the avoidance of potentially harmful antihypertensive medications which comprise a majority of the current therapeutic strategy in the treatment of hypertension (along with lifestyle modification). A third implication of the results of this project could be a reduction in the progression of this disease. As discussed above, a majority of hypertensive patients only experience a worsening of the disease over time under the current therapeutic guidelines.

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Blood pressure meeting the criteria for pre-hypertension (130-139/85-89) or stage 1 hypertension (140-159/90-99) at two different instances
  • Otherwise healthy adult patients consenting to study participation

Exclusion Criteria:

  • Presence of co-morbid renal or liver disease
  • medication regimen of more than one anti-hypertensive medication
  • Presence of pre-existing heart disease, CAD (coronary artery disease), severe stenotic valvular disease, CHF (congestive heart failure), cardiomyopathy
  • Presence of condition that would make application of OMT protocol impossible
  • Pregnancy
  • Patient refusal

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: OMT Group
During the initial visit, the subject will have his BP recorded manually by the osteopathic physician in a standardized fashion. The subject will then undergo the OMT protocol and have his BP recorded again immediately afterwards. This will represent the conclusion of the initial visit. There will be 2 subsequent visits about 2-3 weeks apart that will be identical to this visit. Following the third visit, the next follow-up will be 2 months afterwards. However, the patient will only have his BP checked, and will not undergo an OMT treatment. The final visit will be another 2 months afterwards and will also be a simple BP check with no OMT treatment. The principles of lifestyle modification (diet/exercise/weight loss) will also be discussed at each visit.
Procedure: Osteopathic Manipulative Therapy

All OMT techniques will be performed by osteopathic physicians who will have received training specific to this protocol prior to study initiation. All used techniques will be slow moving and gentle to augment rest and relaxation, promote autonomic balance, and release fascial contractures. The techniques that will be used in this protocol are:

  1. OM Occipitomastoid release technique
  2. Sub-Occipital Release Technique
  3. Rib Raising Technique
  4. Rotatory stimulation of posterior Chapman's Reflexes
  5. Lymphatic Pumps and Effleurage: (Pedal Pump of Dalrymple)
Other Names:
  • OMT
  • Osteopathic Manipulation Treatment
  • OMM
  • NMM
  • Osteopathic Manipulation Medicine
  • Neuromusculoskeletal Medicine
  • Neuromuscular Medicine
Behavioral: Lifestyle Modification
Patients will be counseled on healthy behaviors such as regular exercise, weight loss, and a healthy diet
Placebo Comparator: Control Group
Patients in this arm will only receive lifestyle modification recommendations at each visit, along with a BP check. No antihypertensive medication changes will be made unless indicated by the guidelines.
Behavioral: Lifestyle Modification
Patients will be counseled on healthy behaviors such as regular exercise, weight loss, and a healthy diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood Pressure
Time Frame: 14 weeks
Participants will have an initial BP measurement, followed by measurements at 2, 4 and 6 weeks (both before and after OMT treatment performed at those visits). Then, they will have a simple BP check at 10 weeks and finally at 14 weeks. The goal of these measurements is to ascertain whether or not there is a change of baseline systolic/diastolic BP with serial OMT treatments
14 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Larkin Community Hospital

Collaborators

Miami Beach Community Health Center

Investigators

  • Principal Investigator: Rohit S Mehra, DO, MPH, MS, Larkin Community Hospital
  • Study Director: David Stuckey, DO, Larkin Community Hospital
  • Study Chair: Scott E Spagnolo-Hye, DO, MS, Larkin Community Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2015

Primary Completion (Actual)

March 30, 2016

Study Completion (Actual)

March 30, 2016

Study Registration Dates

First Submitted

November 7, 2015

First Submitted That Met QC Criteria

November 11, 2015

First Posted (Estimated)

November 16, 2015

Study Record Updates

Last Update Posted (Actual)

October 16, 2023

Last Update Submitted That Met QC Criteria

October 12, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LCH-2-022015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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