Hypertension and Osteopathic Treatment

NCT02605551 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-10-16

No results posted yet for this study

Summary

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.

Conditions

  • Prehypertension
  • Hypertension
  • Osteopathic Manipulation
  • Sympathetic Nervous System

Interventions

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)

BEHAVIORAL

Lifestyle Modification

Patients will be counseled on healthy behaviors such as regular exercise, weight loss, and a healthy diet

Sponsors & Collaborators

  • Miami Beach Community Health Center

    collaborator OTHER
  • Larkin Community Hospital

    lead OTHER

Principal Investigators

  • Rohit S Mehra, DO, MPH, MS · Larkin Community Hospital

  • David Stuckey, DO · Larkin Community Hospital

  • Scott E Spagnolo-Hye, DO, MS · Larkin Community Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-04-01
Primary Completion
2016-03-30
Completion
2016-03-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02605551 on ClinicalTrials.gov