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Hypertension and Osteopathic Treatment (HOT)

Primary Purpose

Prehypertension, Hypertension, Osteopathic Manipulation

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Osteopathic Manipulative Therapy
Lifestyle Modification
Sponsored by
Larkin Community Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prehypertension

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    OMT Group

    Control Group

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Blood Pressure
    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

    Secondary Outcome Measures

    Full Information

    First Posted
    November 7, 2015
    Last Updated
    October 12, 2023
    Sponsor
    Larkin Community Hospital
    Collaborators
    Miami Beach Community Health Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02605551
    Brief Title
    Hypertension and Osteopathic Treatment
    Acronym
    HOT
    Official Title
    The Utilization of Osteopathic Manipulation (OMT) as an Adjunct Therapy in the Treatment of Hypertension
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Study Period Ended / Not Completed
    Study Start Date
    April 1, 2015 (Anticipated)
    Primary Completion Date
    March 30, 2016 (Actual)
    Study Completion Date
    March 30, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Larkin Community Hospital
    Collaborators
    Miami Beach Community Health Center

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Prehypertension, Hypertension, Osteopathic Manipulation, Sympathetic Nervous System

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    OMT Group
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Control Group
    Arm Type
    Placebo Comparator
    Arm Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Osteopathic Manipulative Therapy
    Other Intervention Name(s)
    OMT, OMM, NMM, Osteopathic Manipulation Treatment, Osteopathic Manipulation Medicine, Neuromusculoskeletal Medicine, Neuromuscular Medicine
    Intervention Description
    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: OM Occipitomastoid release technique Sub-Occipital Release Technique Rib Raising Technique Rotatory stimulation of posterior Chapman's Reflexes Lymphatic Pumps and Effleurage: (Pedal Pump of Dalrymple)
    Intervention Type
    Behavioral
    Intervention Name(s)
    Lifestyle Modification
    Intervention Description
    Patients will be counseled on healthy behaviors such as regular exercise, weight loss, and a healthy diet
    Primary Outcome Measure Information:
    Title
    Blood Pressure
    Description
    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
    Time Frame
    14 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Rohit S Mehra, DO, MPH, MS
    Organizational Affiliation
    Larkin Community Hospital
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    David Stuckey, DO
    Organizational Affiliation
    Larkin Community Hospital
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Scott E Spagnolo-Hye, DO, MS
    Organizational Affiliation
    Larkin Community Hospital
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    Citation
    Daiber WF: Disorders of the Kidneys in Hoag JM (ed) Osteopathic Medicine. New York, McGraw-Hill, 1969, Ch 39, PP644-5
    Results Reference
    background
    PubMed Identifier
    15505126
    Citation
    Wang Y, Wang QJ. The prevalence of prehypertension and hypertension among US adults according to the new joint national committee guidelines: new challenges of the old problem. Arch Intern Med. 2004 Oct 25;164(19):2126-34. doi: 10.1001/archinte.164.19.2126.
    Results Reference
    background
    PubMed Identifier
    4933751
    Citation
    Julius S, Schork MA. Borderline hypertension--a critical review. J Chronic Dis. 1971 Mar;23(10):723-54. doi: 10.1016/0021-9681(71)90005-1. No abstract available.
    Results Reference
    background
    PubMed Identifier
    1986979
    Citation
    Leitschuh M, Cupples LA, Kannel W, Gagnon D, Chobanian A. High-normal blood pressure progression to hypertension in the Framingham Heart Study. Hypertension. 1991 Jan;17(1):22-7. doi: 10.1161/01.hyp.17.1.22.
    Results Reference
    background
    PubMed Identifier
    2362331
    Citation
    Julius S, Jamerson K, Mejia A, Krause L, Schork N, Jones K. The association of borderline hypertension with target organ changes and higher coronary risk. Tecumseh Blood Pressure study. JAMA. 1990 Jul 18;264(3):354-8.
    Results Reference
    background
    PubMed Identifier
    12748199
    Citation
    Chobanian AV, Bakris GL, Black HR, Cushman WC, Green LA, Izzo JL Jr, Jones DW, Materson BJ, Oparil S, Wright JT Jr, Roccella EJ; National Heart, Lung, and Blood Institute Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure; National High Blood Pressure Education Program Coordinating Committee. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure: the JNC 7 report. JAMA. 2003 May 21;289(19):2560-72. doi: 10.1001/jama.289.19.2560. Epub 2003 May 14. Erratum In: JAMA. 2003 Jul 9;290(2):197.
    Results Reference
    background
    Citation
    The Foundations of Osteopathic Medicine, 3rd edition. Lippincott, Williams, and Wilkins. 2010. ISBN 0781766710
    Results Reference
    background
    Citation
    Fitzgerald M, Stiles, E: Osteopathic Hospitals' solution to DRGs may be OMT. The DO Nov. 1984: 97-101
    Results Reference
    background
    PubMed Identifier
    1048963
    Citation
    Rogers JT, Rogers JC. The role of osteopathic manipulative therapy in the treatment of coronary heart disease. J Am Osteopath Assoc. 1976 Sep;76(1):21-31. No abstract available.
    Results Reference
    background
    PubMed Identifier
    860697
    Citation
    Lown B, Verrier RL, Rabinowitz SH. Neural and psychologic mechanisms and the problem of sudden cardiac death. Am J Cardiol. 1977 May 26;39(6):890-902. doi: 10.1016/s0002-9149(77)80044-1.
    Results Reference
    background
    PubMed Identifier
    6885531
    Citation
    Cox JM, Gorbis S, Dick LM, Rogers JC, Rogers FJ. Palpable musculoskeletal findings in coronary artery disease: results of a double-blind study. J Am Osteopath Assoc. 1983 Jul;82(11):832-6. No abstract available.
    Results Reference
    background

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    Hypertension and Osteopathic Treatment

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