Hypertension Clinical Trial
— HOTOfficial title:
The Utilization of Osteopathic Manipulation (OMT) as an Adjunct Therapy in the Treatment of Hypertension
Verified date | October 2023 |
Source | Larkin Community Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | March 30, 2016 |
Est. primary completion date | March 30, 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Larkin Community Hospital | Miami Beach Community Health Center |
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. — View 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. — View Citation
Daiber WF: Disorders of the Kidneys in Hoag JM (ed) Osteopathic Medicine. New York, McGraw-Hill, 1969, Ch 39, PP644-5
Fitzgerald M, Stiles, E: Osteopathic Hospitals' solution to DRGs may be OMT. The DO Nov. 1984: 97-101
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. — View 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. — View 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. — View 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. — View 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. — View Citation
The Foundations of Osteopathic Medicine, 3rd edition. Lippincott, Williams, and Wilkins. 2010. ISBN 0781766710
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. — View Citation
* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 14 weeks |
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