Hypertension and Osteopathic Treatment

NCT02605551 | Withdrawn

• 1 other identifier: LCH-2-022015
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Prehypertension; Hypertension; Osteopathic Manipulation; Sympathetic Nervous System

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

OMT Group

ACTIVE COMPARATOR

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; Behavioral: Lifestyle Modification

Control Group

PLACEBO COMPARATOR

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

Interventions

Osteopathic Manipulative Therapy PROCEDURE

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)

Also known as: OMT, OMM, NMM, Osteopathic Manipulation Treatment, Osteopathic Manipulation Medicine, Neuromusculoskeletal Medicine, Neuromuscular Medicine

OMT Group

Lifestyle Modification BEHAVIORAL

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

Control Group; OMT Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Larkin Community Hospital: lead
• Miami Beach Community Health Center: collaborator

Related Publications (11)

• Daiber WF: Disorders of the Kidneys in Hoag JM (ed) Osteopathic Medicine. New York, McGraw-Hill, 1969, Ch 39, PP644-5

  BACKGROUND

• 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.

  PMID: 15505126 BACKGROUND

• 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.

  PMID: 4933751 BACKGROUND

• 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.

  PMID: 1986979 BACKGROUND

• 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.

  PMID: 2362331 BACKGROUND

• 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.

  PMID: 12748199 BACKGROUND

• The Foundations of Osteopathic Medicine, 3rd edition. Lippincott, Williams, and Wilkins. 2010. ISBN 0781766710

  BACKGROUND

• Fitzgerald M, Stiles, E: Osteopathic Hospitals' solution to DRGs may be OMT. The DO Nov. 1984: 97-101

  BACKGROUND

• 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.

  PMID: 1048963 BACKGROUND

• 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.

  PMID: 860697 BACKGROUND

• 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.

  PMID: 6885531 BACKGROUND

MeSH Terms

Conditions

Prehypertension; Hypertension

Interventions

Manipulation, Osteopathic

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Rohit S Mehra, DO, MPH, MS

  Larkin Community Hospital

  PRINCIPAL INVESTIGATOR

• David Stuckey, DO

  Larkin Community Hospital

  STUDY DIRECTOR

• Scott E Spagnolo-Hye, DO, MS

  Larkin Community Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2015
• First Posted: November 16, 2015
• Study Start: April 1, 2015
• Primary Completion: March 30, 2016
• Study Completion: March 30, 2016
• Last Updated: October 16, 2023

Record last verified: 2023-10