The Immediate Effect of an Osteopathic Manual Treatment on Blood Pressure in Adults With Hypertension - a Pilot Study.

NCT04479384 | Completed

• 1 other identifier: 201910 EN PEDERSEN M PROTOCOL
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to determine if 4 manual osteopathic treatment techniques; Spinal manipulation, stretch intrathoracic fascia, sternum recoil and cranial base release has an immediate effect on blood pressure (BP) in hypertensive adults.

Conditions

High Blood Pressure

Keywords

Hypertension; Manual techniques; Blood Pressure; Osteopathy; Treatment

Outcome Measures

Primary Outcomes (4)

• Systolic and diastolic blood pressure baseline

  Systolic blood pressure and diastolic blood pressure

  Baseline

• Systolic and diastolic blood pressure post 1-minute

  Systolic blood pressure and diastolic blood pressure

  Post 1-minute

• Systolic and diastolic blood pressure post 5-minute

  Systolic blood pressure and diastolic blood pressure

  Post 5-minute

• Systolic and diastolic blood pressure post 10-minute

  Systolic blood pressure and diastolic blood pressure

  Post 10-minute

Study Arms (2)

Intervention group

EXPERIMENTAL

Thoracic manipulation T1-T5 if somatic dysfunction. Intrathoracic fascia stretch x 3. Recoil sternum x 3. Cranial base release - 4 steps.

Other: Manual therapy - osteopathic techniques

Control group

NO INTERVENTION

Supine position 10 minutes on the bench.

Interventions

Manual therapy - osteopathic techniques OTHER

* HVLAT if any somatic dysfunction in T1-T5 * Stretch intrathoracic fascia x 3 * Recoil sternum x 3 * Cranial base release, 4 phases

Intervention group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adults 18-60 years old.
• Primary hypertension.
• Hypertension not more than grade 2, defined as: Systolic BP from 135-174 mmHg and diastolic BP from 85-104 mmHg.

You may not qualify if:

• Hypertension grade 3, defined as: Systolic BP from \>175 mmHg and diastolic BP \>105 mmHg, due to high risk of developing stroke, apoplexy and myocardial infarct.
• Positive hepato-jugular-reflux test, as a safety-test, to test pathological conditions of the heart.
• History of liver, kidney or known heart diseases, diagnosed by family physician as these conditions can contribute to secondary hypertension.
• Presence of contraindications for manual treatment, such as (but not limited to); infections, neurological symptoms, inflammation, haemophilia, ankylosis, prosthesis, pregnancy, cancer, osteoporosis, trauma and the use of blood-thinning medicines or corticosteroids.

Sponsors & Collaborators

• International Academy of Osteopathy: lead

Study Sites (1)

Næstved Rygcenter

Næstved, Denmark

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Mette Pedersen, BSc

  International Academy of Osteopathy

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 16, 2020
• First Posted: July 21, 2020
• Study Start: September 1, 2019
• Primary Completion: January 30, 2020
• Study Completion: May 1, 2020
• Last Updated: July 21, 2020

Record last verified: 2020-07

Locations

DK (1)