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

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

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.

Study Overview

• Status: Completed
• Conditions: High Blood Pressure
• Intervention / Treatment: Other: Manual therapy - osteopathic techniques

Detailed Description

30 hypertensive adults (age=50.76±8.66 years, height= 1.75±0.082 m, weight=89.5±19.08 kg), were randomly assigned into one of two equally sized groups; a non- intervention and an intervention group in which patients received 4 manual techniques. Outcome measures included systolic- and diastolic BP pre-treatment and post-treatment 1-,5-, and 10-minutes. Two-way mixed ANOVA was used for statistical analysis.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Næstved, Denmark
    • Næstved Rygcenter

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention group; 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; HVLAT if any somatic dysfunction in T1-T5; Stretch intrathoracic fascia x 3; Recoil sternum x 3; Cranial base release, 4 phases
NO_INTERVENTION: Control group; Supine position 10 minutes on the bench.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: International Academy of Osteopathy
• Investigators: Principal Investigator: Mette Pedersen, BSc, International Academy of Osteopathy

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2019
• Primary Completion (ACTUAL): January 30, 2020
• Study Completion (ACTUAL): May 1, 2020

Study Registration Dates

• First Submitted: July 16, 2020
• First Submitted That Met QC Criteria: July 20, 2020
• First Posted (ACTUAL): July 21, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 21, 2020
• Last Update Submitted That Met QC Criteria: July 20, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Treatment; Hypertension; Blood Pressure; Manual techniques; Osteopathy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 201910 EN PEDERSEN M PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No