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

High Blood Pressure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04479384
• Other study ID #: 201910 EN PEDERSEN M PROTOCOL
• Status: Completed
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: May 1, 2020

Study information

• Verified date: July 2020
• Source: International Academy of Osteopathy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 1, 2020
• Est. primary completion date: January 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• High Blood Pressure
• Hypertension

Intervention

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

Locations

Country	Name	City	State
Denmark	Næstved Rygcenter	Næstved

Sponsors (1)

Lead Sponsor	Collaborator
International Academy of Osteopathy

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systolic and diastolic blood pressure baseline	Systolic blood pressure and diastolic blood pressure	Baseline
Primary	Systolic and diastolic blood pressure post 1-minute	Systolic blood pressure and diastolic blood pressure	Post 1-minute
Primary	Systolic and diastolic blood pressure post 5-minute	Systolic blood pressure and diastolic blood pressure	Post 5-minute
Primary	Systolic and diastolic blood pressure post 10-minute	Systolic blood pressure and diastolic blood pressure	Post 10-minute