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

Not Applicable

Completed

• Conditions: High Blood Pressure
• Interventions: Other: Manual therapy - osteopathic techniques

• Registration Number: NCT04479384
• Lead Sponsor: International Academy of Osteopathy

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.

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 Timeline

• Study Start: 2019-09-01
• Primary Completion: 2020-01-30
• Study Completion: 2020-05-01
• Status Verified: 2020-07
• Study First Submitted: 2020-07-16
• Study First Submitted QC: 2020-07-20
• Last Update Submitted: 2020-07-20
• Study First Posted: 2020-07-21
• Last Update Posted: 2020-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Manual therapy - osteopathic techniques	Thoracic manipulation T1-T5 if somatic dysfunction. Intrathoracic fascia stretch x 3. Recoil sternum x 3. Cranial base release - 4 steps.

Primary Outcome Measures

Name	Time	Method
Systolic and diastolic blood pressure post 1-minute	Post 1-minute	Systolic blood pressure and diastolic blood pressure
Systolic and diastolic blood pressure post 10-minute	Post 10-minute	Systolic blood pressure and diastolic blood pressure
Systolic and diastolic blood pressure baseline	Baseline	Systolic blood pressure and diastolic blood pressure
Systolic and diastolic blood pressure post 5-minute	Post 5-minute	Systolic blood pressure and diastolic blood pressure

Trial Locations

Locations (1)

Næstved Rygcenter; 🇩🇰 Næstved, Denmark