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Completed

NCT Number: NCT04479384

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.

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Key information

Conditions

High Blood Pressure Cardiovascular Diseases Hypertension Vascular Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Næstved Rygcenter

Næstved, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Systolic and diastolic blood pressure baseline

    Time frame: Baseline

    Systolic blood pressure and diastolic blood pressure

  2. Systolic and diastolic blood pressure post 1-minute

    Time frame: Post 1-minute

    Systolic blood pressure and diastolic blood pressure

  3. Systolic and diastolic blood pressure post 5-minute

    Time frame: Post 5-minute

    Systolic blood pressure and diastolic blood pressure

  4. Systolic and diastolic blood pressure post 10-minute

    Time frame: Post 10-minute

    Systolic blood pressure and diastolic blood pressure

Sponsors and collaborators

Lead sponsor

International Academy of Osteopathy

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 21, 2020
Registry last updated
Jul 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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