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

NCT ID: NCT04479384

Last Updated: 2020-07-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2020-05-01

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.

Conditions

High Blood Pressure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention group

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

Group Type: EXPERIMENTAL

Manual therapy - osteopathic techniques

Intervention Type: OTHER

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

Control group

Supine position 10 minutes on the bench.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

International Academy of Osteopathy

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mette Pedersen, BSc

Role: PRINCIPAL_INVESTIGATOR

International Academy of Osteopathy

Locations

Næstved Rygcenter

Næstved, , Denmark

Countries

Denmark

Other Identifiers

201910 EN PEDERSEN M PROTOCOL

Identifier Type: -

Identifier Source: org_study_id