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Completed

NCT Number: NCT03928860

The Effect of One Session Osteopathic Manuel Treatment on Femoral Artery Diameter and Flow

The aim of this study was to investigate the effect of one session OMT on arterial circulation in patients with PAD.

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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Vascular Diseases Vascular Diseases

Age range

35 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kırıkkale University

Kirikkale, Turkey (Türkiye)

About this study

15 patients with PAD were included in the study. The OMT circulation model was applied to the participants for one session. Before and after the application, femoral artery diameter and flow rate in the patients were evaluated by doppler ultrasound

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with at least 3 months of clinical onset of peripheral vascular disease
  • Patients with ABI between 0.4-1.4
  • Patients up to Stage 2b according to the Fontaine classification system

Exclusion criteria

  • Patients undergoing vascular or endovascular surgery in the last 3 months
  • Patients with unstable angina
  • Patients with myocardial infarction (MI)
  • Patients with stroke
  • Patients with heart failure
  • Patients with significant liver or renal failure (ie, dialysis)
  • Acute infectious diseases
  • Patients with neoplasia

Treatment and study plan

OMT session

Other

Patients with PAD will be received 30 minutes of osteopathic manual treatment for one session. During application, the patient was in the supine position. OMT treatment session include, sub occipital release technique, supraclavicular release technique, sternal mobilization, omentum minus release, liver pumping, diaphragmatic mobilization, grand manevra technique, hip mobilization, knee mobilization and ankle mobilization. Each technique was applied for 3 minutes to patients.

Primary outcomes

  1. Femoral Artery Diameter Doppler Ultrasonography

    Time frame: 10 minutes

    Femoral artery diameter evaluated by radiologist. The femoral artery diameter unit is in mm (millimeters).

    In the evaluation, the wall contour characteristics of the vessel to be examined were evaluated and the diameter was measured. Color doppler examination was performed to determine whether the vessel contained color filling, patency, flow direction and turbulence.

    Peak systolic and end diastolic flow rates and flow pattern and flow rate were measured by spectral examination.

  2. Femoral Artery Flow Doppler Ultrasonography

    Time frame: 10 minutes

    Femoral artery flow evaluated by radiologist. The femoral artery flow unit is in ml/sn (milliliter/second).

    In the evaluation, the wall contour characteristics of the vessel to be examined were evaluated and the diameter was measured. Color doppler examination was performed to determine whether the vessel contained color filling, patency, flow direction and turbulence.

    Peak systolic and end diastolic flow rates and flow pattern and flow rate were measured by spectral examination

Sponsors and collaborators

Lead sponsor

Kırıkkale University

Other

Registry information

Official study title

The Effect of One Session Osteopathic Manuel Treatment on Femoral Artery Diameter and Flow in Patients With Peripheral Arterial Disease

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Apr 26, 2019
Registry last updated
Apr 26, 2019

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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