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

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ClinicalTrials.gov Identifier: NCT03928860
Recruitment Status : Completed
First Posted : April 26, 2019
Last Update Posted : April 26, 2019
Sponsor:
Information provided by (Responsible Party):
Muhammet Ayhan ORAL, Kırıkkale University

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

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Other: OMT session Not Applicable

Detailed Description:
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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of One Session Osteopathic Manuel Treatment on Femoral Artery Diameter and Flow in Patients With Peripheral Arterial Disease
Actual Study Start Date : June 1, 2017
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : March 1, 2019

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Arm Intervention/treatment
Experimental: OMT Session and Doppler Ultrasonography

OMT Session 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.

Doppler Ultrasonography Femoral artery diameter and flow evaluated by radiologist.

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

Other: OMT session
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 Outcome Measures :
  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




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Ages Eligible for Study:   35 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03928860


Locations
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Turkey
Kırıkkale University
Kırıkkale, Turkey
Sponsors and Collaborators
Kırıkkale University
Investigators
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Principal Investigator: Muhammet Ayhan ORAL Kırıkkale University

Publications:
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Responsible Party: Muhammet Ayhan ORAL, Research Assistant, Kırıkkale University
ClinicalTrials.gov Identifier: NCT03928860     History of Changes
Other Study ID Numbers: PAD AND ONE SESSION OMT
First Posted: April 26, 2019    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Muhammet Ayhan ORAL, Kırıkkale University:
Peripheral arterial disease
Osteopathic manual treatment

Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases