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Clinical Trials/NCT03928860
NCT03928860CompletedNot Applicable

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

Kırıkkale University1 site in 1 country15 target enrollmentStarted: June 1, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
15
Locations
1
Primary Endpoint
Femoral Artery Diameter Doppler Ultrasonography

Study Overview

Brief Summary

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

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

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
35 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

OMT Session and Doppler Ultrasonography

Experimental

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

Intervention: OMT session (Other)

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Kırıkkale University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Muhammet Ayhan ORAL

Research Assistant

Kırıkkale University

Study Sites (1)

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