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

Primary Purpose

Peripheral Arterial Disease

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
OMT session
Sponsored by
Kırıkkale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease focused on measuring Peripheral arterial disease, Osteopathic manual treatment

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kırıkkale University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

OMT Session and Doppler Ultrasonography

Arm Description

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

Outcomes

Primary Outcome Measures

Femoral Artery Diameter Doppler Ultrasonography
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
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 Outcome Measures

Full Information

First Posted
April 22, 2019
Last Updated
April 23, 2019
Sponsor
Kırıkkale University
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1. Study Identification

Unique Protocol Identification Number
NCT03928860
Brief Title
The Effect of One Session Osteopathic Manuel Treatment on Femoral Artery Diameter and Flow
Official Title
The Effect of One Session Osteopathic Manuel Treatment on Femoral Artery Diameter and Flow in Patients With Peripheral Arterial Disease
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
March 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kırıkkale University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease
Keywords
Peripheral arterial disease, Osteopathic manual treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OMT Session and Doppler Ultrasonography
Arm Type
Experimental
Arm Description
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 Type
Other
Intervention Name(s)
OMT session
Intervention Description
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 Measure Information:
Title
Femoral Artery Diameter Doppler Ultrasonography
Description
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.
Time Frame
10 minutes
Title
Femoral Artery Flow Doppler Ultrasonography
Description
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
Time Frame
10 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhammet Ayhan ORAL
Organizational Affiliation
Kırıkkale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kırıkkale University
City
Kırıkkale
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21147421
Citation
Cerritelli F, Carinci F, Pizzolorusso G, Turi P, Renzetti C, Pizzolorusso F, Orlando F, Cozzolino V, Barlafante G. Osteopathic manipulation as a complementary treatment for the prevention of cardiac complications: 12-Months follow-up of intima media and blood pressure on a cohort affected by hypertension. J Bodyw Mov Ther. 2011 Jan;15(1):68-74. doi: 10.1016/j.jbmt.2010.03.005. Epub 2010 May 8.
Results Reference
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PubMed Identifier
22863643
Citation
Ramos-Gonzalez E, Moreno-Lorenzo C, Mataran-Penarrocha GA, Guisado-Barrilao R, Aguilar-Ferrandiz ME, Castro-Sanchez AM. Comparative study on the effectiveness of myofascial release manual therapy and physical therapy for venous insufficiency in postmenopausal women. Complement Ther Med. 2012 Oct;20(5):291-8. doi: 10.1016/j.ctim.2012.03.005. Epub 2012 May 3.
Results Reference
background
PubMed Identifier
18824395
Citation
Lombardini R, Marchesi S, Collebrusco L, Vaudo G, Pasqualini L, Ciuffetti G, Brozzetti M, Lupattelli G, Mannarino E. The use of osteopathic manipulative treatment as adjuvant therapy in patients with peripheral arterial disease. Man Ther. 2009 Aug;14(4):439-43. doi: 10.1016/j.math.2008.08.002. Epub 2008 Sep 27.
Results Reference
background
PubMed Identifier
29861222
Citation
Thomaz SR, Teixeira FA, de Lima ACGB, Cipriano Junior G, Formiga MF, Cahalin LP. Osteopathic manual therapy in heart failure patients: A randomized clinical trial. J Bodyw Mov Ther. 2018 Apr;22(2):293-299. doi: 10.1016/j.jbmt.2017.07.011. Epub 2017 Jul 29.
Results Reference
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The Effect of One Session Osteopathic Manuel Treatment on Femoral Artery Diameter and Flow

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