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出境医 / 临床实验 / The Effect of One Session Osteopathic Manuel Treatment on Femoral Artery Diameter and Flow

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

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.

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
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
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
Arms and Interventions
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.
Outcome Measures
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



Eligibility Criteria
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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
Contacts and Locations

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
Tracking Information
First Submitted Date  ICMJE April 22, 2019
First Posted Date  ICMJE April 26, 2019
Last Update Posted Date April 26, 2019
Actual Study Start Date  ICMJE June 1, 2017
Actual Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 23, 2019)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of One Session Osteopathic Manuel Treatment on Femoral Artery Diameter and Flow
Official Title  ICMJE The Effect of One Session Osteopathic Manuel Treatment on Femoral Artery Diameter and Flow in Patients With Peripheral Arterial Disease
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Peripheral Arterial Disease
Intervention  ICMJE 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.
Study Arms  ICMJE 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

Intervention: Other: OMT session
Publications *
  • 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.
  • Ramos-González E, Moreno-Lorenzo C, Matarán-Peñarrocha GA, Guisado-Barrilao R, Aguilar-Ferrándiz ME, Castro-Sánchez 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.
  • 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.
  • Thomaz SR, Teixeira FA, de Lima ACGB, Cipriano Júnior 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 23, 2019) 		15
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 1, 2019
Actual Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03928860
Other Study ID Numbers  ICMJE PAD AND ONE SESSION OMT
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Muhammet Ayhan ORAL, Kırıkkale University
Study Sponsor  ICMJE Kırıkkale University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Muhammet Ayhan ORAL Kırıkkale University
PRS Account Kırıkkale University
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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