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

NCT03928860 | Completed

• 1 other identifier: PAD AND ONE SESSION OMT
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Peripheral Arterial Disease

Keywords

Peripheral arterial disease; Osteopathic manual treatment

Outcome Measures

Primary Outcomes (2)

• 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.

  10 minutes

• 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

  10 minutes

Study Arms (1)

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

Other: OMT session

Interventions

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.

OMT Session and Doppler Ultrasonography

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kırıkkale University: lead

Study Sites (1)

Kırıkkale University

Kırıkkale, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 21147421 BACKGROUND

• 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.

  PMID: 22863643 BACKGROUND

• 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.

  PMID: 18824395 BACKGROUND

• 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.

  PMID: 29861222 BACKGROUND

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Muhammet Ayhan ORAL

  Kırıkkale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: April 22, 2019
• First Posted: April 26, 2019
• Study Start: June 1, 2017
• Primary Completion: December 31, 2018
• Study Completion: March 1, 2019
• Last Updated: April 26, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)