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

Peripheral Arterial Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03928860
• Other study ID #: PAD AND ONE SESSION OMT
• Status: Completed
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: March 1, 2019

Study information

• Verified date: April 2019
• Source: Kirikkale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: March 1, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

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.

Locations

Country	Name	City	State
Turkey	Kirikkale University	Kirikkale

Sponsors (1)

Lead Sponsor	Collaborator
Kirikkale University

Country where clinical trial is conducted

Turkey, 

References & 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. — View 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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