Clinical trial NCT03928860: 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
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease
Keywords: Peripheral arterial disease
Osteopathic manual treatment
Lead sponsor: Kırıkkale University
Sponsor class: OTHER
First posted: 2019-04-26
Enrollment: 15
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Femoral Artery Diameter Doppler Ultrasonography
timeFrame: 10 minutes
measure: Femoral Artery Flow Doppler Ultrasonography
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Kırıkkale
country: Turkey
facility: Kırıkkale University
Study officials:
affiliation: Kırıkkale University
name: Muhammet Ayhan ORAL
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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.
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.