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The Effect Of Osteopathic Manual Therapy On Arterial Circulation In Patients With Peripheral Arterial Disease

Primary Purpose

Peripheral Arterial Disease, Osteopathy in Diseases Classified Elsewhere

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Osteopathic Manual Therapy
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 therapy, artery diameter, arterial flow

Eligibility Criteria

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

Inclusion Criteria: diagnosed with PAD, clinical onset of the disease for at least 3 months, ABI value between 0.4 and 1.4, Grade 2b according to Fontaine classification system, Exclusion Criteria: vascular or endovascular surgery in the last 3 months, unstable angina, myocardial infarction (MI), stroke, heart failure, significant hepatic or renal failure (dialysis-related etc.), acute infectious disease, neoplasia

Sites / Locations

  • Kirikkale University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Osteopathic Manual Therapy Group (OMTG)

Control Group (CG)

Arm Description

The total duration of all techniques applied is 30 minutes. The techniques used in the extremities were applied to both extremities.

No intervention was made to the patients in the control group.

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.
Femoral Artery Flow Doppler Ultrasonography
Femoral artery flow evaluated by radiologist. The femoral artery flow unit is in ml/sn (milliliter/second). Peak systolic and end diastolic flow rates were measured by spectral examination
Six minute walk test
The six minute walk test unit is in m(meter) During the test, the patient is asked to walk as fast as he can without running, and the total distance he/she walks is measured after 6 minutes. The walking area must be at least 30 m long. Standardized warnings are used during testing. The test is terminated immediately in case of chest pain, intolerable dyspnea, leg cramps, extreme tiredness, sweating and pallor. It is possible to stop and rest during the test. As a result of the test, the total distance walked by the patient after six minutes was recorded

Secondary Outcome Measures

Full Information

First Posted
April 6, 2023
Last Updated
April 18, 2023
Sponsor
Kırıkkale University
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1. Study Identification

Unique Protocol Identification Number
NCT05837442
Brief Title
The Effect Of Osteopathic Manual Therapy On Arterial Circulation In Patients With Peripheral Arterial Disease
Official Title
The Effect Of Osteopathic Manual Therapy On Arterial Circulation In Patients With Peripheral Arterial Disease
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
August 1, 2017 (Actual)
Study Completion Date
December 20, 2018 (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
Peripheral artery disease (PAD) is a chronic atherosclerotic process that causes narrowing of peripheral arterial vessels in the lower extremities. Osteopathic manual therapy (OMT) is one of the new treatment options for various pathologies. The aim of this study was to investigate the effect of OMT on arterial circulation in patients with PAD.
Detailed Description
Peripheral arterial disease (PAD) is a chronic, atherosclerotic process in the lower extremities that causes narrowing of the peripheral arteries. It has a prevalence of up to 10% worldwide, this rate rises to about 30% in patients over 50 years of age. Atherosclerosis is characterized by intimal lesions called atheromas or atheromatous or fibrous fatty plaques that protrude into the vascular lumen, weakening the underlying environment. In atherosclerotic disease of the lower extremities, arterial stenoses cause a gradual reduction of prolonged blood flow, which manifests clinically as pain and tissue loss. Many patients with PAD are asymptomatic. The earliest symptom of the disease is pain while walking and is known as intermittent claudication (IC). If IC left untreated, it can cause pain at rest, tissue loss, or gangrene. Risk factors for peripheral arterial disease can be listed as age, gender, ethnicity, smoking, diabetes, hypertension, hyperlipidemia, chronic kidney failure. Understanding the underlying pathophysiological mechanisms of atherosclerosis and the finding of intermittent claudication in PAD is essential to be aware of the whole process and recommend prevention and treatment strategies. Patients with a diagnosis of PAH should receive a comprehensive treatment program, including structural exercise and lifestyle modification, to reduce cardiovascular ischemic events and improve functional status. All treatment plans should include aggressive modification of risk factors. This includes smoking cessation, weight loss, diet, hyperlipidemia, hypertension, diabetes, homocysteine, inflammation, antiplatelet medication, exercise. Recently, manual therapy methods have also been used. Andrew Taylor Still, founder of osteopathic manual therapy (OMT), was born on August 6, 1828, in Jonesville. He developed a strong belief in God as the perfect creator of all things. Because of this, he had the belief that all creation, including the human body, is perfect. He stated that a perfect body can heal itself and will contain the necessary tools for this. In OMT, 5 models are used to treat the person: biomechanic, respiratory-circulatory, metabolic-energy, neurological and behavioral. The circulatory model is concerned with the maintenance and enhancement of the extracellular environments through the delivery of oxygen and nutrients and the removal of cellular waste products. In this model, the clinical goal is to identify and eliminate key tissue stresses that impede the flow or circulation of body fluids to positively impact tissue health. The circulatory model is one of three levers used in the treatment of systemic dysfunction. In this model, coordinated OMT allows to improve homeostasis. These effects are known to be caused by nitric oxide (NO). Salomon et al. concluded that mechanical stimulation of excised neural and vascular tissue stimulates NO release, based on the data they obtained in their laboratory. Stimulation of muscle structure within physiological limits by manual techniques causes NO synthase enzyme activation, followed by NO release in a short time. The effect of NO, which is released in a short time, can cause a longer-term physiological mechanisms, especially in vascular structures. NO regulates by reducing endothelial and immunocyte activation and adhesion, thereby performing vital physiological activities including vasodilation. This can act as a positive feedback mechanism that causes the amount of blood flow to increase. As a result of NO-induced vasodilation, the organism has the potential to protect itself from microorganisms and physiological disorders such as hypertension. Vasodilation modulated by NO also reduces endothelial dysfunction. There are studies in the literature reporting that manual therapy interventions contribute to the systemic circulation, but only one study in which OMT was applied in patients with PAH was found. In this study, patients' ABI, functional performance, quality of life and some blood parameters were evaluated. No data was performed on arterial diameter and flow in the affected extremity. Considering the NO-induced vasodilator effects of OMT, it can be thought that it may increase circulation and change arterial diameter and flow in patients with PAD. Purpose of this study, to investigate the effect of osteopathic manual therapy on arterial circulation in patients with PAD.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease, Osteopathy in Diseases Classified Elsewhere
Keywords
peripheral arterial disease, osteopathic manual therapy, artery diameter, arterial flow

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
28 Patients were included. All of the patients included in the study were informed about the process. Voluntary consent was obtained from the patients participating in the study. 14 of the patients were randomly assigned to the osteopathic manual therapy group (OMTG) and 14 to the control group (CG).
Masking
ParticipantInvestigator
Masking Description
In this double-blind study, the physician who performed the radiological evaluation was unaware of which group the individual belonged to, and the patients were unaware of which group they belonged to.
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Osteopathic Manual Therapy Group (OMTG)
Arm Type
Experimental
Arm Description
The total duration of all techniques applied is 30 minutes. The techniques used in the extremities were applied to both extremities.
Arm Title
Control Group (CG)
Arm Type
No Intervention
Arm Description
No intervention was made to the patients in the control group.
Intervention Type
Other
Intervention Name(s)
Osteopathic Manual Therapy
Intervention Description
Occipital release, supraclavicular release, sternum mobilization, omentum minus release, liver pumping, diaphragm mobilization, grand maneuver for 3 minutes, general osteopathic manual therapy of the hip, knee and ankle was applied to each extremity for 90 seconds for a total of 3 minutes
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.
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). Peak systolic and end diastolic flow rates were measured by spectral examination
Time Frame
10 minutes
Title
Six minute walk test
Description
The six minute walk test unit is in m(meter) During the test, the patient is asked to walk as fast as he can without running, and the total distance he/she walks is measured after 6 minutes. The walking area must be at least 30 m long. Standardized warnings are used during testing. The test is terminated immediately in case of chest pain, intolerable dyspnea, leg cramps, extreme tiredness, sweating and pallor. It is possible to stop and rest during the test. As a result of the test, the total distance walked by the patient after six minutes was recorded
Time Frame
6 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: diagnosed with PAD, clinical onset of the disease for at least 3 months, ABI value between 0.4 and 1.4, Grade 2b according to Fontaine classification system, Exclusion Criteria: vascular or endovascular surgery in the last 3 months, unstable angina, myocardial infarction (MI), stroke, heart failure, significant hepatic or renal failure (dialysis-related etc.), acute infectious disease, 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
Kirikkale University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation
City
Kirikkale
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17140820
Citation
Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FG; TASC II Working Group; Bell K, Caporusso J, Durand-Zaleski I, Komori K, Lammer J, Liapis C, Novo S, Razavi M, Robbs J, Schaper N, Shigematsu H, Sapoval M, White C, White J, Clement D, Creager M, Jaff M, Mohler E 3rd, Rutherford RB, Sheehan P, Sillesen H, Rosenfield K. Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). Eur J Vasc Endovasc Surg. 2007;33 Suppl 1:S1-75. doi: 10.1016/j.ejvs.2006.09.024. Epub 2006 Nov 29. No abstract available.
Results Reference
background
PubMed Identifier
24582096
Citation
Mascarenhas JV, Albayati MA, Shearman CP, Jude EB. Peripheral arterial disease. Endocrinol Metab Clin North Am. 2014 Mar;43(1):149-66. doi: 10.1016/j.ecl.2013.09.003.
Results Reference
background
PubMed Identifier
7674694
Citation
Kannel WB, Wilson PW. An update on coronary risk factors. Med Clin North Am. 1995 Sep;79(5):951-71. doi: 10.1016/s0025-7125(16)30016-5.
Results Reference
background
PubMed Identifier
25908726
Citation
Hiatt WR, Armstrong EJ, Larson CJ, Brass EP. Pathogenesis of the limb manifestations and exercise limitations in peripheral artery disease. Circ Res. 2015 Apr 24;116(9):1527-39. doi: 10.1161/CIRCRESAHA.116.303566.
Results Reference
background
PubMed Identifier
29150158
Citation
Conte SM, Vale PR. Peripheral Arterial Disease. Heart Lung Circ. 2018 Apr;27(4):427-432. doi: 10.1016/j.hlc.2017.10.014. Epub 2017 Nov 7.
Results Reference
background
PubMed Identifier
8838905
Citation
Degenhardt BF, Kuchera ML. Update on osteopathic medical concepts and the lymphatic system. J Am Osteopath Assoc. 1996 Feb;96(2):97-100. doi: 10.7556/jaoa.1996.96.2.97.
Results Reference
background
PubMed Identifier
12429383
Citation
Backer M, Hammes MG, Valet M, Deppe M, Conrad B, Tolle TR, Dobos G. Different modes of manual acupuncture stimulation differentially modulate cerebral blood flow velocity, arterial blood pressure and heart rate in human subjects. Neurosci Lett. 2002 Nov 29;333(3):203-6. doi: 10.1016/s0304-3940(02)01109-6. Erratum In: Neurosci Lett. 2003 Feb 6;337(2):117.
Results Reference
background
PubMed Identifier
15289898
Citation
Salamon E, Zhu W, Stefano GB. Nitric oxide as a possible mechanism for understanding the therapeutic effects of osteopathic manipulative medicine (Review). Int J Mol Med. 2004 Sep;14(3):443-9.
Results Reference
background
PubMed Identifier
10739087
Citation
Stefano GB, Goumon Y, Bilfinger TV, Welters ID, Cadet P. Basal nitric oxide limits immune, nervous and cardiovascular excitation: human endothelia express a mu opiate receptor. Prog Neurobiol. 2000 Apr;60(6):513-30. doi: 10.1016/s0301-0082(99)00038-6.
Results Reference
background
PubMed Identifier
24614605
Citation
Walkowski S, Singh M, Puertas J, Pate M, Goodrum K, Benencia F. Osteopathic manipulative therapy induces early plasma cytokine release and mobilization of a population of blood dendritic cells. PLoS One. 2014 Mar 10;9(3):e90132. doi: 10.1371/journal.pone.0090132. eCollection 2014.
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
19336762
Citation
Noll DR. Short-term hematologic and hemodynamic effects of osteopathic lymphatic techniques. J Am Osteopath Assoc. 2009 Mar;109(3):121-2; author reply 122-3. No abstract available.
Results Reference
background
PubMed Identifier
30476991
Citation
Kilgore T, Malia M, Di Giacinto B, Minter S, Samies J. Adjuvant Lymphatic Osteopathic Manipulative Treatment in Patients With Lower-Extremity Ulcers: Effects on Wound Healing and Edema. J Am Osteopath Assoc. 2018 Dec 1;118(12):798-805. doi: 10.7556/jaoa.2018.172.
Results Reference
background

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The Effect Of Osteopathic Manual Therapy On Arterial Circulation In Patients With Peripheral Arterial Disease

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