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

NCT ID: NCT05837442

Last Updated: 2023-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-01
• Study Completion Date: 2018-12-20

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.

Conditions

Peripheral Arterial Disease; Osteopathy in Diseases Classified Elsewhere

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Osteopathic Manual Therapy Group (OMTG)

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

Group Type: EXPERIMENTAL

Osteopathic Manual Therapy

Intervention Type: OTHER

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

Control Group (CG)

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Osteopathic Manual Therapy

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kırıkkale University

OTHER

Sponsor Role: lead

Responsible Party

Muhammet Ayhan ORAL

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

MUHAMMET AYHAN ORAL

Role: PRINCIPAL_INVESTIGATOR

Kırıkkale University

Locations

Kirikkale University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation

Kırıkkale, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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Other Identifiers

OMT on PAD

Identifier Type: -

Identifier Source: org_study_id