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

NCT05837442 | Completed

• 1 other identifier: OMT on PAD
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Arterial Disease; Osteopathy in Diseases Classified Elsewhere

Keywords

peripheral arterial disease; osteopathic manual therapy; artery diameter; arterial flow

Outcome Measures

Primary Outcomes (3)

• 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.

  10 minutes

• 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

  10 minutes

• 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

  6 minutes

Study Arms (2)

Osteopathic Manual Therapy Group (OMTG)

EXPERIMENTAL

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

Other: Osteopathic Manual Therapy

Control Group (CG)

NO INTERVENTION

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

Interventions

Osteopathic Manual Therapy 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

Osteopathic Manual Therapy Group (OMTG)

Eligibility Criteria

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

You may qualify if:

• 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,

You may not qualify if:

• 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

Sponsors & Collaborators

• Kırıkkale University: lead

Study Sites (1)

Kirikkale University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation

Kırıkkale, Turkey (Türkiye)

Location

Related Publications (13)

• 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.

  PMID: 17140820 BACKGROUND

• 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.

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• 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.

  PMID: 7674694 BACKGROUND

• 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.

  PMID: 25908726 BACKGROUND

• 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.

  PMID: 29150158 BACKGROUND

• 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.

  PMID: 8838905 BACKGROUND

• 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.

  PMID: 12429383 BACKGROUND

• 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.

  PMID: 15289898 BACKGROUND

• 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.

  PMID: 10739087 BACKGROUND

• 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.

  PMID: 24614605 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

• 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.

  PMID: 19336762 BACKGROUND

• 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.

  PMID: 30476991 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: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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).

Study Record Dates

• First Submitted: April 6, 2023
• First Posted: May 1, 2023
• Study Start: May 1, 2017
• Primary Completion: August 1, 2017
• Study Completion: December 20, 2018
• Last Updated: May 1, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)