Ultrasonographic Evaluation of Osteopathic Manipulation for Thoracic Outlet Syndrome

NCT06273969 | Completed

• 1 other identifier: PK20240105-001
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to develop a protocol to assess blood flow in the upper limb vasculature before and after osteopathic manipulative treatment (OMT) using Pulsed-wave Doppler ultrasonography (US). We will assess the subclavian artery and vein at two locations (above and below the clavicle) and the brachial artery and vein (within the axilla) to determine the reproducibility of the blood flow findings at each location and the impact of OMT on the blood flow. Additionally we will qualitatively assess morphological changes of the brachial plexus before and after OMT with US.

Conditions

Thoracic Outlet Syndrome

Keywords

Blood Flow; Osteopathic Manipulation; Ultrasonography

Outcome Measures

Primary Outcomes (1)

• Blood flow changes in the upper extremity.

  Changes in blood flow to the upper extremity in participants who have been experiencing TOS symptoms.

  Pre and post osteopathic manipulative treatment on the day of treatment. Pre-measurement followed by 10 minutes of rest before OMT. Post-measurement made immediately following the OMT treatment.

Study Arms (1)

Osteopathic Manipulative Treatment

EXPERIMENTAL

The OMT protocol is designed to target the somatic dysfunction associated with TOS.

Other: Osteopathic Manipulative Treatment (OMT)

Interventions

Osteopathic Manipulative Treatment (OMT) OTHER

The OMT protocol is designed to target the somatic dysfunction associated with TOS. The somatic dysfunction associated with TOS include muscular hypertonicity of the anterior and middle scalene muscles, hypertonicity of the pectoralis muscles, and tension in the fascia of the supraclavicular area between the clavicle and first rib. The OMT protocol will consist of the following four techniques: Direct Thoracic Inlet Myofascial Release (TIMFR) - Reduce tension at the thoracic inlet fascia located between the thoracic outlet and the cervical spine. Direct Muscle Energy for the Scalene Muscles -Reduce tension within the scalene muscle group Direct Muscle Energy for the Pectoralis Muscles - Reduce tension within the pectoralis muscle group Supraclavicular Fascial Release - Reduce fascial tension within the supraclavicular fossa

Osteopathic Manipulative Treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women 18-65 years of age
• Experienced intermittent tingling and/or numbness in one or both hands that has occurred within two weeks of the start date of this study.

You may not qualify if:

• Pregnant
• Body mass index (BMI) over 30 kg/m2 (obese)
• Prior surgery, broken bones, or known birth defects affecting the thoracic outlet, such as clavicular fracture or congenital first rib

Sponsors & Collaborators

• A.T. Still University of Health Sciences: lead

Study Sites (1)

A.T. Still University

Kirksville, Missouri, 63548, United States

Location

Related Publications (19)

• Chen H, Baker N, Williams K, Criado E. Physiologic variations in venous and arterial hemodynamics in response to postural changes at the thoracic outlet in normal volunteers. Ann Vasc Surg. 2014 Oct;28(7):1583-8. doi: 10.1016/j.avsg.2014.05.003. Epub 2014 Jun 6.

  PMID: 24909503 BACKGROUND

• Cocco G, Ricci V, Ricci C, Nanka O, Catalano O, Corvino A, Boccatonda A, Serafini FL, Izzi J, Vallone G, Cantisani V, Iannetti G, Caulo M, Ucciferri C, Vecchiet J, Pizzi AD. Ultrasound imaging of the axilla. Insights Imaging. 2023 May 11;14(1):78. doi: 10.1186/s13244-023-01430-9.

  PMID: 37166516 BACKGROUND

• Kimberly PE, Halma K. Outline of osteopathic manipulative procedures: the Kimberly manual 2006. Marceline (MO): Walsworth Publishing; 2008.

  BACKGROUND

• Kuchera ML, Wallace E. Lymphatic drainage procedures. In: Seffinger MA, editor. Foundations of osteopathic medicine: philosophy, science, clinical applications, and research. 4th ed. Philadelphia (PA): Wolters Kluwer; 2018. p. 906-922.

  BACKGROUND

• Dalley AF 2nd, Agur AMR. Moore's clinically oriented anatomy. 9th ed. Philadelphia (PA); Wolters Kluwer; 2023.

  BACKGROUND

• Nicholas AS, Nocholas EA. Atlas of osteopathic techniques. 4th ed. Philadelphia (PA): Wolters Kluwer; 2023.

  BACKGROUND

• Hussain MA, Aljabri B, Al-Omran M. Vascular Thoracic Outlet Syndrome. Semin Thorac Cardiovasc Surg. 2016 Spring;28(1):151-7. doi: 10.1053/j.semtcvs.2015.10.008. Epub 2015 Oct 28.

  PMID: 27568153 BACKGROUND

• Huang JH, Zager EL. Thoracic outlet syndrome. Neurosurgery. 2004 Oct;55(4):897-902; discussion 902-3. doi: 10.1227/01.neu.0000137333.04342.4d.

  PMID: 15458598 BACKGROUND

• Lapegue F, Faruch-Bilfeld M, Demondion X, Apredoaei C, Bayol MA, Artico H, Chiavassa-Gandois H, Railhac JJ, Sans N. Ultrasonography of the brachial plexus, normal appearance and practical applications. Diagn Interv Imaging. 2014 Mar;95(3):259-75. doi: 10.1016/j.diii.2014.01.020. Epub 2014 Mar 3.

  PMID: 24603038 BACKGROUND

• Moore R, Wei Lum Y. Venous thoracic outlet syndrome. Vasc Med. 2015 Apr;20(2):182-9. doi: 10.1177/1358863X14568704.

  PMID: 25832605 BACKGROUND

• Pisko-Dubienski ZA, Hollingsworth J. Clinical application of Doppler ultrasonography in the thoracic outlet syndrome. Can J Surg. 1978 Mar;21(2):145-7, 150.

  PMID: 630465 BACKGROUND

• Stapleton C, Herrington L, George K. Sonographic evaluation of the subclavian artery during thoracic outlet syndrome shoulder manoeuvres. Man Ther. 2009 Feb;14(1):19-27. doi: 10.1016/j.math.2007.07.010. Epub 2007 Oct 24.

  PMID: 17928256 BACKGROUND

• Sucher BM. Ultrasonography-guided osteopathic manipulative treatment for a patient with thoracic outlet syndrome. J Am Osteopath Assoc. 2011 Sep;111(9):543-7. doi: 10.7556/jaoa.2011.111.9.543.

  PMID: 21955534 BACKGROUND

• Vemuri C, McLaughlin LN, Abuirqeba AA, Thompson RW. Clinical presentation and management of arterial thoracic outlet syndrome. J Vasc Surg. 2017 May;65(5):1429-1439. doi: 10.1016/j.jvs.2016.11.039. Epub 2017 Feb 8.

  PMID: 28189360 BACKGROUND

• Wadhwani R, Chaubal N, Sukthankar R, Shroff M, Agarwala S. Color Doppler and duplex sonography in 5 patients with thoracic outlet syndrome. J Ultrasound Med. 2001 Jul;20(7):795-801. doi: 10.7863/jum.2001.20.7.795.

  PMID: 11444739 BACKGROUND

• Yuschak E, Haq F, Chase S. A Case of Venous Thoracic Outlet Syndrome: Primary Care Review of Physical Exam Provocative Tests and Osteopathic Manipulative Technique Considerations. Cureus. 2019 Jun 17;11(6):e4921. doi: 10.7759/cureus.4921.

  PMID: 31423397 BACKGROUND

• Cavanna AC, Giovanis A, Daley A, Feminella R, Chipman R, Onyeukwu V. Thoracic outlet syndrome: a review for the primary care provider. J Osteopath Med. 2022 Aug 29;122(11):587-599. doi: 10.1515/jom-2021-0276. eCollection 2022 Nov 1.

  PMID: 36018621 BACKGROUND

• Jones MR, Prabhakar A, Viswanath O, Urits I, Green JB, Kendrick JB, Brunk AJ, Eng MR, Orhurhu V, Cornett EM, Kaye AD. Thoracic Outlet Syndrome: A Comprehensive Review of Pathophysiology, Diagnosis, and Treatment. Pain Ther. 2019 Jun;8(1):5-18. doi: 10.1007/s40122-019-0124-2. Epub 2019 Apr 29.

  PMID: 31037504 BACKGROUND

• Kim M, Chi EH, Lee J, Ha I. The clinical observation of muscle energy techniques of ligamentous articular strain in 2 cases of cervical disc herniation with thoracic outlet syndrome. Int J of Osteo Med. 2015; 18: 63-70.

  BACKGROUND

MeSH Terms

Conditions

Thoracic Outlet Syndrome

Interventions

Manipulation, Osteopathic

Condition Hierarchy (Ancestors)

Nerve Compression Syndromes; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Peter Kondrashov, PhD

  A.T. Still University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Twelve consented male and/or female volunteers between the ages of 18 and 65 with intermittent tingling and/or numbness in one or both hands that has occurred with two weeks of the start date of the study will be evaluated using pulsed-wave doppler ultrasonography (US) and then treated with osteopathic manipulative treatment (OMT). US examination of the thoracic outlet will be performed using a Mindray-6 ultrasound machine and will include 4 views/positions with the subject in a seated position. The following intervention will consist of four osteopathic manipulation techniques (OMT) being performed that target the somatic dysfunctions associated with TOS. These techniques include: 1) Direct Thoracic Inlet Myofascial Release (TIMFR); 2) Direct Muscle Energy for the Scalene Muscles; 3) Direct Muscle Energy for the Pectoralis Muscles; and 4) Supraclavicular Fascial Release.

Study Record Dates

• First Submitted: February 2, 2024
• First Posted: February 23, 2024
• Study Start: April 1, 2024
• Primary Completion: April 3, 2024
• Study Completion: April 3, 2024
• Last Updated: July 24, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)