Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

Thoracic outlet syndrome (TOS) includes a spectrum of symptoms caused by compression of neural or vascular structures in or near the superior thoracic aperture. TOS symptoms results when the subclavian vessels are obstructed or when the subclavian artery or vein, or brachial plexus are compressed by regional structures in or around the superior thoracic aperture causing numbness and tingling in the ipsilateral upper extremity. OMT is a type of manual therapeutic approach used in the osteopathic profession that can be used to reduce symptoms in patients with TOS, but the underlying mechanisms of the treatment are unclear. Manual techniques, such as thoracic inlet myofascial release, can be used as part of a OMT approach to free local musculoskeletal restrictions around the brachial plexus and vasculature entering and exiting the upper extremity. The current evidence for the use of OMT in management of TOS is primarily limited to case studies. More studies are required to determine whether OMT is effective and better understand why it might be effective. Currently, other treatments for TOS include physical therapy, trigger point injections, botulism injections, and acupuncture. Pharmacological treatments for TOS symptoms include muscle relaxants, antidepressants, anti-inflammatories such as NSAIDs and steroids, and anticoagulants-all of which have associated risks, contraindications, expenses, and side effects. Severe cases of TOS may require surgical decompression in the presence of severe symptoms that fail conservative treatments. OMT represents a quick conservative intervention that can be performed during an outpatient visit. US is a noninvasive tool that can be used to evaluate blood flow in arteries and veins. In patients with TOS, US has shown significant changes in blood flow dynamics of the subclavian vessels. Significant changes were also seen in the subclavian artery blood flow during shoulder maneuvers (e.g. Adson's test, Wright's test, Elevated Arm Stress test, Roos test) that are used in the diagnostics of TOS. Therefore, it would be reasonable to use US to assess possible mechanisms by which OMT might reduce symptoms. Such information would allow physicians to understand how to use OMT techniques most effectively, either as an adjunct to other treatments, or as standalone therapy. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06273969
Study type Interventional
Source A.T. Still University of Health Sciences
Contact Peter Kondrashov, PhD
Phone 660-626-2468
Email pkondrashov@atsu.edu
Status Not yet recruiting
Phase N/A
Start date April 1, 2024
Completion date April 24, 2024

See also
  Status Clinical Trial Phase
Recruiting NCT05426473 - Differences in Quality of Life After Thoracic Outlet Syndrome Surgery N/A
Completed NCT05441176 - TULIP et MASC : Premiers Usages N/A
Enrolling by invitation NCT05544721 - A Study of Paravertebral Block in Thoracic Outlet Syndrome Phase 4
Not yet recruiting NCT05536570 - Whiplash-induced Thoracic Outlet Syndrome Treated With Botulinum Toxin. Phase 4
Completed NCT05360303 - Electromyography in Thoracic Outlet Syndrome
Completed NCT06036888 - DEFILE-QoL5 - Evaluation of the Long-term Surgical Management of the Thoraco-brachial Displacement Syndrome
Recruiting NCT05628948 - Vascular Lab Resource (VLR) Biorepository
Completed NCT00444886 - Treatment of Thoracic Outlet Syndrome (TOS) With Botox Phase 2
Completed NCT06446141 - Effect of Osteopathic Technique on Respiratory Parameters and Pain in Thoracic Outlet Syndrome N/A
Active, not recruiting NCT03355274 - Systematic Transcutaneous Oxymetry Use in Thoracic Outlet Syndrome N/A
Recruiting NCT04428125 - CFD Analysis and Risk of TOS in Sport
Completed NCT05934734 - Influence of Thoracic Outlet Syndrome Severity on Upper Extremity Function and Neural Integrity
Completed NCT01342068 - The Effectiveness of Diagnosis and Treatment of Thoracic Outlet Syndrome N/A
Completed NCT01196637 - Thoracic Outlet Syndrome: Case Reports and Analysis With Ultrasound Imaging N/A
Enrolling by invitation NCT04054440 - Outpatient Office Based Endovascular Procedures
Recruiting NCT05917756 - Mobilization With Movement on Pain, Function, and Quality of Life in Patients With Thoracic Outlet Syndrome N/A
Recruiting NCT06095700 - First Rib Resection Versus Avulsion for Thoracic Outlet Syndrome N/A
Completed NCT05702866 - Vascular Compression Assessment Using Transcutaneous Oxymetry in Patients Suspected of Having Thoracic Outlet Syndrome
Recruiting NCT04376177 - Clinical Routine in Thoracic Outlet Syndrome
Terminated NCT03780647 - Assessment of the Impact of Thoracic Outlet Syndromes on the Performance at Work