Ultrasonographic Evaluation of Osteopathic Manipulation for Thoracic Outlet Syndrome
- Conditions
- Thoracic Outlet Syndrome
- Interventions
- Other: Osteopathic Manipulative Treatment (OMT)
- Registration Number
- NCT06273969
- Lead Sponsor
- A.T. Still University of Health Sciences
- 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 14
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Osteopathic Manipulative Treatment Osteopathic Manipulative Treatment (OMT) The OMT protocol is designed to target the somatic dysfunction associated with TOS.
- Primary Outcome Measures
Name Time Method Blood flow changes in the upper extremity. 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. Changes in blood flow to the upper extremity in participants who have been experiencing TOS symptoms.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
A.T. Still University
🇺🇸Kirksville, Missouri, United States