Viewing Study NCT01342068



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Last Modification Date: 2024-10-26 @ 10:34 AM
Study NCT ID: NCT01342068
Status: COMPLETED
Last Update Posted: 2013-04-25
First Post: 2011-04-25

Brief Title: The Effectiveness of Diagnosis and Treatment of Thoracic Outlet Syndrome
Sponsor: Nova Southeastern University
Organization: Nova Southeastern University

Study Overview

Official Title: The Effectiveness of Diagnosis and Treatment of Thoracic Outlet Syndrome
Status: COMPLETED
Status Verified Date: 2013-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Thoracic Outlet Syndrome TOS is a condition causing numbness tingling and weakness in patients upper limbs Symptoms are due to compression and restriction of the nerves and blood vessels neurovascular bundle that extend from the neck into the upper limb exerted by a patients various anatomical structures Neurovascular bundle compression can result in decreased nerve conduction and blood flow through the arteries supplying structures downstream from the restricted site These anatomical restrictions include tight scalene muscles in the neck tightened pectorialis minor muscle in the chest and extra ribs growing from the C7 vertebra

TOS can be diagnosed by using special tests designed to re-elicit neurovascular bundle compression Upon obtaining a positive test the patient can undergo osteopathic manipulative treatments OMT to change the anatomical restrictions allowing for a decrease of symptoms and even eradication of the syndrome altogether

Although diagnosis and treatment of TOS is common in osteopathic medicine the effectiveness of the diagnostic special tests and treatment has not been thoroughly investigated This study aims to examine the effectiveness of the special tests Adsons Wrights hyperabduction and Halstead maneuver in diagnosing a change in blood flow through the arteries of the upper arm compared to evaluation with Doppler ultrasound to measure blood flow while the tests are performed Patients with positive tests will be treated with OMT including myofascial release soft tissue and articulation to relieve restricting structures Upon completion of treatment the special tests will be performed again along with the Doppler ultrasound to measure blood flow through blood vessels Results then are analyzed statistically for significance of the ability correctly diagnose and treat TOS symptoms

Results from this study will contribute towards the validity of teaching special tests in osteopathic medical schools and allow for a non-invasive treatment protocol for patients with TOS
Detailed Description: In todays hectic society it becomes a great disadvantage to individuals when they develop pain and discomfort that decreases their ability to function efficiently Thoracic Outlet Syndrome TOS is a condition that causes pain in the upper extremity typically extending along the inner aspect of the arm and hand Other symptoms include weakness numbness and tingling in the upper extremity A neurovascular bundle that consists of the brachial plexus subclavian artery and vein travels from the neck into the arm TOS symptoms result when the nerves or blood vessels are compressed by the surrounding anatomical structures In performing this research study our team would like to improve awareness of TOS to all health care professionals as an entrapment neuropathy and differential diagnosis to neck pain with referred pain We would also like to bring osteopathic medicine physical therapy and other paradigms of musculoskeletal manual medicinetherapy together to develop a standardized and valid approach to the diagnosis and treatment of TOS which is not currently available

There are multiple possible causes of TOS majority of which results in anatomic restrictions These possible causes include trauma to the shoulder girdle and more commonly postural disturbances Individuals with TOS often sit at a computer or desk for an extended period of time for work or school They develop rounded shoulders and a forward head carriage which changes the length and tone of certain muscles and the relationship of structures in relation to the neurovascular bundle The anatomic disturbances that contribute and is of the greatest interest to osteopathy includes hypertonicity of the anterior and middle scalene muscles in the neck hypertonicity of the pectorialis muscle from the upper extremity to the 3-5th ribs somatic dysfunctions of the clavicle upper thoracic region and ribs especially the first rib Ward 2003

TOS is often the resulting diagnosis after elimination of other possible conditions that cause similar symptoms These other possible conditions include disc herniations osteoarthritis tumors and nerve entrapment syndromes such as carpal tunnel syndrome Currently discrepancies exist between clinicians about the correct approaches to diagnosis and treatment of TOS Todays technological advancements can help provide more information about the patients anatomy however none can be used for diagnosis alone MRIs are usually best used for confirmation for the evaluation of the region of interest however in TOS findings are frequently inconclusive One reason for this may be the difficulty to evaluate the extent of a muscle spasm or rib somatic dysfunction and the degree to which it is compressing a nerve structure Koknel 2005 X-rays are used to eliminate extra ribs in the cervical region as a cause for symptoms Anomalous cervical ribs are found in 017 to 074 each year however only 10 of individuals experience TOS symptoms and the onset of these symptoms often relates to cervical spine trauma Novak Mackinnon 2002 The diagnosis of TOS remains to be best based on the patients subjective complaints physical examination and the exclusion of other pathologies Novak Mackinnon 2002 Clinical assessment of TOS is best achieved by reproduction of symptoms with compression and special orthopaedic provocative tests that re-produces symptoms based on patient position Koknel 2005

These orthopedic special tests will include

Wright Test See picture appendix 2 Wright Test or Hyperabduction Test is done by bringing the arm into full abduction with the shoulder externally rotated and the elbow extended while monitoring the radial pulse throughout Magee DJ 2008 If there is a decrease or absence of pulse the test is positive showing that axillary artery is compressed by either the pectoralis minor muscle or the coracoid process Köknel Talu G 2005

Adson Test See picture appendix 3 For Adson Maneuver the examiner externally rotates and extends the effected arm with the elbow extended while monitoring the radial pulse The patient is then instructed to rotate the head toward the affected side extend the neck and take a deep breath and hold it The absence of disappearance of a pulse indicates a positive test Magee DJ 2008 In 1947 Adson first described this test with the explanation that an alteration of the radial pulse or an alteration in blood pressure is considered a pathognomonic sign of scalenus anticus syndrome indicating that the vascular component of neurovascular bundle is compressed by scalenus anticus muscle Mackinnon SE 2002

Halstead Maneuver See picture appendix 4 The Reverse-Adson Maneuver or Halstead Maneuver is also done with the patients arm externally rotated and extended with the elbow extended The examiner monitors the radial pulse as the patient rotates the head away from the affected side and extends the neck The patient is instructed to take a deep breath and hold it The absence or disappearance of a pulse indicates a positive test a suggesting the presence of a cervical rib Magee DJ 2008

Roos Test See picture appendix 5 This test will be used to screen interested participants during the recruitment phase The patient stands and abducts the arms to 90 degrees externally rotates the shoulder and flexes the elbows to 90 degrees The patient is then directed to open and close the hands slowly for three minutes A positive test will cause increased symptoms such as ischemic pain heaviness or profound weakness of the arm or numbness and tingling of the hand Minor fatigue is considered a negative test Magee DJ 2008 Positive findings indicate compression of the neurovascular bundle specific to structures in the thoracic outlet

In previous studies testing the efficacy of the TOS special tests Doppler ultrasonography was shown to visualize vascular abnormalities and confirmed the diagnosis in patients with at least five positive provocative special tests Gillard Perez-Cousin Hachulla Remy et al 2001 Our research team would like to confirm this previous finding and further expand on this topic by examining for the changes in blood flow with Doppler ultrasonography during the performance of these special tests

Diagnostic ultrasound has been in use since the late 1950s There are no confirmed adverse biological effects on patients from this usage Although no hazard has been identified that would limit the use of diagnostic ultrasound on patients in education and research experience from normal diagnostic practice may or may not experience hazards due to extended exposure times and altered conditions Participants enrolled in this study will be informed about the anticipated exposure conditions and how these compare with normal diagnostic practice AIUM 2007

In addition to evaluation of the effectiveness of the TOS special tests the effects of Osteopathic manipulative treatment OMT to help alleviate TOS symptoms is also of interest OMT of TOS is directed towards improving mechanics of the cervical upper thoracic spine upper ribs clavicles and muscles of the neck shoulder and pectoral girdle OMT procedures such as myofascial release and articulatory techniques can be useful in reducing the dysfunctions of these regions which is causing compression on the nerve Myofascial release involves manipulating the soft tissues articulation is taking a joint through its available range of motion to improve its normal physiological movement Ward 2003 By performing this research we can improve the body of research in osteopathic manipulative medicine OMM and provide a proven means of treating the pain experienced by individuals with TOS

TOS diagnosis and treatment is taught to osteopathic medical students physical therapy students as well as other health professionals that employ manual therapy strategies to diagnose and treat musculoskeletal disorders Despite this information being included as part of the education of these health care professionals there is little literature outside of patient anecdotes that supports the reliability and validity of these tests and treatments We hope to contribute towards increasing the evidence of these tests and treatments for TOS to ensure that students especially those at the health professions division at NSU will be educated on reliable and proven orthopaedicspecial tests and to extrapolate our results to all educators and health care professionals that diagnose TOS

In todays hectic society it becomes a great disadvantage to individuals when they develop pain and discomfort that decreases their ability to function efficiently Thoracic Outlet Syndrome TOS is a condition that causes pain in the upper extremity typically extending along the inner aspect of the arm and hand Other symptoms include weakness numbness and tingling in the upper extremity A neurovascular bundle that consists of the brachial plexus subclavian artery and vein travels from the neck into the arm TOS symptoms result when the nerves or blood vessels are compressed by the surrounding anatomical structures In performing this research study our team would like to improve awareness of TOS to all health care professionals as an entrapment neuropathy and differential diagnosis to neck pain with referred pain We would also like to bring osteopathic medicine physical therapy and other paradigms of musculoskeletal manual medicinetherapy together to develop a standardized and valid approach to the diagnosis and treatment of TOS which is not currently available

There are multiple possible causes of TOS majority of which results in anatomic restrictions These possible causes include trauma to the shoulder girdle and more commonly postural disturbances Individuals with TOS often sit at a computer or desk for an extended period of time for work or school They develop rounded shoulders and a forward head carriage which changes the length and tone of certain muscles and the relationship of structures in relation to the neurovascular bundle The anatomic disturbances that contribute and is of the greatest interest to osteopathy includes hypertonicity of the anterior and middle scalene muscles in the neck hypertonicity of the pectorialis muscle from the upper extremity to the 3-5th ribs somatic dysfunctions of the clavicle upper thoracic region and ribs especially the first rib Ward 2003

TOS is often the resulting diagnosis after elimination of other possible conditions that cause similar symptoms These other possible conditions include disc herniations osteoarthritis tumors and nerve entrapment syndromes such as carpal tunnel syndrome Currently discrepancies exist between clinicians about the correct approaches to diagnosis and treatment of TOS Todays technological advancements can help provide more information about the patients anatomy however none can be used for diagnosis alone MRIs are usually best used for confirmation for the evaluation of the region of interest however in TOS findings are frequently inconclusive One reason for this may be the difficulty to evaluate the extent of a muscle spasm or rib somatic dysfunction and the degree to which it is compressing a nerve structure Koknel 2005 X-rays are used to eliminate extra ribs in the cervical region as a cause for symptoms Anomalous cervical ribs are found in 017 to 074 each year however only 10 of individuals experience TOS symptoms and the onset of these symptoms often relates to cervical spine trauma Novak Mackinnon 2002 The diagnosis of TOS remains to be best based on the patients subjective complaints physical examination and the exclusion of other pathologies Novak Mackinnon 2002 Clinical assessment of TOS is best achieved by reproduction of symptoms with compression and special orthopaedic provocative tests that re-produces symptoms based on patient position Koknel 2005

These orthopedic special tests will include

Wright Test Wright Test or Hyperabduction Test is done by bringing the arm into full abduction with the shoulder externally rotated and the elbow extended while monitoring the radial pulse throughout Magee DJ 2008 If there is a decrease or absence of pulse the test is positive showing that axillary artery is compressed by either the pectoralis minor muscle or the coracoid process Köknel Talu G 2005

Adson Test For Adson Maneuver the examiner externally rotates and extends the effected arm with the elbow extended while monitoring the radial pulse The patient is then instructed to rotate the head toward the affected side extend the neck and take a deep breath and hold it The absence of disappearance of a pulse indicates a positive test Magee DJ 2008 In 1947 Adson first described this test with the explanation that an alteration of the radial pulse or an alteration in blood pressure is considered a pathognomonic sign of scalenus anticus syndrome indicating that the vascular component of neurovascular bundle is compressed by scalenus anticus muscle Mackinnon SE 2002

Halstead Maneuver The Reverse-Adson Maneuver or Halstead Maneuver is also done with the patients arm externally rotated and extended with the elbow extended The examiner monitors the radial pulse as the patient rotates the head away from the affected side and extends the neck The patient is instructed to take a deep breath and hold it The absence or disappearance of a pulse indicates a positive test a suggesting the presence of a cervical rib Magee DJ 2008

Roos Test This test will be used to screen interested participants during the recruitment phase The patient stands and abducts the arms to 90 degrees externally rotates the shoulder and flexes the elbows to 90 degrees The patient is then directed to open and close the hands slowly for three minutes A positive test will cause increased symptoms such as ischemic pain heaviness or profound weakness of the arm or numbness and tingling of the hand Minor fatigue is considered a negative test Magee DJ 2008 Positive findings indicate compression of the neurovascular bundle specific to structures in the thoracic outlet

In previous studies testing the efficacy of the TOS special tests Doppler ultrasonography was shown to visualize vascular abnormalities and confirmed the diagnosis in patients with at least five positive provocative special tests Gillard Perez-Cousin Hachulla Remy et al 2001 Our research team would like to confirm this previous finding and further expand on this topic by examining for the changes in blood flow with Doppler ultrasonography during the performance of these special tests

Diagnostic ultrasound has been in use since the late 1950s There are no confirmed adverse biological effects on patients from this usage Although no hazard has been identified that would limit the use of diagnostic ultrasound on patients in education and research experience from normal diagnostic practice may or may not experience hazards due to extended exposure times and altered conditions Participants enrolled in this study will be informed about the anticipated exposure conditions and how these compare with normal diagnostic practice AIUM 2007

In addition to evaluation of the effectiveness of the TOS special tests the effects of Osteopathic manipulative treatment OMT to help alleviate TOS symptoms is also of interest OMT of TOS is directed towards improving mechanics of the cervical upper thoracic spine upper ribs clavicles and muscles of the neck shoulder and pectoral girdle OMT procedures such as myofascial release and articulatory techniques can be useful in reducing the dysfunctions of these regions which is causing compression on the nerve Myofascial release involves manipulating the soft tissues articulation is taking a joint through its available range of motion to improve its normal physiological movement Ward 2003 By performing this research we can improve the body of research in osteopathic manipulative medicine OMM and provide a proven means of treating the pain experienced by individuals with TOS

TOS diagnosis and treatment is taught to osteopathic medical students physical therapy students as well as other health professionals that employ manual therapy strategies to diagnose and treat musculoskeletal disorders Despite this information being included as part of the education of these health care professionals there is little literature outside of patient anecdotes that supports the reliability and validity of these tests and treatments We hope to contribute towards increasing the evidence of these tests and treatments for TOS to ensure that students especially those at the health professions division at NSU will be educated on reliable and proven orthopaedicspecial tests and to extrapolate our results to all educators and health care professionals that diagnose TOS

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None