Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01342068 |
| Other study ID # |
TOS-Dx and Tx |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
April 25, 2011 |
| Last updated |
April 24, 2013 |
| Start date |
June 2011 |
| Est. completion date |
April 2013 |
Study information
| Verified date |
February 2013 |
| Source |
Nova Southeastern University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
United States: Institutional Review Board |
| Study type |
Observational
|
Clinical Trial Summary
Thoracic Outlet Syndrome (TOS) is a condition causing numbness, tingling and weakness in
patient's 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 patient's 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 (Adson's, Wright's
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.
Description:
In today's 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 medicine/therapy 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. Today's technological advancements can help provide more information
about the patient's 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 0.17% to 0.74%
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 patient's 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 patient's 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 orthopaedic/special tests and to
extrapolate our results to all educators and health care professionals that diagnose TOS.
In today's 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 medicine/therapy 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. Today's technological advancements can help provide more information
about the patient's 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 0.17% to 0.74%
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 patient's 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
patient's 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 orthopaedic/special tests and to
extrapolate our results to all educators and health care professionals that diagnose TOS.
