Thoracic Outlet SyndromeTOSNCT06273969
Ultrasonographic Evaluation of Osteopathic Manipulation for Thoracic Outlet Syndrome
A study testing Osteopathic Manipulative Treatment (OMT) in people with Thoracic Outlet Syndrome, run by A.T. Still University of Health Sciences at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Thoracic Outlet Syndrome
- What is being tested?
- Osteopathic Manipulative Treatment (OMT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2024to 3 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Protocol Development for Ultrasonographic Evaluation of the Effect of Osteopathic Manipulative Techniques on Thoracic Outlet Syndrome
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.
Read the 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.
- Conditions
- Thoracic Outlet Syndrome
- Being tested
- Osteopathic Manipulative Treatment (OMT)
- Keywords
- Blood Flow, Osteopathic Manipulation, Ultrasonography
- Medical subject headings
- Thoracic Outlet Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Osteopathic Manipulative Treatment | Experimental | The OMT protocol is designed to target the somatic dysfunction associated with TOS. Receives: Other: Osteopathic Manipulative Treatment (OMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood flow changes in the upper extremity.
Changes in blood flow to the upper extremity in participants who have been experiencing TOS symptoms.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start1 Apr 2024
- Primary completion3 Apr 2024
- Study completion3 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Thoracic Outlet SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- A.T. Still University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Kondrashov, PhD, Principal investigator, A.T. Still University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06273969
- Sponsor's protocol ID
- PK20240105-001
- Acronym
- TOS
- Status last verified
- Jul 2024
- First submitted
- 2 Feb 2024
- Last updated
- 24 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24909503Cocco 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.
PubMed 37166516Kimberly PE, Halma K. Outline of osteopathic manipulative procedures: the Kimberly manual 2006. Marceline (MO): Walsworth Publishing; 2008.
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.
Dalley AF 2nd, Agur AMR. Moore's clinically oriented anatomy. 9th ed. Philadelphia (PA); Wolters Kluwer; 2023.
Nicholas AS, Nocholas EA. Atlas of osteopathic techniques. 4th ed. Philadelphia (PA): Wolters Kluwer; 2023.
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.
PubMed 27568153Huang JH, Zager EL. Thoracic outlet syndrome. Neurosurgery. 2004 Oct;55(4):897-902; discussion 902-3. doi: 10.1227/01.neu.0000137333.04342.4d.
PubMed 15458598Lapegue 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.
PubMed 24603038Moore R, Wei Lum Y. Venous thoracic outlet syndrome. Vasc Med. 2015 Apr;20(2):182-9. doi: 10.1177/1358863X14568704.
PubMed 25832605Pisko-Dubienski ZA, Hollingsworth J. Clinical application of Doppler ultrasonography in the thoracic outlet syndrome. Can J Surg. 1978 Mar;21(2):145-7, 150.
PubMed 630465Stapleton 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.
PubMed 17928256Sucher 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.
PubMed 21955534Vemuri 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.
PubMed 28189360Wadhwani 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.
PubMed 11444739
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol Development for Ultrasonographic Evaluation of the Effect of Osteopathic Manipulative Techniques on Thoracic Outlet Syndrome
- ClinicalTrials.gov ID
- NCT06273969
- Acronym / sponsor ID
- TOS / PK20240105-001
- Conditions
- Thoracic Outlet Syndrome
- Keywords
- Blood Flow, Osteopathic Manipulation, Ultrasonography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- A.T. Still University of Health SciencesUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 3 Apr 2024 (actual)
- Study completion
- 3 Apr 2024 (actual)
- First posted
- 23 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Osteopathic Manipulative Treatment | Experimental | Other: Osteopathic Manipulative Treatment (OMT)The OMT protocol is designed to target the somatic dysfunction associated with TOS. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osteopathic Manipulative Treatment (OMT)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 | Other | Osteopathic Manipulative Treatment |
Primary outcome
Blood flow changes in the upper extremity.
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
- Background: PubMed 24909503Chen 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.
- Background: PubMed 37166516Cocco 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.
- BackgroundKimberly PE, Halma K. Outline of osteopathic manipulative procedures: the Kimberly manual 2006. Marceline (MO): Walsworth Publishing; 2008.
- BackgroundKuchera 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.
- BackgroundDalley AF 2nd, Agur AMR. Moore's clinically oriented anatomy. 9th ed. Philadelphia (PA); Wolters Kluwer; 2023.
- BackgroundNicholas AS, Nocholas EA. Atlas of osteopathic techniques. 4th ed. Philadelphia (PA): Wolters Kluwer; 2023.
- Background: PubMed 27568153Hussain 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.
- Background: PubMed 15458598Huang JH, Zager EL. Thoracic outlet syndrome. Neurosurgery. 2004 Oct;55(4):897-902; discussion 902-3. doi: 10.1227/01.neu.0000137333.04342.4d.
- Background: PubMed 24603038Lapegue 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.
- Background: PubMed 25832605Moore R, Wei Lum Y. Venous thoracic outlet syndrome. Vasc Med. 2015 Apr;20(2):182-9. doi: 10.1177/1358863X14568704.
- Background: PubMed 630465Pisko-Dubienski ZA, Hollingsworth J. Clinical application of Doppler ultrasonography in the thoracic outlet syndrome. Can J Surg. 1978 Mar;21(2):145-7, 150.
- Background: PubMed 17928256Stapleton 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Kondrashov, PhD principal investigator
A.T. Still University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteopathic Manipulative Treatment (OMT) in people with Thoracic Outlet Syndrome, run by A.T. Still University of Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood flow changes in the upper extremity. (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06273969, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2024.