Ignite Creation Date:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2025-12-30 @ 7:18 AM
Study NCT ID:
NCT06273969
Status:
COMPLETED
Last Update Posted:
2024-07-24
First Post:
2024-02-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasonographic Evaluation of Osteopathic Manipulation for Thoracic Outlet Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013901', 'term': 'Thoracic Outlet Syndrome'}], 'ancestors': [{'id': 'D009408', 'term': 'Nerve Compression Syndromes'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D026301', 'term': 'Manipulation, Osteopathic'}], 'ancestors': [{'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': '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).\n\nUS 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.\n\nThe 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.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-04-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-23', 'studyFirstSubmitDate': '2024-02-02', 'studyFirstSubmitQcDate': '2024-02-21', 'lastUpdatePostDateStruct': {'date': '2024-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood flow changes in the upper extremity.', 'timeFrame': '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.', 'description': 'Changes in blood flow to the upper extremity in participants who have been experiencing TOS symptoms.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Blood Flow', 'Osteopathic Manipulation', 'Ultrasonography'], 'conditions': ['Thoracic Outlet Syndrome']}, 'referencesModule': {'references': [{'pmid': '24909503', 'type': 'BACKGROUND', 'citation': 'Chen H, Doornbos 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.'}, {'pmid': '37166516', 'type': 'BACKGROUND', 'citation': 'Cocco 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.'}, {'type': 'BACKGROUND', 'citation': 'Kimberly PE, Halma K. Outline of osteopathic manipulative procedures: the Kimberly manual 2006. Marceline (MO): Walsworth Publishing; 2008.'}, {'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': "Dalley AF 2nd, Agur AMR. Moore's clinically oriented anatomy. 9th ed. Philadelphia (PA); Wolters Kluwer; 2023."}, {'type': 'BACKGROUND', 'citation': 'Nicholas AS, Nocholas EA. Atlas of osteopathic techniques. 4th ed. Philadelphia (PA): Wolters Kluwer; 2023.'}, {'pmid': '27568153', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '15458598', 'type': 'BACKGROUND', 'citation': 'Huang JH, Zager EL. Thoracic outlet syndrome. Neurosurgery. 2004 Oct;55(4):897-902; discussion 902-3. doi: 10.1227/01.neu.0000137333.04342.4d.'}, {'pmid': '24603038', 'type': 'BACKGROUND', 'citation': 'Lapegue 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.'}, {'pmid': '25832605', 'type': 'BACKGROUND', 'citation': 'Moore R, Wei Lum Y. Venous thoracic outlet syndrome. Vasc Med. 2015 Apr;20(2):182-9. doi: 10.1177/1358863X14568704.'}, {'pmid': '630465', 'type': 'BACKGROUND', 'citation': 'Pisko-Dubienski ZA, Hollingsworth J. Clinical application of Doppler ultrasonography in the thoracic outlet syndrome. Can J Surg. 1978 Mar;21(2):145-7, 150.'}, {'pmid': '17928256', 'type': 'BACKGROUND', 'citation': 'Stapleton 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.'}, {'pmid': '21955534', 'type': 'BACKGROUND', 'citation': 'Sucher 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.'}, {'pmid': '28189360', 'type': 'BACKGROUND', 'citation': 'Vemuri 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.'}, {'pmid': '11444739', 'type': 'BACKGROUND', 'citation': 'Wadhwani 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.'}, {'pmid': '31423397', 'type': 'BACKGROUND', 'citation': 'Yuschak E, Haq F, Chase S. A Case of Venous Thoracic Outlet Syndrome: Primary Care Review of Physical Exam Provocative Tests and Osteopathic Manipulative Technique Considerations. Cureus. 2019 Jun 17;11(6):e4921. doi: 10.7759/cureus.4921.'}, {'pmid': '36018621', 'type': 'BACKGROUND', 'citation': 'Cavanna AC, Giovanis A, Daley A, Feminella R, Chipman R, Onyeukwu V. Thoracic outlet syndrome: a review for the primary care provider. J Osteopath Med. 2022 Aug 29;122(11):587-599. doi: 10.1515/jom-2021-0276. eCollection 2022 Nov 1.'}, {'pmid': '31037504', 'type': 'BACKGROUND', 'citation': 'Jones MR, Prabhakar A, Viswanath O, Urits I, Green JB, Kendrick JB, Brunk AJ, Eng MR, Orhurhu V, Cornett EM, Kaye AD. Thoracic Outlet Syndrome: A Comprehensive Review of Pathophysiology, Diagnosis, and Treatment. Pain Ther. 2019 Jun;8(1):5-18. doi: 10.1007/s40122-019-0124-2. Epub 2019 Apr 29.'}, {'type': 'BACKGROUND', 'citation': 'Kim M, Chi EH, Lee J, Ha I. The clinical observation of muscle energy techniques of ligamentous articular strain in 2 cases of cervical disc herniation with thoracic outlet syndrome. Int J of Osteo Med. 2015; 18: 63-70.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nOMT 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.\n\nMore 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.\n\nUS 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women 18-65 years of age\n* Experienced intermittent tingling and/or numbness in one or both hands that has occurred within two weeks of the start date of this study.\n\nExclusion Criteria:\n\n* Pregnant\n* Body mass index (BMI) over 30 kg/m2 (obese)\n* Prior surgery, broken bones, or known birth defects affecting the thoracic outlet, such as clavicular fracture or congenital first rib'}, 'identificationModule': {'nctId': 'NCT06273969', 'acronym': 'TOS', 'briefTitle': 'Ultrasonographic Evaluation of Osteopathic Manipulation for Thoracic Outlet Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'A.T. Still University of Health Sciences'}, 'officialTitle': 'Protocol Development for Ultrasonographic Evaluation of the Effect of Osteopathic Manipulative Techniques on Thoracic Outlet Syndrome', 'orgStudyIdInfo': {'id': 'PK20240105-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Osteopathic Manipulative Treatment', 'description': 'The OMT protocol is designed to target the somatic dysfunction associated with TOS.', 'interventionNames': ['Other: Osteopathic Manipulative Treatment (OMT)']}], 'interventions': [{'name': 'Osteopathic Manipulative Treatment (OMT)', 'type': 'OTHER', 'description': '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:\n\nDirect Thoracic Inlet Myofascial Release (TIMFR) - Reduce tension at the thoracic inlet fascia located between the thoracic outlet and the cervical spine.\n\nDirect Muscle Energy for the Scalene Muscles -Reduce tension within the scalene muscle group\n\nDirect Muscle Energy for the Pectoralis Muscles - Reduce tension within the pectoralis muscle group\n\nSupraclavicular Fascial Release - Reduce fascial tension within the supraclavicular fossa', 'armGroupLabels': ['Osteopathic Manipulative Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63548', 'city': 'Kirksville', 'state': 'Missouri', 'country': 'United States', 'facility': 'A.T. Still University', 'geoPoint': {'lat': 40.19475, 'lon': -92.58325}}], 'overallOfficials': [{'name': 'Peter Kondrashov, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'A.T. Still University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'A.T. Still University of Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}