Sponsor study identifier
observational
30
0 countries
N/A
Study Start
April 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
June 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 20, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Thoracic outlet syndrome (TOS) denotes the collection of symptoms which may arise from compression of the neurovascular structures in the region of the brachial plexus. TOS has historically been a clinical enigma, with lack of consensus regarding its diagnosis limiting the validity of any research into it. Literature and local audit both note significant patient morbidity and redundant use of secondary care clinics and investigations in sufferers. The last decade has seen the creation of a consortium of leaders in the field and development of the CORE-TOS diagnostic tool. This tool has 5 subsets of clinical diagnostic criteria (CDC). Positivity in 4 or more suggests a diagnosis of TOS. The current study seeks to specifically examine whether physiotherapy clinicians - both in primary and secondary care - can consistently identify cases of TOS using the CORE-TOS tool and refer them appropriately to an extended scope physiotherapist (ESP) specialising in the condition. Specific education will be provided to relevant physiotherapists who will be asked to note all relevant CDC in any suspected cases thereafter referred to the ESP in an out-patient physiotherapy department setting. These referrals will follow the standard local pathway to physiotherapy and no clinical testing manoeuvres out with the current scope of physiotherapy will be applied. The patients' case notes will thereafter be retrospectively examined, and the inter-rater reliability of the CDC recorded by the both the referring physiotherapist on their referral and the researcher at initial review. This will analysed using intraclass correlation coefficient, SEM and Bland and Altman's agreement tests, coupled with descriptive analysis.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 20, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 8, 2022
Actual (reported)February 23, 2022
Actual (reported)April 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
August 20, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
CORE-TOS clinical diagnostic criteria
Number of clinical diagnostic criteria (out of 5) found on clinical examination. This will range from 0 to 5, with a score of 4 or greater required to assume a diagnosis of thoracic outlet syndrome.
Through study completion, between April 2021 and April 2022
Collection of clinical findings from clinical examination, subdivided into 5 sub-categories. Positivity in 4 or 5 of these subcategories is considered diagnostic for thoracic outlet syndrome (TOS).
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
The study sample will be extracted from the population of patients referred to the target out-patient physiotherapy department in the normal course of events, with a complaint of neck and arm discomfort. They will be directed to the study based on the collection of clinical findings by the referrer.
Shrout PE, Fleiss JL. Intraclass correlations: uses in assessing rater reliability. Psychol Bull. 1979 Mar;86(2):420-8. doi: 10.1037//0033-2909.86.2.420.
Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986 Feb 8;1(8476):307-10.
Research methods for clinical therapists: applied project design and analysis Carolyn M Hicks Research methods for clinical therapists: applied project design and analysis Churchill LIvingstone 352 Fifth edition pound22.99 9780043074301 [Formula: see text]. Nurse Res. 2010 Oct 22;18(1):89. doi: 10.7748/nr.18.1.89.s3.
John A O'Toole, BSc (Hons)
Masters Student
First Submitted
February 8, 2022
First Posted
February 23, 2022
Study Start
April 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
June 1, 2022
Electromyography in Thoracic Outlet Syndrome
Contact the study team to confirm eligibility.
Koo TK, Li MY. A Guideline of Selecting and Reporting Intraclass Correlation Coefficients for Reliability Research. J Chiropr Med. 2016 Jun;15(2):155-63. doi: 10.1016/j.jcm.2016.02.012. Epub 2016 Mar 31.
Hallgren KA. Computing Inter-Rater Reliability for Observational Data: An Overview and Tutorial. Tutor Quant Methods Psychol. 2012;8(1):23-34. doi: 10.20982/tqmp.08.1.p023.
Bruton, A., Conway, J.H. and Holgate, S.T. (2000) Reliability: What Is It, and How Is It Measured? Physiotherapy, 86, 94-99.
Nunnally, J.C. and Bernstein, I.H. (1994) The Assessment of Reliability. Psychometric Theory, 3, 248-292.
Portney, L. G., & Watkins, M. P. (2009). Foundations of clinical research: applications to practice. Upper Saddle River: Pearson/Prentice Hall.
Rankin G, Stokes M. Reliability of assessment tools in rehabilitation: an illustration of appropriate statistical analyses. Clin Rehabil. 1998 Jun;12(3):187-99. doi: 10.1191/026921598672178340.
Atkinson G, Nevill AM. Statistical methods for assessing measurement error (reliability) in variables relevant to sports medicine. Sports Med. 1998 Oct;26(4):217-38. doi: 10.2165/00007256-199826040-00002.
Balderman J, Holzem K, Field BJ, Bottros MM, Abuirqeba AA, Vemuri C, Thompson RW. Associations between clinical diagnostic criteria and pretreatment patient-reported outcomes measures in a prospective observational cohort of patients with neurogenic thoracic outlet syndrome. J Vasc Surg. 2017 Aug;66(2):533-544.e2. doi: 10.1016/j.jvs.2017.03.419.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 20, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
February 23, 2022
Record last verified: 2022-02
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: