Inter-rater Reliability of Diagnosing Thoracic Outlet Syndrome by Physiotherapists

NCT05252104 | Unknown

• 1 other identifier: Physio/IRR/TOS_20211210_v1.0
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Thoracic Outlet Syndrome

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

CORE-TOS diagnostic tool DIAGNOSTIC_TEST

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).

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• Individuals initially reviewed by a physiotherapist (rater 1).
• Individuals willing to attend for physiotherapy intervention.
• Minimum 12 weeks of symptoms of neck and upper limb pain and/or paraesthesia.
• Minimum 4/5 score on the CORE-TOS tool.

You may not qualify if:

• Previous central neurologic injury with persisting neural deficit in the upper limb
• Known history of peripheral neuropathy
• Unstable angina
• Upper limb allodynia or persistent pain sensitization
• Systemic Inflammatory conditions
• Those unwilling to attend for face to face consultation

Sponsors & Collaborators

• Queen Margaret University: lead

Related Publications (11)

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  PMID: 28735950 RESULT

MeSH Terms

Conditions

Thoracic Outlet Syndrome

Condition Hierarchy (Ancestors)

Nerve Compression Syndromes; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• John A O'Toole, BSc (Hons)

  Masters Student

  PRINCIPAL INVESTIGATOR

Central Study Contacts

John A O'Toole, BSc (Hons)

CONTACT

07958584097; 95278262@qmu.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Extended Scope Physiotherapy Practitioner

Study Record Dates

• First Submitted: February 8, 2022
• First Posted: February 23, 2022
• Study Start: April 1, 2022
• Primary Completion: June 1, 2022
• Study Completion: August 20, 2022
• Last Updated: February 23, 2022

Record last verified: 2022-02