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Dysfunctional Breathing in Individuals With Thoracic Outlet Syndrome

Investigation of the Properties of Dysfunctional Breathing in Individuals With Thoracic Outlet Syndrome

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06992752
Enrollment
54
Registered
2025-05-28
Start date
2025-02-02
Completion date
2025-10-02
Last updated
2025-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thoracic Outlet Syndrome

Keywords

Thoracic Outlet Syndrome, Dysfunctional Breathing

Brief summary

The aim of this observational study was to learn about the characteristics of dysfunctional breathing in individuals with thoracic outlet syndrome. The main question to be answered is: Is there a dysfunctional breathing pattern in individuals with Thoracic outlet syndrome? These features will be compared with a healthy control group to evaluate the association of Thoracic outlet syndrome with dysfunctional breathing

Interventions

None listed

Sponsors

Hacettepe University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* To agree to participate in the study, * To have been diagnosed with TOS by a thoracic surgeon, * To be between 18-65 years old, * Having pain for more than 6 months

Exclusion criteria

* Patients with a history of spinal or thoracic surgery for TOS or any other reason, * People with traumatic cervical injury, * Severely obese people (BMI \>40 kg/m2), * People with clinical abnormalities in the thoracic cage or vertebral column, * Persons with occupational industrial exposures, * Patients with severe comorbidities (neurological, neuromuscular, -cardiorespiratory, psychiatric and musculoskeletal) diabetes mellitus and/or malignancies

Design outcomes

Primary

MeasureTime frameDescription
Nijmegen QuestionnaireDay 1A cut-off score of ≥20 in Nijmegen will be used to define dysfunctional breathing. The minimum score is 0 and the maximum score is 60 points. Higher scores mean worse outcome.
End tidal CO2Day 1A standard value of \<35 mmHg will be used as the cut-off point for dysfunction
Manual Assessment of Respiratory Motion5 minutesThis technique is used to assess and measure the distribution of respiratory movement between the upper and lower parts of the rib cage and abdomen

Secondary

MeasureTime frameDescription
Forced Expiratory Flow 25-75% (FEF25-75)Day 1Forced Expiratory Flow 25-75% (FEF25-75%) will be assessed with a spirometer according to American Thoracic Society and European Respiratory Society criteria. The air flow rate (L/s) during the middle part of the exhalation (25%-75%) will be recorded.
Peak Expiratory Flow (PEF)Day 1Peak Expiratory Flow (PEF) will be assessed with a spirometer according to American Thoracic Society and European Respiratory Society criteria. The highest flow rate (L/s) achieved during a forceful exhalation will be recorded.
Breath Holding at Functional Residual Capasity5 minutesIf the duration is less than 25 seconds, it is considered as possible dysfunctional breathing
Breath Holding at Total Lung Capacity5 minutesIf the duration is less than 35 seconds, it is considered as possible dysfunctional breathing
Pain severity5 minutesVisual analog scale (VAS) will be used in the assessment.Individuals' pain at rest, during activity and at night will be assessed on a scale of 0-10.Minimum score is 0 and maximum score is 10 Higher scores mean a worse outcome.
Forced Expiratory Volume in 1 second (FEV1)Day 1Forced Expiratory Volume in 1 second (FEV1) will be done with a spirometer according to the American Thoracic Society and European Respiratory Society criteria. The amount of air (L) a person can forcefully expel in the first second of a breath will be recorded
Pain tolerance10 minutesthe maximum tolerated pressure value will be recorded in the assessment of pain tolerance
Beck Anxiety Scale5 minutesThe scale has 21 questions. The questions will be answered by selecting one of four options: none, mild, moderate and severe. 8-15 points will be categorized as mild anxiety symptoms, 16-25 points as moderate anxiety symptoms, 26 - 63 points as severe anxiety symptoms. the maximum score of the scale is 63
EQ-5D-5L General Quality of Life Scale5 minutesThe scale has two parts. The first section has five sub-scales: movement, self-care, usual activities, pain/discomfort and anxiety/depression. The answers given in each section have 5 options; no problem, mild problem, moderate problem, severe problem and extreme problem. In the second section, individuals give a value between 0 and 100 about their current health status.
Type D Personality Scale5 minutesIt consists of a total of 14 items and two subscales measuring negative affectivity and social inhibition. Each item is scored on a 0-4 scale. The cut-off point of the two subscales is ≥ 10.
Pain treshold10 minutesFor the assessment of pain threshold, the minimum pressure value that causes pain or discomfort will be recorded
Forced Vital Capacity (FVC)Day 1Forced Vital Capacity (FVC) will be done with a spirometer according to the American Thoracic Society and European Respiratory Society criteria. The total amount of air (L) that can be forced out after taking a deep breath will be recorded. Measures lung capacity.
FEV1/FVC RatioDay 1The percentage of the ratio of FEV1 to FVC will be calculated and recorded

Countries

Turkey (Türkiye)

Contacts

Primary ContactMelda Sağlam, Professor
msaglam@hacettepe.edu.tr+903123052525

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026