Clinical trial NCT06992752: Dysfunctional Breathing in Individuals With Thoracic Outlet Syndrome
Official title: Investigation of the Properties of Dysfunctional Breathing in Individuals With Thoracic Outlet Syndrome
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Thoracic Outlet Syndrome
Keywords: Thoracic Outlet Syndrome
Dysfunctional Breathing
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2025-05-28
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In the study, adult patients aged between 18-65 years who were diagnosed with TOS by a thoracic surgeon at the Cardiopulmonary Rehabilitation Unit of the Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Hacettepe University, and who had pain complaints for more than 6 months without surgery will be evaluated. Control cases planned to be included in the study to compare with the results of the patients will be formed by using the snowball method from the immediate environment.

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


Eligibility criteria: 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

Primary outcomes:
measure: Nijmegen Questionnaire
timeFrame: Day 1
measure: End tidal CO2
timeFrame: Day 1
measure: Manual Assessment of Respiratory Motion
timeFrame: 5 minutes
Secondary outcomes:
measure: Forced Vital Capacity (FVC)
timeFrame: Day 1
measure: Forced Expiratory Volume in 1 second (FEV1)
timeFrame: Day 1
measure: FEV1/FVC Ratio
timeFrame: Day 1
measure: Forced Expiratory Flow 25-75% (FEF25-75)
timeFrame: Day 1
measure: Peak Expiratory Flow (PEF)
timeFrame: Day 1
measure: Breath Holding at Functional Residual Capasity
timeFrame: 5 minutes
measure: Breath Holding at Total Lung Capacity
timeFrame: 5 minutes
measure: Pain severity
timeFrame: 5 minutes
measure: Pain treshold
timeFrame: 10 minutes
measure: Pain tolerance
timeFrame: 10 minutes
measure: Beck Anxiety Scale
timeFrame: 5 minutes
measure: EQ-5D-5L General Quality of Life Scale
timeFrame: 5 minutes
measure: Type D Personality Scale
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
state: Altındağ
Study officials:
affiliation: Hacettepe University
name: Melda Sağlam, Professor
role: PRINCIPAL_INVESTIGATOR
References: