Dysfunctional Breathing in Individuals With Thoracic Outlet Syndrome

NCT06992752 | Recruiting

• 1 other identifier: SBA-24/775
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 1

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

Conditions

Thoracic Outlet Syndrome

Keywords

Thoracic Outlet Syndrome; Dysfunctional Breathing

Outcome Measures

Primary Outcomes (3)

• Nijmegen Questionnaire

  A 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.

  Day 1

• End tidal CO2

  A standard value of \<35 mmHg will be used as the cut-off point for dysfunction

  Day 1

• Manual Assessment of Respiratory Motion

  This technique is used to assess and measure the distribution of respiratory movement between the upper and lower parts of the rib cage and abdomen

  5 minutes

Secondary Outcomes (13)

• Forced Vital Capacity (FVC)

  Day 1

• Forced Expiratory Volume in 1 second (FEV1)

  Day 1

• FEV1/FVC Ratio

  Day 1

• Forced Expiratory Flow 25-75% (FEF25-75)

  Day 1

• Peak Expiratory Flow (PEF)

  Day 1

Study Arms (2)

Thoracic Outlet Syndrome

Thoracic Outlet Syndrome

Healthy control

Healthy control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, Altındağ, 06100, Turkey (Türkiye)

RECRUITING

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

• Melda Sağlam, Professor

  Hacettepe University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melda Sağlam, Professor

CONTACT

+903123052525; msaglam@hacettepe.edu.tr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: May 28, 2025
• Study Start: February 2, 2025
• Primary Completion: September 2, 2025
• Study Completion: October 2, 2025
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)