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NCT Number: NCT06992752

Dysfunctional Breathing in Individuals With Thoracic Outlet Syndrome

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Nijmegen Questionnaire

    Time frame: Day 1

    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.

  2. End tidal CO2

    Time frame: Day 1

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

  3. Manual Assessment of Respiratory Motion

    Time frame: 5 minutes

    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

Secondary outcomes

  1. Forced Vital Capacity (FVC)

    Time frame: Day 1

    Forced 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.

  2. Forced Expiratory Volume in 1 second (FEV1)

    Time frame: Day 1

    Forced 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

  3. FEV1/FVC Ratio

    Time frame: Day 1

    The percentage of the ratio of FEV1 to FVC will be calculated and recorded

  4. Forced Expiratory Flow 25-75% (FEF25-75)

    Time frame: Day 1

    Forced 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.

  5. Peak Expiratory Flow (PEF)

    Time frame: Day 1

    Peak 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.

  6. Breath Holding at Functional Residual Capasity

    Time frame: 5 minutes

    If the duration is less than 25 seconds, it is considered as possible dysfunctional breathing

  7. Breath Holding at Total Lung Capacity

    Time frame: 5 minutes

    If the duration is less than 35 seconds, it is considered as possible dysfunctional breathing

  8. Pain severity

    Time frame: 5 minutes

    Visual 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.

  9. Pain treshold

    Time frame: 10 minutes

    For the assessment of pain threshold, the minimum pressure value that causes pain or discomfort will be recorded

  10. Pain tolerance

    Time frame: 10 minutes

    the maximum tolerated pressure value will be recorded in the assessment of pain tolerance

  11. Beck Anxiety Scale

    Time frame: 5 minutes

    The 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

  12. EQ-5D-5L General Quality of Life Scale

    Time frame: 5 minutes

    The 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.

  13. Type D Personality Scale

    Time frame: 5 minutes

    It 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Melda Sağlam, Professor

CONTACT

[email protected]

+903123052525 ext. 146

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 28, 2025
Registry last updated
May 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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