An observational study in Thoracic Outlet Syndrome, sponsored by Hacettepe University. Recruiting at 1 site in Turkey. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-28.
Sponsored by Hacettepe University · Observational
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
33 studies on the registry are indexed under Thoracic Outlet Syndrome; 11 are open to participants now.
This study's planned enrollment of 54 is below the median of 84 across 16 observational studies indexed under Thoracic Outlet Syndrome.
Browse Thoracic Outlet Syndrome studies →Hacettepe University is the lead sponsor of 1,007 studies on the registry; 214 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Thoracic Outlet Syndrome
Healthy control
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.
Time frame: Day 1
End tidal CO2
A standard value of \<35 mmHg will be used as the cut-off point for dysfunction
Time frame: 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
Time frame: 5 minutes
Forced Vital Capacity (FVC)
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.
Time frame: Day 1
Forced Expiratory Volume in 1 second (FEV1)
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
Time frame: Day 1
FEV1/FVC Ratio
The percentage of the ratio of FEV1 to FVC will be calculated and recorded
Time frame: Day 1
Forced Expiratory Flow 25-75% (FEF25-75)
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.
Time frame: Day 1
Peak Expiratory Flow (PEF)
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.
Time frame: Day 1
Breath Holding at Functional Residual Capasity
If the duration is less than 25 seconds, it is considered as possible dysfunctional breathing
Time frame: 5 minutes
Breath Holding at Total Lung Capacity
If the duration is less than 35 seconds, it is considered as possible dysfunctional breathing
Time frame: 5 minutes
Pain severity
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.
Time frame: 5 minutes
Pain treshold
For the assessment of pain threshold, the minimum pressure value that causes pain or discomfort will be recorded
Time frame: 10 minutes
Pain tolerance
the maximum tolerated pressure value will be recorded in the assessment of pain tolerance
Time frame: 10 minutes
Beck Anxiety Scale
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
Time frame: 5 minutes
EQ-5D-5L General Quality of Life Scale
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.
Time frame: 5 minutes
Type D Personality Scale
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.
Time frame: 5 minutes
Plan to share: No — for patient data privacy
No publications or documents are linked to this record.
Started Feb 2025 (actual). Primary completion is estimated for Sep 2025, 7 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.