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An Investigation of the Cervical Region Biomechanics in Patients With Chronic Obstructive Pulmonary Disease

Kronik Obstruktif Akciğer Hastalığında Servikal bölge Biyomekaniği, Kas Performansı ve Solunum Kas Kuvvetinin İncelenmesi

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06246370
Enrollment
34
Registered
2024-02-07
Start date
2024-02-20
Completion date
2025-09-06
Last updated
2024-02-07

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

Conditions

Cervical Pain, Chronic Obstructive Pulmonary Disease, Cough, Postural; Defect

Brief summary

The aim of this study is to investigate cervical region biomechanics, muscle performance and respiratory muscle strength in patients with Chronic Obstructive Pulmonary Disease (COPD) compared to healthy subjects.

Detailed description

The secondary purposes are to investigate the correlation between cervical region biomechanics and posture, functional exercise capacity, depression &anxiety level,neck disability, cough severity. In accordance with this purposes, 17 patients with COPD who have Global Initiative for Chronic Obstruction Lung Disease (GOLD) stage 1-2-3-4, being clinically stable for 4 weeks and 17 healthy controls will be included ages\>40. Tests and questionnaires will be used in order to determine the severity of COPD and to evaluate posture. Photographical analysis in lateral and posterior views will be used for evaluation of cranioservical region static and dynamic biomechanics. To analyze of chest wall, radiographic evaluation will be performed. Goniometry will be used for evaluation dynamic craniocervical kinematic analysis. Cranioservical region muscle strength and endurance tests will be performed. Respiratory muscle strength tests and cough evaluation test will be performed. Neck disability index, cough evaluation test questionnare, beck depression and anxiety questionnares, Nordic Musculoskeletal questionnare will be used. 6 Minute Pegboard and Ring Test, 6 Minute Walk Test will be performed. According to the results to be obtained, relationship between cranioservical region biomechanics and posture will be investigated based on the severity of disease in patients with COPD. It will guide professional working in the field.

Interventions

None listed

Sponsors

Hacettepe University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* • Being diagnosed with stage 1-2-3-4 according to the Classification of Airflow Limitation in COPD (GOLD) system, * Being \>40 years old, * Being cognitively competent to understand and answer evaluation questions. * Being clinically stable for the last 4 weeks, * Being under control of accompanying comorbid conditions (such as hypertension, diabetes), * Volunteering to participate in the research.

Exclusion criteria

* • Having been hospitalized due to exacerbation in the last 3 months, * Having a musculoskeletal, neurological, rheumatological or oncological disease that affects the craniocervical & cervicothoracic joints and/or may prevent evaluation, * Having undergone any surgical intervention on the craniocervicofacial region and spine in the last six months, * Having lung malignancy, neoplasm, adenocarcinoma, * Being a lung cancer patient or having received cancer treatment (head and neck lung radiotherapy), having undergone pneumonectemia, lobectomy or resection surgery, * Being treated for anxiety and depression, * Having scoliosis, * Having a congenital anomaly of the craniocervicofacial region. * Having 3 out of 4 findings according to the diagnostic criteria for cervical radiculopathy, * Having thoracic outlet syndrome (TOS)

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of sagittal cobb angleday 1Cobb anle will measure from X-ray imagination between T2- T12 level.
Cranial rotation angleday 1Tragus- eye horizontal angle will measure from lateral cervical photographs.
evaluation of cervical region biomechanic (dynamic)day 1Investigation of the cervical region range of motions of cervical flexion, cervical extension, cervical lateral flexion, and cervical rotation range of motion.
cervical inclination angleday 1tragus eye and C7 level horizontal angle will measure from lateral cervical photographs.
cervical lateral flexion angleday 1the angle between pogonion-tragus and C7 level will measure from lateral cervical photographs.
Shoulder elevation/depression angleday 1the angle between acromion- C7 level and horizontal line will measure from lateral cervical photographs.
chest wall analysisday 1the distance between 3rd, 7th and 9th ribs and horizontal line will measure from X-Ray
rib angleday 1Sternum and 4th,5th, 6th rib will mark and the angle between these and maximum anteroposteror dimention of the thorax will measure from X-Ray.
diaphragma heightday 1the distance between T1- and L2 level will measure from X-Ray.

Secondary

MeasureTime frameDescription
evaluation of cervical radiculopathyday 11. Spurling test 2. cervical distraction test 3. cervical rotation test (if + spurling and cervical distraction test side is same with this test and is lower than 60 degree) 4. upper extremity stretching test If there are 3 positive answer to 4 tests, cervical radiculopathy existence will be detected.
investigation of neck disability severityday 1evaluation of neck disability level by neck disability index,10-point change should be used as the minimum clinically important difference for patients with upper extremity referred sypmtoms
investigation of the disease severityday 1evaluation of the disease severity with chronic obstructive pulmonary disease severity with Chronic Respiratory Questionnaire MCID( minimal clinically important difference) = a change of 0.5 per item A change in the score of 0.5 on the 7 point scale reflects a clinically significant small change A change of 1.0 reflects a moderate change A difference of 1.5 represents a large change
postural analysisday 1investigation of posture by photographic analysis in patients with COPD upward rotation/ anterior tilt/internal rotation of scapula, scapular elevation, and scapular abduction evaluations will measure from photographic analysis.
cough sufficiency in patients with COPDday 1evaluation of cough sufficiency with peak expiratory flow meter device, A peak expiratory flow of \< 80% predicted was the best cut-off to detect airflow limitation.
depression levelday 1investigation of depression level with Beck Depression Inventory (cut off point is 17 point) Conventional cutoffs are 0-9 for normal range, 10-18 for mild to moderate depression, 19-29 for moderate to severe depression, and 30-63 for severe depression.
investigation of the Pulmonary Functionday 1evaluation of pulmonary functions with Lung function test FEV %,FEV1 %, FVC %, FEV1/FVC % , FEF 25-75%, PEF %
respiratory muscle strengthday 1respiratory muscle strength by mouth pressure device, mean inspiratory pressure and mean expiratory pressure will be tested.
cervical region muscle strength and enduranceday 1investigation of cervical region muscle strength and endurance with stabilizer biofeedback pressure method
airway flow limitationday 1severity of disease by Global İnitiative for Chronic Obstructive Pulmonary Disease scale, GOLD 1: FEV1 (predicted%) ≥%80 GOLD 2: %50 ≤ FEV1 (predicted% ) \< %79 GOLD 3: %30 ≤ FEV1 (predicted%) \< %49 GOLD 4 : FEV1 (predicted%) \< %30
management of coughday 1cough severity will be tested by the Cough evaluation Test.(1-5 scaling of items, 5-25 score range) The minimal important difference was 2.
Upper Extremity Functional Capacityday 1evaluation of upper extremity functional capacity with 6-minute pegboard ring test
functional exercise capacityday 1functional exercise capacity by 6 minute walking test.
anxiety levelday 1investigation of anxiety level with the Beck Anxiety Questionnaire (A total score of 0-7 is considered minimal range, 8-15 is mild, 16-25 is moderate, and 26-63 is severe)
general musculoskeletal pain levelday 1general musculoskeletal pain level is evaluated by Nordic Musculoskeletal Questionnare, cut off point is 'one yes answer'

Countries

Turkey (Türkiye)

Contacts

Primary ContactAYNUR DEMIREL, PhD
aynur.demirel@hacettepe.edu.tr+9053123051576
Backup ContactAynur Demirel
aynur.demirel@hacettepe.edu.tr+9053123051576

Outcome results

None listed

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