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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06246370
• Other study ID #: GO 23/616
• Status: Not yet recruiting
• Start date: February 20, 2024
• Est. completion date: September 6, 2025

Study information

• Verified date: January 2024
• Source: Hacettepe University
• Contact: AYNUR DEMIREL, PhD
• Phone: +9053123051576
• Email: aynur.demirel[@]hacettepe.edu.tr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 34
• Est. completion date: September 6, 2025
• Est. primary completion date: September 6, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cervical Pain
• Chronic Obstructive Pulmonary Disease
• Cough
• Lung Diseases
• Lung Diseases, Obstructive
• Neck Pain
• Postural; Defect
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
Turkey	Hacettepe University, Health Sciences Faculty	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of sagittal cobb angle	Cobb anle will measure from X-ray imagination between T2- T12 level.	day 1
Primary	Cranial rotation angle	Tragus- eye horizontal angle will measure from lateral cervical photographs.	day 1
Primary	evaluation of cervical region biomechanic (dynamic)	Investigation of the cervical region range of motions of cervical flexion, cervical extension, cervical lateral flexion, and cervical rotation range of motion.	day 1
Primary	cervical inclination angle	tragus eye and C7 level horizontal angle will measure from lateral cervical photographs.	day 1
Primary	cervical lateral flexion angle	the angle between pogonion-tragus and C7 level will measure from lateral cervical photographs.	day 1
Primary	Shoulder elevation/depression angle	the angle between acromion- C7 level and horizontal line will measure from lateral cervical photographs.	day 1
Primary	chest wall analysis	the distance between 3rd, 7th and 9th ribs and horizontal line will measure from X-Ray	day 1
Primary	rib angle	Sternum and 4th,5th, 6th rib will mark and the angle between these and maximum anteroposteror dimention of the thorax will measure from X-Ray.	day 1
Primary	diaphragma height	the distance between T1- and L2 level will measure from X-Ray.	day 1
Secondary	postural analysis	investigation 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.	day 1
Secondary	respiratory muscle strength	respiratory muscle strength by mouth pressure device, mean inspiratory pressure and mean expiratory pressure will be tested.	day 1
Secondary	cervical region muscle strength and endurance	investigation of cervical region muscle strength and endurance with stabilizer biofeedback pressure method	day 1
Secondary	airway flow limitation	severity of disease by Global Initiative 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	day 1
Secondary	management of cough	cough severity will be tested by the Cough evaluation Test.(1-5 scaling of items, 5-25 score range) The minimal important difference was 2.	day 1
Secondary	Upper Extremity Functional Capacity	evaluation of upper extremity functional capacity with 6-minute pegboard ring test	day 1
Secondary	functional exercise capacity	functional exercise capacity by 6 minute walking test.	day 1
Secondary	anxiety level	investigation 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)	day 1
Secondary	general musculoskeletal pain level	general musculoskeletal pain level is evaluated by Nordic Musculoskeletal Questionnare, cut off point is 'one yes answer'	day 1
Secondary	evaluation of cervical radiculopathy	Spurling test; cervical distraction test; cervical rotation test (if + spurling and cervical distraction test side is same with this test and is lower than 60 degree); upper extremity stretching test; If there are 3 positive answer to 4 tests, cervical radiculopathy existence will be detected.	day 1
Secondary	investigation of neck disability severity	evaluation 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	day 1
Secondary	investigation of the disease severity	evaluation 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	day 1
Secondary	investigation of the Pulmonary Function	evaluation of pulmonary functions with Lung function test FEV %,FEV1 %, FVC %, FEV1/FVC % , FEF 25-75%, PEF %	day 1
Secondary	cough sufficiency in patients with COPD	evaluation 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.	day 1
Secondary	depression level	investigation 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.	day 1