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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Obstructive Pulmonary Disease; Cough; Cervical Pain; Postural; Defect

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.

• Study Type: Observational
• Enrollment (Estimated): 34

Contacts and Locations

• Study Contact: Name: AYNUR DEMIREL, PhD; Phone Number: 178 +9053123051576; Email: aynur.demirel@hacettepe.edu.tr
• Study Contact Backup: Name: Aynur Demirel; Phone Number: 178 +9053123051576; Email: aynur.demirel@hacettepe.edu.tr

Study Locations

• Turkey
  • Ankara, Turkey, 06100
    • Hacettepe University, Health Sciences Faculty
    • Contact: Aynur demirel, PhD; Phone Number: 168 +903052525; Email: aynur.demirel@hacettepe.edu.tr
    • Sub-Investigator: irem seleoglu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients referred by the department of chest diseases of Hacettepe university will be taken

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
COPD group; patients with COPD aged 40 years and above.
control group; aged matced healty patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of sagittal cobb angle	Cobb anle will measure from X-ray imagination between T2- T12 level.	day 1
Cranial rotation angle	Tragus- eye horizontal angle will measure from lateral cervical photographs.	day 1
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
cervical inclination angle	tragus eye and C7 level horizontal angle will measure from lateral cervical photographs.	day 1
cervical lateral flexion angle	the angle between pogonion-tragus and C7 level will measure from lateral cervical photographs.	day 1
Shoulder elevation/depression angle	the angle between acromion- C7 level and horizontal line will measure from lateral cervical photographs.	day 1
chest wall analysis	the distance between 3rd, 7th and 9th ribs and horizontal line will measure from X-Ray	day 1
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
diaphragma height	the distance between T1- and L2 level will measure from X-Ray.	day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
respiratory muscle strength	respiratory muscle strength by mouth pressure device, mean inspiratory pressure and mean expiratory pressure will be tested.	day 1
cervical region muscle strength and endurance	investigation of cervical region muscle strength and endurance with stabilizer biofeedback pressure method	day 1
airway flow limitation	severity 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	day 1
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
Upper Extremity Functional Capacity	evaluation of upper extremity functional capacity with 6-minute pegboard ring test	day 1
functional exercise capacity	functional exercise capacity by 6 minute walking test.	day 1
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
general musculoskeletal pain level	general musculoskeletal pain level is evaluated by Nordic Musculoskeletal Questionnare, cut off point is 'one yes answer'	day 1
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
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
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
investigation of the Pulmonary Function	evaluation of pulmonary functions with Lung function test FEV %,FEV1 %, FVC %, FEV1/FVC % , FEF 25-75%, PEF %	day 1
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
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

Collaborators and Investigators

• Sponsor: Hacettepe University
• Investigators: Principal Investigator: Aynur Demirel, Hacettepe University

Study record dates

Study Major Dates

• Study Start (Estimated): February 20, 2024
• Primary Completion (Estimated): September 6, 2024
• Study Completion (Estimated): September 6, 2025

Study Registration Dates

• First Submitted: October 11, 2023
• First Submitted That Met QC Criteria: January 30, 2024
• First Posted (Actual): February 7, 2024

Study Record Updates

• Last Update Posted (Actual): February 7, 2024
• Last Update Submitted That Met QC Criteria: January 30, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Pain; Neurologic Manifestations; Disease Attributes; Chronic Disease; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Neck Pain
• Other Study ID Numbers: GO 23/616

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No