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Clinical Trials in Poland / NCT06642233
Active, not recruiting Observational

Mobility of the Cervical Spine in Patients With Unspecific Neck Pain

NCT06642233 · tracked via the Priya Life Science Poland tracker
Phase
Observational
Started
2024-06-21
Last updated
2024-10-15

Condition(s) studied

Manual TherapyCervical SpineNeck Pain

Investigational drug(s) / intervention(s)

Socio-demographic surveyVisual Analogue ScaleThe World Health Organization Quality-of-Life Scale-BREF questionnaireThe International Physical Activity QuestionnaireThe Neck Disability Index questionnaireBody composition analysis using TANITA deviceCervical spine AROM (Active range of motion)Sagittal plane UCS AROM (Upper cervical spine active range of motion)Flexion-Rotation TestSidebending-Rotation TestAxial rotation test C0-C2Tilting test C0-C1 and C2-C3Craniocervical flexion testCraniovertebral angle

Socio-demographic survey: Socio-demographic survey includes: age, sex, time of symptoms, work activity, hours of work activity, work position, activities with loads, physical activity, household chores, missing teeth, dental splints, dentures, smoking, alcohol consumption, whether they can reproduce their symptoms, hours during which they perform focal distance tasks, whether they have visual problems, whether they take painkillers or anti-inflammatory drugs, presence of headaches and their frequency), whether you can reproduce your symptoms, hours during which you perform tasks at focal distance, whether you have visual problems, whether you take analgesics or anti-inflammatory drugs, presence and frequency of headaches.

Visual Analogue Scale: VAS scale - The subject must indicate with a horizontal line their perception of pain on a scale (not numbered) of 100 millimetres, with 0 being the absence of pain and 100 the worst pain imaginable. The patient will complete the VAS scale, responding to the average, maximum and minimum pain experienced throughout its duration.

The World Health Organization Quality-of-Life Scale-BREF questionnaire: The WHOQOL-BREF questionnaire is used to assess domains quality of life: physical, mental, social functioning and functioning in the environment. Responses are on a 5-point scale (score range 1-5). In each field you can get maximum 20 points. The results of individual areas are positive (the higher the number of points, the higher the quality of life).

The International Physical Activity Questionnaire: The International Physical Activity Questionnaire (IPAQ) is a self-reported questionnaire for assessing physical activity and sedentary behavior for adults aged 15-69 years, across a range of socio-economic settings.

The Neck Disability Index questionnaire: The NDI evaluates the effect of neck pain on activities of daily living and social relationships. It consists of 10 items with 6 response options that are scored from 0 to 5 points each for a total possible score of 50. The classification of disability is based on the total score obtained, with higher number indicating greater disability.

Body composition analysis using TANITA device: TANITA device - body composition analyzer, the proportion of muscle mass and fat in the upper limbs * Body height will be determined using a SECA 217 stadimeter. * General and segmental body composition using the eight-electrode body composition analyzer by TANITA.

Cervical spine AROM (Active range of motion): Measurement of cervical spine AROM can be performed using the CROM system (Performance Attainment Associates, Roseville, MN, USA). Flexion, extension, side bending to the right and left, and rotation to the right and left of the cervical spine are examined. The CROM measuring equipment consists of a helmet-shaped structure with the shape of glasses. These glasses adjust to the nasal septum thanks to the velcro on the back to fit them on the head. Three inclinometers for measuring on 3 cardinal planes were placed in the plastic construction.

Sagittal plane UCS AROM (Upper cervical spine active range of motion): Measurement of sagittal plane UCS AROM can be performed using the CROM system. Flexion and extension of the upper cervical spine are examined.

Flexion-Rotation Test: The flexion-rotation test can be performed using the CROM system. Rotation of the upper cervical spine is tested while the cervical spine is flexed.

Sidebending-Rotation Test: The sidebending-rotation test can be performed using the CROM system. Rotation of the upper cervical spine is tested while the cervical spine is in a lateral tilt.

Axial rotation test C0-C2: The Axial rotation test C0-C2 can be performed using the CROM system. Rotation of the C0-C2 is examined.

Tilting test C0-C1 and C2-C3: The Tilting test C0-C1 and C2-C3 can be performed using a goniometer. Lateral tilt of the C0-C1 and C2-C3 are examined.

Craniocervical flexion test: The test measures the level of activation of the deep neck flexors using a pressure biofeedback device, an air-filled manual pressure cuff (Stabilizer TM, Chattanooga Group, INC., USA).

Craniovertebral angle: The test measure the craniovertebral angle using a telephone placed on a tripod and a computer program. The CVA measurement is defined as the angle a horizontal line passing the neural spine of C7 in relation to the line connecting the tragus and the neural spine of C7.

Study summary

The goal of this clinical trials is to describe and correlate the posture, function and disability of the cervical spine in patients with unspecific neck pain. The research hypothesis is: In patients with unspecific neck pain, there is a significant correlation between posture, function and disability of the cervical spine. Participants will take part in functional tests and complete surveys and questionnaires.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
Accepted
Inclusion Criteria: * age 18-75 years * medical diagnosis of non-specific pain in the cervical spine (M54.2 - neck pain) - acute and chronic pain, regardless of when it began * negative result of cervical spine safety tests * obtaining written consent to conduct research Exclusion Criteria: * pregnancy * pacemaker * active cancer * no consent to conduct research * difficulty communicating * the presence of a metal plate in the head and metal screws in the body * positive cervical spine safety test * condition after operations in the area of the cervical spine * condition after fractures in the cervical spine * vascular abnormalities and pathologies resulting in symptoms of vertebrobasilar insufficiency (carotid artery occlusion or dissection, vertebral artery insufficiency, emboli) * contraindications to manual therapy or exercise * has participated in a cervical spine exercise or manual therapy program in the last three months * present clear signs of having suffered a significant whiplash injury * inability to maintain a supine position * no possibility to perform a flexion-rotation test

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Wroclaw University of Health and Sport Sciences Wroclaw Lower Silesian Voivodeship

More Wroclaw University of Health and Sport Sciences trials in Poland

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06642233 on ClinicalTrials.gov ↗ ← All trials in Poland