NCT06642233

Mobility of the Cervical Spine in Patients With Unspecific Neck Pain

Relationships Among Cervical Functional Test in Patients With Unspecific Neck Pain: a Descriptive and Correlation Study

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Wroclaw University of Health and Sport Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Detailed description

The increasing number of people working for a long time in one body position or performing physical work causes an increasing incidence of unspecific neck pain. This translates into an increased need for examination and rehabilitation of these patients. The gold standard for evaluating and treating these patients has yet to be established and current methods are not complete. The complementary objectives of the researches will be to describe the craniovertebral angle, the range of motion of the cervical and upper cervical spine, deep flexor activation, disability, functional variables in the unspecific neck pain and the correlation of posture, function and cervical spine disability variables in the unspecific neck pain. The study participants will be women and men aged 18 to 75 suffering from unspecific neck pain. People who agree to participate in the study will receive information about the research project and its goals. Any interested person will have the opportunity to discuss any aspect of the research with the project leader. All participants are also reminded that their anonymity is guaranteed, that they can withdraw from the project at any time without giving any explanation and that the data obtained are for only research purposes. There will be no prior information about the division of participants into groups. Individuals who ultimately agree to participate in the study must sign an informed written consent. All measurements will be performed in one room, where constant environmental conditions will be maintained during the procedure, which will increase the reliability, accuracy and validity of the research. The doctoral student - researcher will be responsible for contacting and setting the dates and times of the meeting with patients, as well as for the entire administrative procedure, such as: information documents, explanations, obtaining informed written consent to participate in the project. The assessment procedure and measurements will be carried out by the doctoral student. Participants will be informed that they may not share information about the measurement results and the intervention received with any of the other project participants in order to maintain their blinding. The first condition for joining the study will be meeting the inclusion and exclusion criteria. Once the sample is selected, an initial assessment will be performed by collecting data on the patients history. Project participants will take part in one study. During the study, the participant will complete the given questionnaires, the body composition analysis and then manual tests will be performed. Cervical spine safety tests will be performed prior to manual testing. The approximate duration of the assessment session will be 90 minutes. The patient will be informed that the procedure must be painless at all times and only a feeling of tightness or stretching is acceptable (below 3 out of 10 on the VAS scale). The outline of the design study protocol is as follows: 1. Socio-demographic survey 2. VAS scale 3. The WHOQOL-BREF questionnaire 4. The IPAQ questionnaire 5. The Neck Disability Index questionnaire (NDI) 6. Body composition analysis using TANITA device 7. Cervical spine AROM 8. Sagittal plane UCS AROM 9. Flexion-Rotation Test 10. Sidebending-Rotation Test 11. Axial rotation test C0-C2 12. Tilting test C0-C1 and C2-C3 13. Craniocervical flexion test 14. Craniovertebral angle

Conditions

• Manual Therapy
• Cervical Spine
• Neck Pain

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	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.
DIAGNOSTIC_TEST	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.
DIAGNOSTIC_TEST	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).
DIAGNOSTIC_TEST	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.
DIAGNOSTIC_TEST	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.
DEVICE	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.
DIAGNOSTIC_TEST	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.
DIAGNOSTIC_TEST	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.
DIAGNOSTIC_TEST	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.
DIAGNOSTIC_TEST	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.
DIAGNOSTIC_TEST	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.
DIAGNOSTIC_TEST	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.
DIAGNOSTIC_TEST	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).
DIAGNOSTIC_TEST	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.

Timeline

• Start date: 2024-06-21
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2024-10-15
• Last updated: 2024-10-15

Locations

1 site across 1 country: Poland