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NCT Number: NCT06642233

Mobility of the Cervical Spine in Patients With Unspecific Neck Pain

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.

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Key information

Conditions

Manual Therapy Cervical Spine Neck Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Wroclaw University of Health and Sport Sciences

Wroclaw, Lower Silesian Voivodeship, 51-612, Poland

About this study

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:

  • Socio-demographic survey
  • VAS scale
  • The WHOQOL-BREF questionnaire
  • The IPAQ questionnaire
  • The Neck Disability Index questionnaire (NDI)
  • Body composition analysis using TANITA device
  • Cervical spine AROM
  • Sagittal plane UCS AROM
  • Flexion-Rotation Test
  • Sidebending-Rotation Test
  • Axial rotation test C0-C2
  • Tilting test C0-C1 and C2-C3
  • Craniocervical flexion test
  • Craniovertebral angle

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Socio-demographic survey

Diagnostic Test

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

Diagnostic Test

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

Diagnostic Test

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

Diagnostic Test

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

Diagnostic Test

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

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)

Diagnostic Test

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)

Diagnostic Test

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

Diagnostic 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

Diagnostic 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

Diagnostic Test

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

Diagnostic Test

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

Diagnostic 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

Diagnostic Test

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.

Primary outcomes

  1. Cervical Range of Motion

    Time frame: Baseline

    The CROM (Performance Attainment Associates, Roseville, MN, USA) is a device used to measure degrees of range of motion (ROM) in the cervical spine. 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. The range of flexion, extension, lateral bending, and rotation will be measured in degrees.

Secondary outcomes

  1. Pain intensity

    Time frame: Baseline

    The Visual Analog Scale (VAS) consists of a visual graduated scale from 0 to 10 cm, where 0 represents the absence of pain and 10 represents very intense pain, used to measure the pain experienced by the patient. The participant will complete the VAS scale, responding to the average, maximum and minimum pain experienced throughout its duration.

  2. Quality of Life level

    Time frame: Baseline

    To assess the quality of life of the participants, the WHOQOL-BREF will be utilized, an abbreviated instrument developed by the World Health Organization. This questionnaire will consist of 26 items distributed across four main domains: Physical, Psychological, Social Relationships, and Environment. Each item will be rated on a 5-point Likert scale, ranging from 1 ("not at all") to 5 ("extremely"). The scores for each domain will be calculated from the averages of the corresponding item responses, multiplied by 4 to transform the results into a scale of 0 to 100. Higher scores will indicate a better perception of quality of life in the specific domain.

  3. Degree of Functional Disability

    Time frame: Baseline

    The Neck Disability Index (NDI) questionnaire, which assesses the degree of functional disability of the cervical region, is a self-administered questionnaire consisting of 10 sessions with 6 responses, reflecting 6 stages of functional disability, with scores ranging from 0 to 5, where 0 represents the lowest and 5 represents the highest level of disability.

  4. Physical activity level

    Time frame: Baseline

    Measured using the short version of the International Physical Activity Questionnaire (IPAQ). Questionnaire contains 7 questions about all types of physical activity related to everyday life, work and leisure. Results are reported in categories depending on the variable 'MET minutes a week'. MET minutes represent the amount of energy expended carrying out physical activity. High physical activity (one hour of more of physical activity per day), moderate physical activity (half an hour of physical activity per day) or low physical activity (not meeting any of the criteria for either moderate or high levels of physical activity).

  5. Craniovertebral angle

    Time frame: Baseline

    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. Two markers are placed on the ground, 1.5 m apart, in which there is a camera or smartphone and the subject. Reference markers are placed on the C7 spinous process and the ear swallow of the examined person, which are identified by palpation. The subject is placed on a mark on the floor, barefoot and standing, facing the evaluator. The researcher then takes the photo. To measure the craniovertebral angle, a horizontal line is drawn starting from the spinous process of the seventh cervical vertebra using the angular dimension of the computer program. Then, an oblique line is drawn through the tragus of the ear to the spinous process of the seventh cervical vertebra. The craniovertebral angle is measured and will form where these 2 lines meet (spinous process of the 7th cervical vertebra).

  6. Activation of the deep flexor muscles

    Time frame: Baseline

    The Stabilizer Pressure Biofeedback Unit (Chattanooga, TN, USA) is used for measurement. Activation and resistance of the deep cervical flexors are assessed in five progressive pressure increases from 2 mmHg to a maximum of 30 mmHg. When the patient reaches a level three times, they move on to the next level.

  7. Body composition analysis

    Time frame: Baseline

    Body mass (Body composition analyzer BC 418 MA by Tanita), body height (height gauge SECA 217), based on them, determination of the BMI index and BMI percentile using percentile grids developed based on the OLAF program. Analysis of general and segmental parameters:

    • FatP - body fat mass in %,
    • FatM - body fat mass in kg,
    • FFM - body fat-free mass,
    • TBW - body water quantity in kg and %.
    • FFF index - based on the values of body fat and fat-free tissue, the general and segmental fat-free index is calculated.

Sponsors and collaborators

Lead sponsor

Wroclaw University of Health and Sport Sciences

Other

Collaborators

  • Universidad de Zaragoza

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Oct 15, 2024
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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