Mobility of the Cervical Spine in Patients With Unspecific Neck Pain
- Conditions
- Manual TherapyCervical SpineNeck Pain
- Registration Number
- NCT06642233
- Lead Sponsor
- Wroclaw University of Health and Sport Sciences
- Brief 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
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cervical Range of Motion 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 Outcome Measures
Name Time Method Pain intensity 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.
Quality of Life level 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.
Degree of Functional Disability 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.
Physical activity level 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).
Craniovertebral angle 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).
Activation of the deep flexor muscles 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.
Body composition analysis 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.
Trial Locations
- Locations (1)
Wroclaw University of Health and Sport Sciences
🇵🇱Wrocław, Dolnośląskie, Poland