Clinical trial NCT06642233: Mobility of the Cervical Spine in Patients With Unspecific Neck Pain
Official title: Relationships Among Cervical Functional Test in Patients With Unspecific Neck Pain: a Descriptive and Correlation Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Manual Therapy
Cervical Spine
Neck Pain
Keywords: manual therapy
cervical spine
neck pain
unspecific neck pain
body composition
functional neck tests
craniovertebral angle
CROM
Lead sponsor: Wroclaw University of Health and Sport Sciences
Sponsor class: OTHER
Collaborators: name: Universidad de Zaragoza
First posted: 2024-10-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients applying for individual therapy at the private manual medicine rehabilitation center (Łubinowa street 12/4, 52-210 Wrocław - Poland) and meeting the conditions for inclusion in the study group.

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

Eligibility criteria: 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 outcomes:
measure: Cervical Range of Motion
timeFrame: Baseline
Secondary outcomes:
measure: Pain intensity
timeFrame: Baseline
measure: Quality of Life level
timeFrame: Baseline
measure: Degree of Functional Disability
timeFrame: Baseline
measure: Physical activity level
timeFrame: Baseline
measure: Craniovertebral angle
timeFrame: Baseline
measure: Activation of the deep flexor muscles
timeFrame: Baseline
measure: Body composition analysis
timeFrame: Baseline
Other outcomes:
Locations:
city: Wrocław
country: Poland
facility: Wroclaw University of Health and Sport Sciences
state: Dolnośląskie
Study officials:
affiliation: Wroclaw University of Health and Sport Sciences
name: Katarzyna Wojnicz, Master
role: PRINCIPAL_INVESTIGATOR
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