Manual TherapyNCT06642233
Mobility of the Cervical Spine in Patients With Unspecific Neck Pain
An observational study of Manual Therapy and Cervical Spine, run by Wroclaw University of Health and Sport Sciences at 1 site in Poland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Manual Therapy, Cervical Spine, Neck Pain
- What is being tested?
- Socio-demographic survey, Visual Analogue Scale and The World Health Organization Quality-of-Life Scale-BREF questionnaire
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- 21 Jun 2024to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Poland1 site
Wroclaw University of Health and Sport Sciences
Wroclaw, Lower Silesian Voivodeship, 51-612
About this study
Official title: Relationships Among Cervical Functional Test in Patients With Unspecific Neck Pain: a Descriptive and Correlation Study
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.
Read the 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:
- 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
- Conditions
- Manual Therapy, Cervical Spine, Neck Pain
- Being tested
- Socio-demographic survey, Visual Analogue Scale, The World Health Organization Quality-of-Life Scale-BREF questionnaire, The International Physical Activity Questionnaire, The Neck Disability Index questionnaire
- Keywords
- manual therapy, cervical spine, neck pain, unspecific neck pain, body composition, functional neck tests, craniovertebral angle, CROM
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Socio-demographic surveyDiagnostic 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 ScaleDiagnostic 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 questionnaireDiagnostic 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 QuestionnaireDiagnostic 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 questionnaireDiagnostic 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 deviceDevice
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 TestDiagnostic 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 TestDiagnostic 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-C2Diagnostic 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-C3Diagnostic 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 testDiagnostic 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 angleDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Women and men aged 18-75 | People with a medical diagnosis of unspecific pain in the cervical spine - acute and chronic pain, regardless of when it began. Receives: Diagnostic Test: Socio-demographic survey; Diagnostic Test: Visual Analogue Scale; Diagnostic Test: The World Health Organization Quality-of-Life Scale-BREF questionnaire; Diagnostic Test: The International Physical Activity Questionnaire; Diagnostic Test: The Neck Disability Index questionnaire; Device: Body composition analysis using TANITA device; Diagnostic Test: Cervical spine AROM (Active range of motion); Diagnostic Test: Sagittal plane UCS AROM (Upper cervical spine active range of motion); Diagnostic Test: Flexion-Rotation Test; Diagnostic Test: Sidebending-Rotation Test; Diagnostic Test: Axial rotation test C0-C2; Diagnostic Test: Tilting test C0-C1 and C2-C3; Diagnostic Test: Craniocervical flexion test; Diagnostic Test: Craniovertebral angle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cervical Range of Motion
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.
Measured: Baseline
Secondary outcomes (7)
Pain intensity
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.
Measured: Baseline
Quality of Life level
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.
Measured: Baseline
Degree of Functional Disability
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.
Measured: Baseline
Physical activity level
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).
Measured: Baseline
Craniovertebral angle
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).
Measured: Baseline
Activation of the deep flexor muscles
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.
Measured: Baseline
Body composition analysis
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start21 Jun 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Manual TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wroclaw University of Health and Sport Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad de Zaragoza
- Responsible party
- Principal investigator, Katarzyna Wojnicz, Wroclaw University of Health and Sport Sciences
- Investigators
- Katarzyna Wojnicz, Master, Principal investigator, Wroclaw University of Health and Sport Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06642233
- Sponsor's protocol ID
- KWojniczWUHSS
- Status last verified
- Oct 2024
- First submitted
- 23 Jun 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zarate-Tejero CA, Rodriguez-Rubio PR, Brandt L, Krauss J, Hernandez-Secorun M, Lucha-Lopez O, Hidalgo-Garcia C. Association between Age, Sex and Cervical Spine Sagittal Plane Motion: A Descriptive and Correlational Study in Healthy Volunteers. Life (Basel). 2023 Feb 7;13(2):461. doi: 10.3390/life13020461.
PubMed 36836818Zarate-Tejero C, Hidalgo-Garcia C, Lucha-Lopez O, Hernandez-Secorun M, Krauss J, Rodriguez-Rubio P. Association between age, sex and cervical and upper cervical rotation tests. Descriptive and correlational study in healthy volunteers. Ther Adv Chronic Dis. 2023 Apr 29;14:20406223231170158. doi: 10.1177/20406223231170158. eCollection 2023.
PubMed 37152351Gallego-Izquierdo T, Arroba-Diaz E, Garcia-Ascoz G, Val-Cano MDA, Pecos-Martin D, Cano-de-la-Cuerda R. Psychometric Proprieties of a Mobile Application to Measure the Craniovertebral Angle a Validation and Reliability Study. Int J Environ Res Public Health. 2020 Sep 8;17(18):6521. doi: 10.3390/ijerph17186521.
PubMed 32911612Takasaki H, Hall T, Oshiro S, Kaneko S, Ikemoto Y, Jull G. Normal kinematics of the upper cervical spine during the Flexion-Rotation Test - In vivo measurements using magnetic resonance imaging. Man Ther. 2011 Apr;16(2):167-71. doi: 10.1016/j.math.2010.10.002. Epub 2010 Nov 4.
PubMed 21055995Williams MA, McCarthy CJ, Chorti A, Cooke MW, Gates S. A systematic review of reliability and validity studies of methods for measuring active and passive cervical range of motion. J Manipulative Physiol Ther. 2010 Feb;33(2):138-55. doi: 10.1016/j.jmpt.2009.12.009.
PubMed 20170780Youdas JW, Garrett TR, Suman VJ, Bogard CL, Hallman HO, Carey JR. Normal range of motion of the cervical spine: an initial goniometric study. Phys Ther. 1992 Nov;72(11):770-80. doi: 10.1093/ptj/72.11.770.
PubMed 1409874Kovacs FM, Bago J, Royuela A, Seco J, Gimenez S, Muriel A, Abraira V, Martin JL, Pena JL, Gestoso M, Mufraggi N, Nunez M, Corcoll J, Gomez-Ochoa I, Ramirez MJ, Calvo E, Castillo MD, Marti D, Fuster S, Fernandez C, Gimeno N, Carballo A, Milan A, Vazquez D, Canellas M, Blanco R, Brieva P, Rueda MT, Alvarez L, Del Real MT, Ayerbe J, Gonzalez L, Ginel L, Ortega M, Bernal M, Bolado G, Vidal A, Ausin A, Ramon D, Mir MA, Tomas M, Zamora J, Cano A. Psychometric characteristics of the Spanish version of instruments to measure neck pain disability. BMC Musculoskelet Disord. 2008 Apr 9;9:42. doi: 10.1186/1471-2474-9-42.
PubMed 18400084Cleland C, Ferguson S, Ellis G, Hunter RF. Validity of the International Physical Activity Questionnaire (IPAQ) for assessing moderate-to-vigorous physical activity and sedentary behaviour of older adults in the United Kingdom. BMC Med Res Methodol. 2018 Dec 22;18(1):176. doi: 10.1186/s12874-018-0642-3.
PubMed 30577770Rodriguez-Sanz J, Malo-Urries M, Lucha-Lopez MO, Corral-de-Toro J, Gonzalez-Rueda V, Lopez-de-Celis C, Perez-Bellmunt A, Hidalgo-Garcia C. Is Cervical Stabilization Exercise Immediately Effective in Patients with Chronic Neck Pain and Upper Cervical Spine Dysfunction? Randomized Controlled Trial. Life (Basel). 2022 May 11;12(5):714. doi: 10.3390/life12050714.
PubMed 35629381Sarig Bahat H, Weiss PL, Sprecher E, Krasovsky A, Laufer Y. Do neck kinematics correlate with pain intensity, neck disability or with fear of motion? Man Ther. 2014 Jun;19(3):252-8. doi: 10.1016/j.math.2013.10.006. Epub 2013 Nov 9.
PubMed 24291364Audette I, Dumas JP, Cote JN, De Serres SJ. Validity and between-day reliability of the cervical range of motion (CROM) device. J Orthop Sports Phys Ther. 2010 May;40(5):318-23. doi: 10.2519/jospt.2010.3180.
PubMed 20436238Akodu AK, Akinbo SR, Young QO. Correlation among smartphone addiction, craniovertebral angle, scapular dyskinesis, and selected anthropometric variables in physiotherapy undergraduates. J Taibah Univ Med Sci. 2018 Oct 5;13(6):528-534. doi: 10.1016/j.jtumed.2018.09.001. eCollection 2018 Dec.
PubMed 31435373
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationships Among Cervical Functional Test in Patients With Unspecific Neck Pain: a Descriptive and Correlation Study
- ClinicalTrials.gov ID
- NCT06642233
- Acronym / sponsor ID
- KWojniczWUHSS
- 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
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Wroclaw University of Health and Sport SciencesUniversity, hospital or other
- Collaborators
- Universidad de Zaragoza
- Study start
- 21 Jun 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women and men aged 18-75 | – | Diagnostic Test: Socio-demographic survey, Diagnostic Test: Visual Analogue Scale, Diagnostic Test: The World Health Organization Quality-of-Life Scale-BREF questionnaire, Diagnostic Test: The International Physical Activity Questionnaire, Diagnostic Test: The Neck Disability Index questionnaire, Device: Body composition analysis using TANITA device, Diagnostic Test: Cervical spine AROM (Active range of motion), Diagnostic Test: Sagittal plane UCS AROM (Upper cervical spine active range of motion), Diagnostic Test: Flexion-Rotation Test, Diagnostic Test: Sidebending-Rotation Test, Diagnostic Test: Axial rotation test C0-C2, Diagnostic Test: Tilting test C0-C1 and C2-C3, Diagnostic Test: Craniocervical flexion test, Diagnostic Test: Craniovertebral anglePeople with a medical diagnosis of unspecific pain in the cervical spine - acute and chronic pain, regardless of when it began. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (15 listed)
- pregnancy
- pacemaker
- active cancer
- no consent to conduct research
- difficulty communicating
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Socio-demographic surveySocio-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 | Women and men aged 18-75 |
| Visual Analogue ScaleVAS 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 | Women and men aged 18-75 |
| The World Health Organization Quality-of-Life Scale-BREF questionnaireThe 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 | Women and men aged 18-75 |
| The International Physical Activity QuestionnaireThe 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 | Women and men aged 18-75 |
| The Neck Disability Index questionnaireThe 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. | Diagnostic test | Women and men aged 18-75 |
| Body composition analysis using TANITA deviceTANITA 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. | Device | Women and men aged 18-75 |
| 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 | Women and men aged 18-75 |
| 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 | Women and men aged 18-75 |
| Flexion-Rotation TestThe 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 | Women and men aged 18-75 |
| Sidebending-Rotation TestThe 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 | Women and men aged 18-75 |
| Axial rotation test C0-C2The Axial rotation test C0-C2 can be performed using the CROM system. Rotation of the C0-C2 is examined. | Diagnostic test | Women and men aged 18-75 |
| Tilting test C0-C1 and C2-C3The 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 | Women and men aged 18-75 |
| Craniocervical flexion testThe 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 | Women and men aged 18-75 |
| Craniovertebral angleThe 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. | Diagnostic test | Women and men aged 18-75 |
Primary outcome
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.
7 secondary outcomes
Pain intensity
Time frame: Baseline
Quality of Life level
Time frame: Baseline
Degree of Functional Disability
Time frame: Baseline
Physical activity level
Time frame: Baseline
Craniovertebral angle
Time frame: Baseline
Activation of the deep flexor muscles
Time frame: Baseline
Body composition analysis
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Background: PubMed 36836818Zarate-Tejero CA, Rodriguez-Rubio PR, Brandt L, Krauss J, Hernandez-Secorun M, Lucha-Lopez O, Hidalgo-Garcia C. Association between Age, Sex and Cervical Spine Sagittal Plane Motion: A Descriptive and Correlational Study in Healthy Volunteers. Life (Basel). 2023 Feb 7;13(2):461. doi: 10.3390/life13020461.
- Background: PubMed 37152351Zarate-Tejero C, Hidalgo-Garcia C, Lucha-Lopez O, Hernandez-Secorun M, Krauss J, Rodriguez-Rubio P. Association between age, sex and cervical and upper cervical rotation tests. Descriptive and correlational study in healthy volunteers. Ther Adv Chronic Dis. 2023 Apr 29;14:20406223231170158. doi: 10.1177/20406223231170158. eCollection 2023.
- Background: PubMed 32911612Gallego-Izquierdo T, Arroba-Diaz E, Garcia-Ascoz G, Val-Cano MDA, Pecos-Martin D, Cano-de-la-Cuerda R. Psychometric Proprieties of a Mobile Application to Measure the Craniovertebral Angle a Validation and Reliability Study. Int J Environ Res Public Health. 2020 Sep 8;17(18):6521. doi: 10.3390/ijerph17186521.
- Background: PubMed 21055995Takasaki H, Hall T, Oshiro S, Kaneko S, Ikemoto Y, Jull G. Normal kinematics of the upper cervical spine during the Flexion-Rotation Test - In vivo measurements using magnetic resonance imaging. Man Ther. 2011 Apr;16(2):167-71. doi: 10.1016/j.math.2010.10.002. Epub 2010 Nov 4.
- Background: PubMed 20170780Williams MA, McCarthy CJ, Chorti A, Cooke MW, Gates S. A systematic review of reliability and validity studies of methods for measuring active and passive cervical range of motion. J Manipulative Physiol Ther. 2010 Feb;33(2):138-55. doi: 10.1016/j.jmpt.2009.12.009.
- Background: PubMed 1409874Youdas JW, Garrett TR, Suman VJ, Bogard CL, Hallman HO, Carey JR. Normal range of motion of the cervical spine: an initial goniometric study. Phys Ther. 1992 Nov;72(11):770-80. doi: 10.1093/ptj/72.11.770.
- Background: PubMed 18400084Kovacs FM, Bago J, Royuela A, Seco J, Gimenez S, Muriel A, Abraira V, Martin JL, Pena JL, Gestoso M, Mufraggi N, Nunez M, Corcoll J, Gomez-Ochoa I, Ramirez MJ, Calvo E, Castillo MD, Marti D, Fuster S, Fernandez C, Gimeno N, Carballo A, Milan A, Vazquez D, Canellas M, Blanco R, Brieva P, Rueda MT, Alvarez L, Del Real MT, Ayerbe J, Gonzalez L, Ginel L, Ortega M, Bernal M, Bolado G, Vidal A, Ausin A, Ramon D, Mir MA, Tomas M, Zamora J, Cano A. Psychometric characteristics of the Spanish version of instruments to measure neck pain disability. BMC Musculoskelet Disord. 2008 Apr 9;9:42. doi: 10.1186/1471-2474-9-42.
- Background: PubMed 30577770Cleland C, Ferguson S, Ellis G, Hunter RF. Validity of the International Physical Activity Questionnaire (IPAQ) for assessing moderate-to-vigorous physical activity and sedentary behaviour of older adults in the United Kingdom. BMC Med Res Methodol. 2018 Dec 22;18(1):176. doi: 10.1186/s12874-018-0642-3.
- Background: PubMed 35629381Rodriguez-Sanz J, Malo-Urries M, Lucha-Lopez MO, Corral-de-Toro J, Gonzalez-Rueda V, Lopez-de-Celis C, Perez-Bellmunt A, Hidalgo-Garcia C. Is Cervical Stabilization Exercise Immediately Effective in Patients with Chronic Neck Pain and Upper Cervical Spine Dysfunction? Randomized Controlled Trial. Life (Basel). 2022 May 11;12(5):714. doi: 10.3390/life12050714.
- Background: PubMed 24291364Sarig Bahat H, Weiss PL, Sprecher E, Krasovsky A, Laufer Y. Do neck kinematics correlate with pain intensity, neck disability or with fear of motion? Man Ther. 2014 Jun;19(3):252-8. doi: 10.1016/j.math.2013.10.006. Epub 2013 Nov 9.
- Background: PubMed 20436238Audette I, Dumas JP, Cote JN, De Serres SJ. Validity and between-day reliability of the cervical range of motion (CROM) device. J Orthop Sports Phys Ther. 2010 May;40(5):318-23. doi: 10.2519/jospt.2010.3180.
- Background: PubMed 31435373Akodu AK, Akinbo SR, Young QO. Correlation among smartphone addiction, craniovertebral angle, scapular dyskinesis, and selected anthropometric variables in physiotherapy undergraduates. J Taibah Univ Med Sci. 2018 Oct 5;13(6):528-534. doi: 10.1016/j.jtumed.2018.09.001. eCollection 2018 Dec.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katarzyna Wojnicz, Master principal investigator
Wroclaw University of Health and Sport Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Manual Therapy and Cervical Spine, run by Wroclaw University of Health and Sport Sciences at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cervical Range of Motion (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06642233, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024; AzTrials last refreshed its copy on 7 Nov 2026.