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Asymptomatic ConditionNCT07267507

Accessory Movements and Associated Factors During Active Cervical Range of Motion

An observational study of Asymptomatic Condition and Neck Pain, run by Atılım University at 1 site in Turkey (Türkiye).

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This project aims to quantify accessory movements that occur during cervical range of motion (ROM) assessment in young adults and to examine their relationship with functional and psychological factors. Read more about this study

Who is it for?
Ages 18 to 35 yearsHealthy volunteers can take part
Conditions the study is for
Asymptomatic Condition, Neck Pain
How many people
180 participants
Where
1 siteTurkey (Türkiye)
Study dates
30 Apr 2024to 15 Jan 2026
How long will I take part?
1 Day
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 35 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Study population: The study population will consist of young adults aged 18-30 years who volunteer to participate and meet the inclusion criteria. Only individuals without cervical trauma, surgery, neurological disorders, recent treatment, musculoskeletal injuries, or medication use affecting cervical movement will be included, ensuring a homogeneous non-clinical sample suitable for accurately evaluating accessory cervical movements.

Who may be able to join

  • Are between 18 and 30 years of age
  • Volunteer to participate in the study
  • Provide written informed consent.
  • Exclusion Criteria:Participants will be excluded if they have:
  • A history of cervical trauma
  • A history of cervical spine surgery
Show all 11Show fewer
  • Any neurological disorder
  • Received treatment related to the cervical region within the past 6 months
  • Any musculoskeletal injury that may affect cervical movement
  • Use of medications that could influence movement or neuromuscular function.
  • -

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Atılım University

    Ankara, Ankara, 06830

Other trials in Turkey (Türkiye)

About this study

This project aims to quantify accessory movements that occur during cervical range of motion (ROM) assessment in young adults and to examine their relationship with functional and psychological factors. Although cervical ROM is widely used in clinical practice, accurate measurement is challenged by the complex anatomy of the cervical spine and coupled movements, which may alter true motion values. Despite their clinical relevance, accessory movements have been largely overlooked in both research and routine assessment.

This cross-sectional observational study will include volunteers aged 18-30 years, recruited between January and August 2025 following ethical approval. Individuals with cervical trauma or surgery, neurological disease, recent treatment, musculoskeletal injury, or medications affecting movement will be excluded. Accessory movements will be measured using the CROM device while participants perform flexion-extension, lateral flexion, and rotation, maintaining end-range for 20 seconds to record primary and accessory motions.

Clinical outcomes will include cervical disability (Neck Disability Index), pain intensity (Visual Analog Scale), cervical mechanosensitivity (pressure algometry at the upper trapezius and C2-C7 regions), psychological status (Depression, Anxiety, Stress Scale-21), and sleep quality (Pittsburgh Sleep Quality Index).

Read the detailed description

Range of motion (ROM) is a routinely accepted parameter used by physiotherapists and other health professionals in the evaluation of spinal movements, serving as both a baseline and outcome measure for documenting disability and the effects of interventions, as well as for adjusting physiotherapy treatment plans. However, due to the complex anatomy of the cervical spine and its associated movements, accurate measurement of cervical ROM remains challenging.

A variety of tools have been developed to assess cervical mobility, ranging from simple visual inspection to advanced three-dimensional motion analysis systems, including goniometers, inclinometers, CROM devices, Optotrak and Vicon systems, radiographic techniques, and smartphone applications.

The anatomy of the cervical spine and the presence of "coupled movements" make the measurement of cervical ROM particularly difficult. Coupled movements refer to accessory motions that accompany a primary target movement. For example, when an individual flexes the head forward while simultaneously rotating it laterally, flexion is considered the primary movement, whereas the accompanying lateral flexion and axial rotation are accessory movements. The complex structure of the functional units of the cervical spine permits the combination of multi-axial movements rather than isolated single-axis motions. Movements of adjacent vertebrae are guided by the geometry of the articular surfaces, which allows the combination of ipsilateral rotation with lateral flexion. At the lower cervical levels, the orientation of the apophyseal joints and the presence of cervical lordosis may lead lateral flexion to be accompanied by ipsilateral rotation and slight extension. Other studies have emphasized the variability in movement patterns that arise due to the presence of these coupled motions, even during simple tasks. Additionally, research has demonstrated that accessory movements can cause substantial variation in the magnitude of the primary movement.

At the structural level of the cervical spine, multiple movement strategies may be used to achieve a specific functional goal. The number of studies describing accessory movements as involuntary patterns developed in the presence of cervical pain is limited, and those that exist vary depending on the measurement technique and participant characteristics. By revealing the impact of often-neglected accessory movements during the assessment of active cervical ROM, the present project aims to introduce conceptual and methodological innovations to cervical mobility evaluation methods. Considering the scarcity of research on this topic, the proposed project will provide a unique contribution to clinical assessment and treatment strategies.

To the best of our knowledge, although there are a limited number of studies investigating the presence of accessory movements during cervical ROM measurement, no research has explored the factors associated with these movements. A better understanding of the characteristics of ROM impairments may help clarify the clinical significance of these relationships. However, in both the literature and clinical practice, the magnitude of accessory movements occurring during cervical ROM has generally been overlooked. The present project addresses this important gap by quantifying accessory movements and, for the first time, comprehensively examining their relationship with both physical and psychological limitations in young individuals. In this context, the project is expected to contribute to the development of more specific and individualized treatment algorithms for individuals with cervical spine dysfunction.

Keywords
Cervical Vertebrae, Range of Motion, Pain, Sleep, Depression
Medical subject headings
Asymptomatic Diseases, Neck Pain, Pain, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07267507
Study groupRoleWhat they receive
Proprioceptive Dysfunction GroupIndividuals with proprioceptive error (more than 4 degree)
Non-Error GroupIndividuals without proprioceptive error-less than 4 degree

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assessment of Accessory Movements

    Accessory movements occurring during active cervical ROM will be evaluated using the Cervical Range of Motion (CROM) device. In a seated position, the participant's neutral resting posture will first be recorded. Subsequently, they will be instructed to perform flexion, extension, right lateral flexion, left lateral flexion, right rotation, and left rotation in sequence. At the end of each movement, participants will hold the end position for 20 seconds, during which the primary movement and the accessory movements occurring in the other two planes will be recorded.

    Measured: 0-18 months

  2. Assessment of Cervical Disability

    Cervical disability will be assessed using the Neck Disability Index (NDI), a widely used instrument for evaluating cervical spine dysfunction. The NDI consists of 10 items that measure the impact of neck-related problems on daily activities, including pain intensity, personal care, lifting, reading, headaches, concentration, work status, driving, sleep, and recreational activities. Each item is scored on a scale from 0 to 5, resulting in a total score ranging from 0 to 50. A score of 0 indicates no disability or functional limitation, whereas a score of 50 reflects severe functional impairment. It is recommended that the total score be converted into a percentage, interpreted as follows: 0-4 (no disability), 5-14 (mild disability), 15-24 (moderate disability), 25-34 (severe disability), and 35-50 (complete or very severe disability).

    Measured: 0-18 months

  3. Assessment of Pain Intensity

    Pain intensity will be assessed using the Visual Analog Scale (VAS). The VAS consists of a 10-cm (100-mm) horizontal line anchored by the descriptors "no pain" at one end and "worst imaginable pain" at the other. Participants will mark the point on the line that represents the intensity of pain they experience, and the distance in millimeters from the "no pain" anchor to the marked point will be recorded as the pain score.

    Measured: 0-18 months

  4. Assessment of Cervical Mechanosensitivity

    Cervical muscle mechanosensitivity will be evaluated using a pressure algometer (Baseline Force Gauge Model 12-0304; Baseline, NY, USA). The device applies force perpendicular to the tissue through a 0.5 cm² probe at an approximate rate of 3 N/s. With the participant seated, pressure will be applied bilaterally to the midpoint of the upper trapezius muscle and to points located 2 cm lateral to the C2 and C7 articular pillars. Pressure algometry has demonstrated high intra-rater (ICC = 0.94-0.97) and inter-rater reliability (ICC = 0.79-0.90) in individuals with neck pain.

    Participants will be instructed to indicate the moment when the pressure sensation first becomes uncomfortable. This value, defined as the pressure pain threshold (PPT), will be recorded twice with at least 30 seconds between trials, and the mean of the two measurements will be used for analysis.

    Measured: 0-18 months

  5. Assessment of Depression, Anxiety, and Stress:

    Depression, anxiety, and stress levels will be assessed using the Depression, Anxiety, and Stress Scale-21 (DASS-21). The DASS-21 consists of three subscales-depression, anxiety, and stress-each comprising 7 items. Scores for each subscale are summed and then multiplied by two, yielding a maximum possible score of 42 per domain. Higher scores indicate greater symptom severity. Recommended cut-off ranges vary for each construct: for depression, 0-9 (normal) to ≥28 (extremely severe); for anxiety, 0-7 (normal) to ≥20 (extremely severe); and for stress, 0-14 (normal) to ≥34 (extremely severe).

    Measured: 0-18 months

  6. Assessment of Sleep Disturbances

    Sleep disturbances will be assessed using the Pittsburgh Sleep Quality Index (PSQI). The PSQI is a 19-item questionnaire designed to evaluate sleep habits over the past month and comprises seven components. The total score ranges from 0 to 21, with higher scores indicating poorer sleep quality. A global score of 5 or above is considered indicative of sleep disturbance.

    Measured: 0-18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Dec 2025
  2. Study start30 Apr 2024
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion15 Jan 2026 (estimated)

Resources

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
Other
Time perspective
Cross-sectional
Enrolment
180 participants (estimated)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT07267507
Sponsor's protocol ID
Atılım University-25
Status last verified
Nov 2025
First submitted
25 Nov 2025
Last updated
5 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Ağargün, M.Y., H. Kara, and Ö. Anlar, The validity and reliability of the Pittsburgh Sleep Quality Index. Turk Psikiyatri Derg, 1996. 7(2): p. 107-15.

  • Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.

    PubMed 2748771
  • Sariçam, H., The psychometric properties of Turkish version of Depression Anxiety Stress Scale-21 (DASS-21) in health control and clinical samples. Journal of Cognitive Behavioral Psychotherapies and Research, 2018. 7(1): p. 19.

  • Lovibond, S.H., Manual for the depression anxiety stress scales. Sydney psychology foundation, 1995.

  • McCormack HM, Horne DJ, Sheather S. Clinical applications of visual analogue scales: a critical review. Psychol Med. 1988 Nov;18(4):1007-19. doi: 10.1017/s0033291700009934.

    PubMed 3078045
  • Vernon H, Mior S. The Neck Disability Index: a study of reliability and validity. J Manipulative Physiol Ther. 1991 Sep;14(7):409-15.

    PubMed 1834753
  • Aslan E, Karaduman A, Yakut Y, Aras B, Simsek IE, Yagly N. The cultural adaptation, reliability and validity of neck disability index in patients with neck pain: a Turkish version study. Spine (Phila Pa 1976). 2008 May 15;33(11):E362-5. doi: 10.1097/BRS.0b013e31817144e1.

    PubMed 18469684
  • Law EY, Chiu TT. Measurement of cervical range of motion (CROM) by electronic CROM goniometer: a test of reliability and validity. J Back Musculoskelet Rehabil. 2013;26(2):141-8. doi: 10.3233/BMR-2012-00358.

    PubMed 23640315
  • Lysell E. Motion in the cervical spine. An experimental study on autopsy specimens. Acta Orthop Scand. 1969:Suppl 123:1+. doi: 10.3109/ort.1969.40.suppl-123.01. No abstract available.

    PubMed 4907116
  • Harrison DE, Harrison DD, Cailliet R, Janik TJ, Troyanovich SJ. Cervical coupling during lateral head translations creates an S-configuration. Clin Biomech (Bristol). 2000 Jul;15(6):436-40. doi: 10.1016/s0268-0033(99)00098-4.

    PubMed 10771122
  • Boussion, L. and L. Chèze, Étude cinématique tridimensionnelle du rachis cervical: Comparaison entre sujets asymptomatiques et "pathologiques". Kinésithérapie, la Revue, 2011. 11(109-110): p. 36-37.

  • Mangone M, Bernetti A, Germanotta M, Di Sipio E, Razzano C, Ioppolo F, Santilli V, Venditto T, Paoloni M. Reliability of the Cervical Spine Device for the Assessment of Cervical Spine Range of Motion in Asymptomatic Participants. J Manipulative Physiol Ther. 2018 May;41(4):342-349. doi: 10.1016/j.jmpt.2018.01.003.

    PubMed 29751851
  • Cuesta-Vargas AI, Galan-Mercant A, Williams JM. The use of inertial sensors system for human motion analysis. Phys Ther Rev. 2010 Dec;15(6):462-473. doi: 10.1179/1743288X11Y.0000000006.

    PubMed 23565045
  • Tucci SM, Hicks JE, Gross EG, Campbell W, Danoff J. Cervical motion assessment: a new, simple and accurate method. Arch Phys Med Rehabil. 1986 Apr;67(4):225-30.

    PubMed 3964055
  • Frost M, Stuckey S, Smalley LA, Dorman G. Reliability of measuring trunk motions in centimeters. Phys Ther. 1982 Oct;62(10):1431-7. doi: 10.1093/ptj/62.10.1431.

    PubMed 7122701

Questions about this trial

What is this clinical trial studying?

An observational study of Asymptomatic Condition and Neck Pain, run by Atılım University at 1 site in Turkey (Türkiye).

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 11 inclusion and 0 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 5 Dec 2025. 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 Turkey (Türkiye). 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?

Assessment of Accessory Movements (time frame: 0-18 months). The study lists 6 primary outcomes in all. 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 NCT07267507, which also lists 20 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 5 Dec 2025.

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