NCT07267507

Brief 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. 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).

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 30, 2024

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

November 25, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 5, 2025

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2026

Completed
Last Updated

December 5, 2025

Status Verified

November 1, 2025

Enrollment Period

1.7 years

First QC Date

November 25, 2025

Last Update Submit

November 25, 2025

Conditions

Keywords

Cervical VertebraeRange of MotionPainSleepDepression

Outcome Measures

Primary Outcomes (6)

  • 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.

    0-18 months

  • 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).

    0-18 months

  • 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.

    0-18 months

  • 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.

    0-18 months

  • 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).

    0-18 months

  • 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.

    0-18 months

Study Arms (2)

Proprioceptive Dysfunction Group

Individuals with proprioceptive error (more than 4 degree)

Non-Error Group

Individuals without proprioceptive error-less than 4 degree

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Are between 18 and 30 years of age
  • Volunteer to participate in the study
  • Provide written informed consent.

You may not qualify if:

  • A history of cervical trauma
  • A history of cervical spine surgery
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atılım University

Ankara, Ankara, 06830, Turkey (Türkiye)

Location

Related Publications (20)

  • 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.

    BACKGROUND
  • 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.

    PMID: 2748771BACKGROUND
  • 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.

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

    BACKGROUND
  • 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.

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

    PMID: 1834753BACKGROUND
  • 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.

    PMID: 18469684BACKGROUND
  • 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.

    PMID: 23640315BACKGROUND
  • 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.

    PMID: 4907116BACKGROUND
  • 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.

    PMID: 10771122BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 29751851BACKGROUND
  • 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.

    PMID: 23565045BACKGROUND
  • 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.

    PMID: 3964055BACKGROUND
  • 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.

    PMID: 7122701BACKGROUND
  • Sukari AAA, Singh S, Bohari MH, Idris Z, Ghani ARI, Abdullah JM. Examining the Range of Motion of the Cervical Spine: Utilising Different Bedside Instruments. Malays J Med Sci. 2021 Apr;28(2):100-105. doi: 10.21315/mjms2021.28.2.9. Epub 2021 Apr 21.

    PMID: 33958964BACKGROUND
  • Audette 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.

    PMID: 20436238BACKGROUND
  • Yoon TL, Kim HN, Min JH. Validity and Reliability of an Inertial Measurement Unit-based 3-Dimensional Angular Measurement of Cervical Range of Motion. J Manipulative Physiol Ther. 2019 Jan;42(1):75-81. doi: 10.1016/j.jmpt.2018.06.001.

    PMID: 31054596BACKGROUND
  • Jonas R, Demmelmaier R, Hacker SP, Wilke HJ. Comparison of three-dimensional helical axes of the cervical spine between in vitro and in vivo testing. Spine J. 2018 Mar;18(3):515-524. doi: 10.1016/j.spinee.2017.10.065. Epub 2017 Oct 23.

    PMID: 29074465BACKGROUND
  • de Koning CH, van den Heuvel SP, Staal JB, Smits-Engelsman BC, Hendriks EJ. Clinimetric evaluation of active range of motion measures in patients with non-specific neck pain: a systematic review. Eur Spine J. 2008 Jul;17(7):905-21. doi: 10.1007/s00586-008-0656-3. Epub 2008 Apr 22.

    PMID: 18427843BACKGROUND

MeSH Terms

Conditions

Asymptomatic DiseasesNeck PainPainDepression

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and SymptomsBehavioral SymptomsBehavior

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof.

Study Record Dates

First Submitted

November 25, 2025

First Posted

December 5, 2025

Study Start

April 30, 2024

Primary Completion

December 31, 2025

Study Completion

January 15, 2026

Last Updated

December 5, 2025

Record last verified: 2025-11

Locations