NCT04222777

Cervical Spine Motion in the Elderly

Completed NA Last updated 6 November 2020

What this trial tests

NA trial testing Cinematographic Recording in Cervical Spine Degeneration in 10 participants. Completed in 1 February 2020.

Timeline

10 October 2019

Primary endpoint
1 February 2020

1 February 2020

Quick facts

Lead sponsor	Zuyderland Medisch Centrum
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	basic science
Enrollment	10
Start date	10 October 2019
Primary completion	1 February 2020
Estimated completion	1 February 2020
Sites	1 location across Netherlands

Drugs / interventions tested

• Cinematographic Recording

Conditions studied

• Cervical Spine Degeneration — all drugs for Cervical Spine Degeneration →
• Movement, Abnormal — all drugs for Movement, Abnormal →
• Aging — all drugs for Aging →

Sponsor

Zuyderland Medisch Centrum — full company profile →

Who can join

Adults 55 to 70, any sex, with Cervical Spine Degeneration or Movement, Abnormal. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Rationale:

Physiological motion of the cervical spine is a subject of interest for medical specialists. Segmental range of motion (sROM) has been most commonly used to define motion but inter- and intra-variability is large. Therefore, a sequence of segmental contributions in the lower cervical spine during the second half of extension has been defined in healthy participants (uniform in 80-90%). The mean age of these participants was 23 years. Since cervical degenerative disc disease (CDDD) occurs more often in elderly patients, it is of paramount importance to study whether this sequence remains present during aging, regardless of losing 0.11 degrees of sROM each year.

Objective:

To investigate if the normal sequence of segmental contributions in the lower cervical spine during the second half of extension (C4-C5 followed by C5-C6, and then C6- C7) is also present in asymptomatic participants between 55 and 70 years of age by using cinematographic recordings.

Study design:

Fundamental research

Study population:

Eleven asymptomatic participants between 55 and 70 years of age, without a medical history of neck problems, with a score of 4 or less on the Neck Disability Index (NDI), and without severe degenerative changes based on a score of 3 or less on the radiological Kellgrens' classification.

Intervention:

Two flexion and extension cinematographic recordings of the cervical spine with a two-week interval between recordings.

Main study parameters/endpoints:

Primary endpoint: Defining the cervical spines' physiological motion pattern by analysing the normal sequence of segmental contributions in the lower cervical spine (C4-C5 followed by C5-C6, and then C6-C7) during the second halfof extension in asymptomatic participants between 55 and 70 years of age.

Secondary endpoint: Determine sROM of C4-C5, C5-C6, and C6-C7 by analysing the flexion and extension cinematographic recordings in asymptomatic participants between 55 and 70 years of age.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Participants receive cinematographic recordings twice. There will be no follow-up.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. An observational study of quality of motion in the aging cervical spine: sequence of segmental contributions in dynamic fluoroscopy recordings.
   Schuermans VNE, Smeets AYJM, Breen A, Branney J, et al · · 2024 · cited 5× · PMID 38664811 · DOI 10.1186/s12891-024-07423-z
2. AI-Assisted Image Recognition of Cervical Spine Vertebrae in Dynamic X-Ray Recordings.
   van Santbrink E, Schuermans V, Cerfonteijn E, Breeuwer M, et al · · 2025 · cited 2× · PMID 40722371 · DOI 10.3390/bioengineering12070679
3. Improved AI-Assisted Image Recognition of Cervical Spine Vertebrae Enables Motion Pattern Analysis in Dynamic X-Ray Recordings.
   van Santbrink E, Hijzelaar THW, Schuermans VNE, Smeets AYJM, et al · · 2026 · PMID 41899882 · DOI 10.3390/bioengineering13030351