Cervical Spine Motion in the Elderly

NCT04222777 | Completed DMC

• 1 other identifier: NL70381.096.19
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cervical Spine Degeneration; Movement, Abnormal; Aging

Keywords

Cervical Motion; Physiological movement; Cervical spine; Segmental Rage of Motion; Elderly; Lower Cervical Spine; Fundamental Research; Cinematographic recordings

Outcome Measures

Primary Outcomes (1)

• Physiologic motion pattern of the lower cervical spine

  The normal sequence of segmental contributions in the lower cervical spine (C4-C5 followed by C5-C6, and then C6-C7) during the second half of extension in asymptomatic participants

  Two recordings will be made with an interval of two weeks and will be analysed within one year. Change will not be assesed. Recordings are made in the same individual at two time points to have to independent objective measurements.

Secondary Outcomes (1)

• Segmental ROM of C4-C5, C5-C6, and C6-C7

  Two recordings will be made with an interval of two weeks and will be analysed within one year. Change will not be assesed. Recordings are made in the same individual at two time points to have to independent objective measurements.

Study Arms (1)

Heatlhy volunteers.

OTHER

Healthy volunteers will undergo two cinematographic recordings of the cervical spine

Diagnostic Test: Cinematographic Recording

Interventions

Cinematographic Recording DIAGNOSTIC_TEST

A cinematographic recording during the second half of extension of the cervical spine will be made during 16 seconds at two timepoints with an interval of two weeks.

Heatlhy volunteers.

Eligibility Criteria

• Age: 55 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 55-70 years.
• Ability to actively perform flexion/extension movements of the neck without pain or other symptoms.
• No history of neck complaints.
• Neck Disability Index (NDI) score of 4 or less.
• Kellgren's score of 3 or less.
• Informed consent

You may not qualify if:

• Previous surgery on the cervical spine.
• Symptoms of cervical radiculopathy of myelopathy (e.g. positive Lhermitte's sign).
• Active infection.
• Immature bone.
• Previous or actual tumorous processes in the cervical region.
• Previous radiation therapy in the cervical region.
• Not able to speak Dutch.

Sponsors & Collaborators

• Zuyderland Medisch Centrum: lead

Study Sites (1)

Zuyderland Medisch Centrum

Heerlen, Limburg, 6419 PC, Netherlands

Location

Related Publications (11)

• Bogduk N, Mercer S. Biomechanics of the cervical spine. I: Normal kinematics. Clin Biomech (Bristol). 2000 Nov;15(9):633-48. doi: 10.1016/s0268-0033(00)00034-6.

  PMID: 10946096 BACKGROUND

• Van Mameren H, Drukker J, Sanches H, Beursgens J. Cervical spine motion in the sagittal plane (I) range of motion of actually performed movements, an X-ray cinematographic study. Eur J Morphol. 1990;28(1):47-68.

  PMID: 2390411 BACKGROUND

• Boselie TFM, van Santbrink H, de Bie RA, van Mameren H. Pilot Study of Sequence of Segmental Contributions in the Lower Cervical Spine During Active Extension and Flexion: Healthy Controls Versus Cervical Degenerative Disc Disease Patients. Spine (Phila Pa 1976). 2017 Jun 1;42(11):E642-E647. doi: 10.1097/BRS.0000000000001914.

  PMID: 27879563 BACKGROUND

• Reinartz R, Platel B, Boselie T, van Mameren H, van Santbrink H, Romeny Bt. Cervical vertebrae tracking in video-fluoroscopy using the normalized gradient field. Med Image Comput Comput Assist Interv. 2009;12(Pt 1):524-31. doi: 10.1007/978-3-642-04268-3_65.

  PMID: 20426028 BACKGROUND

• Simpson AK, Biswas D, Emerson JW, Lawrence BD, Grauer JN. Quantifying the effects of age, gender, degeneration, and adjacent level degeneration on cervical spine range of motion using multivariate analyses. Spine (Phila Pa 1976). 2008 Jan 15;33(2):183-6. doi: 10.1097/BRS.0b013e31816044e8.

  PMID: 18197104 BACKGROUND

• Lansade C, Laporte S, Thoreux P, Rousseau MA, Skalli W, Lavaste F. Three-dimensional analysis of the cervical spine kinematics: effect of age and gender in healthy subjects. Spine (Phila Pa 1976). 2009 Dec 15;34(26):2900-6. doi: 10.1097/BRS.0b013e3181b4f667.

  PMID: 20010397 BACKGROUND

• Cote P, Cassidy JD, Yong-Hing K, Sibley J, Loewy J. Apophysial joint degeneration, disc degeneration, and sagittal curve of the cervical spine. Can they be measured reliably on radiographs? Spine (Phila Pa 1976). 1997 Apr 15;22(8):859-64. doi: 10.1097/00007632-199704150-00007.

  PMID: 9127918 BACKGROUND

• Boselie TF, van Mameren H, de Bie RA, van Santbrink H. Cervical spine kinematics after anterior cervical discectomy with or without implantation of a mobile cervical disc prosthesis; an RCT. BMC Musculoskelet Disord. 2015 Feb 21;16:34. doi: 10.1186/s12891-015-0479-4.

  PMID: 25887569 BACKGROUND

• KELLGREN JH, LAWRENCE JS. Radiological assessment of osteo-arthrosis. Ann Rheum Dis. 1957 Dec;16(4):494-502. doi: 10.1136/ard.16.4.494. No abstract available.

  PMID: 13498604 BACKGROUND

• 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: 1834753 BACKGROUND

• Schuermans VNE, Smeets AYJM, Breen A, Branney J, Curfs I, van Santbrink H, Boselie TFM. An observational study of quality of motion in the aging cervical spine: sequence of segmental contributions in dynamic fluoroscopy recordings. BMC Musculoskelet Disord. 2024 Apr 25;25(1):330. doi: 10.1186/s12891-024-07423-z.

  PMID: 38664811 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Dyskinesias

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Henk Van Santbrink, MD, PhD, Prof

  Maastricht University Medical Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Not applicable. All participants are healthy volunteers.
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Fundamental research. Cinemathographic recordings will be made in healthy volunteers to determine physiological range of motion in the cervical spine. No health outcome of the intervention will be assessed.

Study Record Dates

• First Submitted: October 29, 2019
• First Posted: January 10, 2020
• Study Start: October 10, 2019
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2020
• Last Updated: November 6, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will be available for the duration of the study, which is estimated to be one year. Data will be stored safely at the MUMC for 15 years.

Locations

NL (1)