Lumbar Intervertebral Motion in Asymptomatic Male Participants

NCT03737227 | Completed DMC

• 1 other identifier: NL63033.096.18
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators aim to analyze the physiological segmental motion of the lumbar spine during flexion and extension cinematographic recordings of asymptomatic individuals.

Conditions

Lumbar Intervertebral Motion

Keywords

Lumbar intervertebral motion; Flexion; Extension; Cinematographic recording; Segmental rotations; Segmental translation; lumbar spine; asymptomatic participants

Outcome Measures

Primary Outcomes (1)

• Lumbar segmental rotation

  Analyzing sequence of initiation of motion and sequence of segmental contribution in rotation of each vertebra L1, L2, L3, L4, L5 and S1 by using flexion and extension cinematographic recordings in asymptomatic male participants.

  30 minutes

Secondary Outcomes (1)

• Lumbar segmental translation

  30 minutes

Study Arms (1)

Cinematographic recording

OTHER

Cinematographic recordings of the asymptomatic participants during flexion and extension of the lumbar spine.Cinematographic recordings will be performed twice with an interval of two weeks.

Radiation: Cinematographic recording

Interventions

Cinematographic recording RADIATION

Cinematographic recording during flexion and extension of the lumbar spine.

Cinematographic recording

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male
• Age between 18 and 25 years old.
• BMI under 25
• Participants have to be able to perform flexion and extension over a full range of motion without complaints of pain.
• Participants have no medical history of spinal problems based on anamneses and zero ODI-, and VAS-score.
• Kellgrens' classification on cinematographic recordings is zero or one.
• Informed consent has been signed.
• Ability to read and understand Dutch.

You may not qualify if:

• Medical history of visiting general practitioners, allied health professionals or specialists for spinal problems.
• Former spine surgery.
• Radiographs of abdomen, pelvis, hips, lumbar spine or sacral spine in last year.
• Degenerative abnormalities of the lumbar spine.
• Active spinal infection.
• Immature bone.
• Lumbar tumor processes.
• Former lumbar radiotherapy.
• Congenital lumbar spine abnormalities, for example spina bifida.
• Planning pregnancy for the coming year.

Sponsors & Collaborators

• Zuyderland Medisch Centrum: lead

Study Sites (1)

Zuyderland Medical Center

Sittard, Limburg, 6162BG, Netherlands

Location

Related Publications (2)

• Caelers I, Boselie T, van Hemert W, Rijkers K, De Bie R, van Santbrink H. The Variability of Lumbar Sequential Motion Patterns: Observational Study. JMIR Biomed Eng. 2023 Jun 20;8:e41906. doi: 10.2196/41906.

  PMID: 38875682 DERIVED

• Caelers IJ, Boselie TF, Rijkers K, Van Hemert WL, De Bie RA, Van Santbrink H. Lumbar Intervertebral Motion Analysis During Flexion and Extension Cinematographic Recordings in Healthy Male Participants: Protocol. JMIR Res Protoc. 2020 Feb 24;9(2):e14741. doi: 10.2196/14741.

  PMID: 32130199 DERIVED

Study Officials

• Henk Van Santbrink, Dr.

  neurosurgeon Zuyderland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Fundamental research with 11 male participants in one study arm, all performingflexion and extension of the lumbar spine during cinematographic recordings twice.

Study Record Dates

• First Submitted: November 2, 2018
• First Posted: November 9, 2018
• Study Start: January 9, 2019
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: January 18, 2020

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)