Lumbar Intervertebral Motion in Asymptomatic Male Participants

Analysis of Lumbar Intervertebral Motion During Flexion and Extension Cinematographic Recordings in Asymptomatic Male Participants.

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

Study Overview

• Status: Completed
• Conditions: Lumbar Intervertebral Motion
• Intervention / Treatment: Radiation: Cinematographic recording

Detailed Description

In this study the investigators aim to define the lumbar spines' physiological motion by analyzing sequence of initiation of motion and sequence of maximum contribution in segmental translation and rotation of each vertebra L1, L2, L3, L4, L5 and S1 by using flexion and extension cinematographic recordings in asymptomatic male participants. Participants will undergo two cinematographic recordings with an interval of two weeks. Segmental translation and rotation of each segment will be plotted against total range of motion of the lumbar spine for each individual participant. With these graphs the investigators can analyze if there are specific physiological motion patterns during flexion and extension of the lumbar spine. In the future, the investigators hope to compare these physiological motion patterns to potential abnormal motion patterns in patients suffering from lumbar spinal pathology or after lumbar spine surgery to gain knowledge about complaints and, for example, adjacent level disease.

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Limburg
    • Sittard, Limburg, Netherlands, 6162BG
      • Zuyderland Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 25 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Cinematographic recording; 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; Cinematographic recording during flexion and extension of the lumbar spine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lumbar segmental translation	Analyzing intervertebral horizontal and vertical translation of each vertebra L1, L2, L3, L4, L5 and S1 by using flexion and extension cinematographic recordings in asymptomatic male participants. If mean intra-class correlation coefficient is higher than 0.60, sequence of initiation of motion and sequence of segmental contribution of intervertebral horizontal and vertical translation will be analyzed.	30 minutes

Collaborators and Investigators

• Sponsor: Zuyderland Medisch Centrum
• Investigators: Principal Investigator: Henk Van Santbrink, Dr., neurosurgeon Zuyderland

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2019
• Primary Completion (Actual): January 1, 2020
• Study Completion (Actual): January 1, 2020

Study Registration Dates

• First Submitted: November 2, 2018
• First Submitted That Met QC Criteria: November 8, 2018
• First Posted (Actual): November 9, 2018

Study Record Updates

• Last Update Posted (Actual): January 18, 2020
• Last Update Submitted That Met QC Criteria: January 14, 2020
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: lumbar spine; Extension; Lumbar intervertebral motion; Flexion; Cinematographic recording; Segmental rotations; Segmental translation; asymptomatic participants
• Other Study ID Numbers: NL63033.096.18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No