Lumbar Intervertebral Motion in Asymptomatic Male Participants

NCT ID: NCT03737227

Last Updated: 2020-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-09

Study Completion Date

2020-01-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Lumbar Intervertebral Motion

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Cinematographic recording

Intervention Type RADIATION

Cinematographic recording during flexion and extension of the lumbar spine.

Interventions

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Cinematographic recording

Cinematographic recording during flexion and extension of the lumbar spine.

Intervention Type RADIATION

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Zuyderland Medisch Centrum

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Henk Van Santbrink, Dr.

Role: PRINCIPAL_INVESTIGATOR

neurosurgeon Zuyderland

Locations

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Zuyderland Medical Center

Sittard, Limburg, Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type DERIVED
PMID: 38875682 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32130199 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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NL63033.096.18

Identifier Type: -

Identifier Source: org_study_id

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