Lumbar Intervertebral Motion in Asymptomatic Male Participants
NCT ID: NCT03737227
Last Updated: 2020-01-18
Study Results
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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COMPLETED
NA
11 participants
INTERVENTIONAL
2019-01-09
2020-01-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
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.
Cinematographic recording
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
25 Years
MALE
Yes
Sponsors
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Zuyderland Medisch Centrum
OTHER
Responsible Party
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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
Countries
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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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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NL63033.096.18
Identifier Type: -
Identifier Source: org_study_id
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