Clinical trial NCT03737227: Lumbar Intervertebral Motion in Asymptomatic Male Participants
Official title: Analysis of Lumbar Intervertebral Motion During Flexion and Extension Cinematographic Recordings in Asymptomatic Male Participants.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Intervertebral Motion
Keywords: Lumbar intervertebral motion
Flexion
Extension
Cinematographic recording
Segmental rotations
Segmental translation
lumbar spine
asymptomatic participants
Lead sponsor: Zuyderland Medisch Centrum
Sponsor class: OTHER
First posted: 2018-11-09
Enrollment: 11
Sex: MALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Fundamental research with 11 male participants in one study arm, all performingflexion and extension of the lumbar spine during cinematographic recordings twice.
Primary purpose: BASIC_SCIENCE

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Lumbar segmental rotation
timeFrame: 30 minutes
Secondary outcomes:
measure: Lumbar segmental translation
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Sittard
country: Netherlands
facility: Zuyderland Medical Center
state: Limburg
Study officials:
affiliation: neurosurgeon Zuyderland
name: Henk Van Santbrink, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.