Lumbar Intervertebral Motion in Asymptomatic Male Participants

Lumbar Intervertebral Motion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03737227
• Other study ID #: NL63033.096.18
• Status: Completed
• Phase: N/A
• Start date: January 9, 2019
• Est. completion date: January 1, 2020

Study information

• Verified date: February 2019
• Source: Zuyderland Medisch Centrum
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: January 1, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lumbar Intervertebral Motion

Intervention

Radiation:
• Cinematographic recording
Cinematographic recording during flexion and extension of the lumbar spine.

Locations

Country	Name	City	State
Netherlands	Zuyderland Medical Center	Sittard	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Zuyderland Medisch Centrum

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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