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OpenTrials
Completed

NCT Number: NCT03737227

Lumbar Intervertebral Motion 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.

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Key information

Age range

18 year–25 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Zuyderland Medical Center

Sittard, Limburg, 6162BG, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cinematographic recording

Radiation

Cinematographic recording during flexion and extension of the lumbar spine.

Primary outcomes

  1. Lumbar segmental rotation

    Time frame: 30 minutes

    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.

Secondary outcomes

  1. Lumbar segmental translation

    Time frame: 30 minutes

    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.

Sponsors and collaborators

Lead sponsor

Zuyderland Medisch Centrum

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 9, 2018
Registry last updated
Jan 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.