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Completed

NCT Number: NCT04417855

Lumbar Kinematics in People With the Low Back Pain

This study evaluates the effect of lumbar disc herniation on kinematics in the lumbopelvic region during daily living activities.

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Key information

Conditions

Lumbar Disc Herniation Bone Diseases Extrusion of Migrated Disc Hernia Intervertebral Disc Degeneration Intervertebral Disc Displacement Musculoskeletal Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Protrusion Spinal Diseases

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Observational

Primary location

theMedicine

Wroclaw, Lower Silesian Voivodeship, 50-305, Poland

About this study

Lumbar disc herniation (LDH) is one of the causes of low back pain and contributes to increasing the socio-economic problem. Depending on the reason for the dysfunction, various classifications describing the level of advancement are used. The literature on the subject commonly uses the division into protrusion and extrusion of the intervertebral disc, as approved by the American Society of Neuroradiology.

The lumbopelvic kinematics, including gait and daily living activities, can be affected by the LDH: protrusion or extrusion. This pathology may be different due to the direction of disc migration: centre, left, right or all mentioned. Therefore, we believe that from the different direction of the disc migration the different symptoms can be observed.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • disc disease located in the lumbar region of the spine confirmed in the MRI
  • subacute stage of the disease
  • age 18-35 years

Exclusion criteria

  • advanced degenerative-deformation changes of the spine
  • previous fracture of the spine
  • neurologic deficits in lower limbs or pelvis
  • spondylolisthesis
  • transitional vertebra
  • rheumatic diseases

Treatment and study plan

G-Walk

Diagnostic Test

Every individual will be examined with a non-invasive "G-Walk" device which is a sensor mounted on a belt and fasten on individuals' lumbar spine region during two test activities: Timed up and go and 6-meter walk tests. Data collection will include kinematic parameters. Oswestry Disability Index (ODI) score will also be collected.

Primary outcomes

  1. Timed Up and Go test (TUG)

    Time frame: 5 minutes

    The sensor mounted on the belt in lumbar 2nd (L2) vertebra. Following data will be obtained:

    Spatio-temporal parameters standing phase, sitting phase and rotations, trunk kinematics (flexion and/or extension angle) will be collected.

  2. 6-meter walking test

    Time frame: 5 minutes

    The sensor mounted on the belt in lumbar 5th (L5) vertebra. Following data will be obtained:

    Total distance travelled general spatio-temporal parameters, variation in spatio-temporal parameters during the 6 minutes walking, pelvis kinematics

Secondary outcomes

  1. Oswestry Disability Index (ODI)

    Time frame: 15 minutes

    The Oswestry Disability Index (ODI) is a valid and reliable assessment tool used by clinicians and researchers to quantify disability for low back pain. The self-completed questionnaire contains ten sections concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel.

    For each section the total possible score is 5: if the first statement is marked the section score = 0; if the last statement is marked, it = 5. After completing, the score is calculated by by summing scores from all sections (total maximum points=50). Total results are calculated as a percentage. The higher the score, the subject's condition is worse.

    The results are interpreted as follows:

    0% to 20%: minimal disability 21%-40%: moderate disability 41%-60%: severe disability 61%-80%: crippled 81%-100%:These patients are either bed-bound or exaggerating their symptoms.

Sponsors and collaborators

Lead sponsor

Wroclaw University of Health and Sport Sciences

Other

Registry information

Official study title

The Effect of Lumbar Disc Herniation on the Kinematics in Lumbo-pelvic Region During Daily Living Activities.

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 5, 2020
Registry last updated
Aug 11, 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.

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