Lumbar Kinematics in People With the Low Back Pain

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

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

Study Overview

• Status: Completed
• Conditions: Hernia; Lumbar Disc Herniation; Protrusion; Extrusion of Migrated Disc
• Intervention / Treatment: Diagnostic test: G-Walk

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Poland
  • Dolnośląskie
    • Wrocław, Dolnośląskie, Poland, 50-305
      • theMedicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Primary care clinic, students

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
LDH; Group of symptomatic individuals with LDH confirmed in MRI.	Diagnostic test: G-Walk; 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.
Control; Group of asymptomatic individuals with no LDH.	Diagnostic test: G-Walk; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Timed Up and Go test (TUG)	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.	5 minutes
6-meter walking test	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	5 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oswestry Disability Index (ODI)	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.	15 minutes

Collaborators and Investigators

• Sponsor: University School of Physical Education in Wroclaw

Publications and helpful links

General Publications

• Shahvarpour A, Gagnon D, Preuss R, Henry SM, Lariviere C. Trunk postural balance and low back pain: Reliability and relationship with clinical changes following a lumbar stabilization exercise program. Gait Posture. 2018 Mar;61:375-381. doi: 10.1016/j.gaitpost.2018.02.006. Epub 2018 Feb 9.
• Kuwahara W, Kurumadani H, Tanaka N, Nakanishi K, Nakamura H, Ishii Y, Ueda A, Deie M, Adachi N, Sunagawa T. Correlation between spinal and pelvic movements during gait and aggravation of low back pain by gait loading in lumbar spinal stenosis patients. J Orthop Sci. 2019 Mar;24(2):207-213. doi: 10.1016/j.jos.2018.09.002. Epub 2018 Oct 12.
• Kuai S, Zhou W, Liao Z, Ji R, Guo D, Zhang R, Liu W. Influences of lumbar disc herniation on the kinematics in multi-segmental spine, pelvis, and lower extremities during five activities of daily living. BMC Musculoskelet Disord. 2017 May 25;18(1):216. doi: 10.1186/s12891-017-1572-7.

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2020
• Primary Completion (Actual): July 20, 2020
• Study Completion (Actual): August 4, 2020

Study Registration Dates

• First Submitted: June 2, 2020
• First Submitted That Met QC Criteria: June 2, 2020
• First Posted (Actual): June 5, 2020

Study Record Updates

• Last Update Posted (Actual): August 11, 2020
• Last Update Submitted That Met QC Criteria: August 9, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: gait; degenerative disc disease; kinematics; protrusion; extrusion
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Hernia; Intervertebral Disc Displacement
• Other Study ID Numbers: G-Sensor

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No