Lumbar Kinematics in People With the Low Back Pain

Lumbar Disc Herniation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04417855
• Other study ID #: G-Sensor
• Status: Completed
• Start date: June 8, 2020
• Est. completion date: August 4, 2020

Study information

• Verified date: August 2020
• Source: University School of Physical Education in Wroclaw
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 4, 2020
• Est. primary completion date: July 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Extrusion of Migrated Disc
• Hernia
• Lumbar Disc Herniation
• Protrusion

Intervention

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.

Locations

Country	Name	City	State
Poland	theMedicine	Wroclaw	Dolnoslaskie

Sponsors (1)

Lead Sponsor	Collaborator
University School of Physical Education in Wroclaw

Country where clinical trial is conducted

Poland, 

References & Publications (3)

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. — View Citation

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. — View Citation

Shahvarpour A, Gagnon D, Preuss R, Henry SM, Larivière 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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