NCT04417855

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 2, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 5, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

June 8, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2020

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 4, 2020

Completed
Last Updated

August 11, 2020

Status Verified

August 1, 2020

Enrollment Period

1 month

First QC Date

June 2, 2020

Last Update Submit

August 9, 2020

Conditions

Lumbar Disc HerniationProtrusionExtrusion of Migrated DiscHernia

Keywords

degenerative disc diseaseprotrusionextrusiongaitkinematics

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Oswestry Disability Index (ODI)

    15 minutes

Study Arms (2)

LDH

Group of symptomatic individuals with LDH confirmed in MRI.

Diagnostic Test: G-Walk

Control

Group of asymptomatic individuals with no LDH.

Diagnostic Test: G-Walk

Interventions

G-WalkDIAGNOSTIC_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.

ControlLDH

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Primary care clinic, students

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

theMedicine

Wroclaw, Lower Silesian Voivodeship, 50-305, Poland

Location

Related Publications (3)

  • 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.

    PMID: 29448220BACKGROUND

  • 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.

    PMID: 30322623BACKGROUND

  • 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.

    PMID: 28545560BACKGROUND

MeSH Terms

Conditions

Intervertebral Disc DisplacementHerniaIntervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
dr Tomasz Kuligowski

Study Record Dates

First Submitted

June 2, 2020

First Posted

June 5, 2020

Study Start

June 8, 2020

Primary Completion

July 20, 2020

Study Completion

August 4, 2020

Last Updated

August 11, 2020

Record last verified: 2020-08

Locations

PL(1)