Lumbar Disc HerniationNCT04417855
Lumbar Kinematics in People With the Low Back Pain
An observational study of Lumbar Disc Herniation and Protrusion, run by Wroclaw University of Health and Sport Sciences at 1 site in Poland.
Trial summary
This study evaluates the effect of lumbar disc herniation on kinematics in the lumbopelvic region during daily living activities. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Lumbar Disc Herniation, Protrusion, Extrusion of Migrated Disc
- What is being tested?
- G-Walk
- How many people
- 30 participants
- Where
- 1 sitePoland
- Study dates
- 8 Jun 2020to 4 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Primary care clinic, students
Who may be able to join
- disc disease located in the lumbar region of the spine confirmed in the MRI
- subacute stage of the disease
- age 18-35 years
Who cannot join
- advanced degenerative-deformation changes of the spine
- previous fracture of the spine
- neurologic deficits in lower limbs or pelvis
- spondylolisthesis
- transitional vertebra
- rheumatic diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Lumbar Disc Herniation, Protrusion, Extrusion of Migrated Disc, Hernia
- Being tested
- G-Walk
- Keywords
- degenerative disc disease, protrusion, extrusion, gait, kinematics
- Medical subject headings
- Intervertebral Disc Displacement, Hernia, Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| LDH | Group of symptomatic individuals with LDH confirmed in MRI. Receives: Diagnostic Test: G-Walk | |
| Control | Group of asymptomatic individuals with no LDH. Receives: Diagnostic Test: G-Walk |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 5 minutes
Secondary outcomes (1)
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.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study start8 Jun 2020
- Primary completion20 Jul 2020
- Study completion4 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lumbar Disc HerniationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wroclaw University of Health and Sport Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tomasz Kuligowski, Wroclaw University of Health and Sport Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04417855
- Sponsor's protocol ID
- G-Sensor
- Status last verified
- Aug 2020
- First submitted
- 2 Jun 2020
- Last updated
- 11 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 29448220Kuwahara 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.
PubMed 30322623Kuai 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.
PubMed 28545560
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Lumbar Disc Herniation on the Kinematics in Lumbo-pelvic Region During Daily Living Activities.
- ClinicalTrials.gov ID
- NCT04417855
- Acronym / sponsor ID
- G-Sensor
- Conditions
- Lumbar Disc Herniation, Protrusion, Extrusion of Migrated Disc, Hernia
- Keywords
- degenerative disc disease, protrusion, extrusion, gait, kinematics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Wroclaw University of Health and Sport SciencesUniversity, hospital or other
- Study start
- 8 Jun 2020 (actual)
- Primary completion
- 20 Jul 2020 (actual)
- Study completion
- 4 Aug 2020 (actual)
- First posted
- 5 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the effect of lumbar disc herniation on kinematics in the lumbopelvic region during daily living activities.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LDH | – | Diagnostic Test: G-WalkGroup of symptomatic individuals with LDH confirmed in MRI. |
| Control | – | Diagnostic Test: G-WalkGroup of asymptomatic individuals with no LDH. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Primary care clinic, students
Key inclusion criteria (3 listed)
- disc disease located in the lumbar region of the spine confirmed in the MRI
- subacute stage of the disease
- age 18-35 years
Key exclusion criteria (6 listed)
- advanced degenerative-deformation changes of the spine
- previous fracture of the spine
- neurologic deficits in lower limbs or pelvis
- spondylolisthesis
- transitional vertebra
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| G-WalkEvery 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. | Diagnostic test | Control, LDH |
Primary outcome
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.
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
1 secondary outcome
Oswestry Disability Index (ODI)
Time frame: 15 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2020.
- Background: PubMed 29448220Shahvarpour 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.
- Background: PubMed 30322623Kuwahara 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.
- Background: PubMed 28545560Kuai 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Disc Herniation and Protrusion, run by Wroclaw University of Health and Sport Sciences at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timed Up and Go test (TUG) (time frame: 5 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04417855, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2020.