Lumbar Disc HerniationNCT03753711
Paraspinal Muscle Remodeling
A study testing Multifidus muscle biopsy during minimally invasive back surgery in people with Lumbar Disc Herniation, run by Hasselt University at 1 site in Belgium.
Trial summary
Lumbar disc herniation is the most common diagnosed degenerative pathology in the lumbar spine with a prevalence of 2 to 3% in the adult population. Unilateral lumbar disc herniation is characterized by compression or irritation of the lumbar nerve roots or dural sac by either protrusion, extrusion or sequestration of… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Lumbar Disc Herniation
- What is being tested?
- Multifidus muscle biopsy during minimally invasive back surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jul 2018to 31 Aug 2021
- Phase
- Interventional
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Unilateral lumbar disc hernia (diagnosed using MRI)
- Age between 18-55
- Understanding the Dutch language
Who cannot join
- Spinal surgery within the last year
- Degenerative or other spinal pathology (except disc hernia)
- Contraindications to undergo a MRI
- Other known pathologies that might affect muscle biology/ morphology
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Paraspinal Muscle Remodeling in Patients With Unilateral Lumbar Disc Herniation
Lumbar disc herniation is the most common diagnosed degenerative pathology in the lumbar spine with a prevalence of 2 to 3% in the adult population. Unilateral lumbar disc herniation is characterized by compression or irritation of the lumbar nerve roots or dural sac by either protrusion, extrusion or sequestration of the nucleus pulposus, mostly in the posterolateral region. Compression or irritation of the lumbar nerve roots and dural sac can induce unilateral sensory and motor symptoms. Therefore, it is the principal cause of lumbar spinal surgery.
Different imaging studies have investigated asymmetry of the paraspinal muscles in patient with unilateral low back pain due to lumbar discus herniation. Both animal and human studies indicate a reduction in total muscle cross-sectional area, increased fat infiltration and fibrosis within the lumbar multifidus at the affected side.
Read more
Increased fat infiltration is clinically important because there is a correlation between the amount of intramuscular fat and lumbar muscle dysfunction. Not only fat infiltration correlates with lumbar dysfunction, also a lower multifidus cross-sectional area is associated with and predictive for low back pain. This indicates that there is an association between paraspinal muscle changes/ remodeling and muscle dysfunction that could lead to low back pain.
The aim of this research is to quantify the decrease in muscle and muscle fibre size, the amount of fat infiltration, and the amount of fibrosis present within the multifidus muscle at the herniated side in relation to the unaffected side. The second aim is to investigate the possible role of different cell types in the process of muscle remodeling. The last aim of this study is to correlate these muscular changes with long-term functional outcomes such as pain, fear and disability. This information can possibly contribute to the etiology of paraspinal muscle changes, and provide a handgrip to future research.
- Conditions
- Lumbar Disc Herniation
- Being tested
- Multifidus muscle biopsy during minimally invasive back surgery
- Keywords
- lumbar disc herniation, hernia
- Medical subject headings
- Intervertebral Disc Displacement, Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multifidus muscle biopsy during minimally invasive back surgeryProcedure or surgery
Bilateral biopsy of the multifidus muscle in patient with a unilateral disc hernia.
| Study group | Role | What they receive |
|---|---|---|
| LDH (lumbar disc hernia) | Experimental | Not described Receives: Procedure: Multifidus muscle biopsy during minimally invasive back surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
muscle biopsy sample (musculus multifidus)
Histochemical analyses: Masson's trichrome and haematoxylin and eosin staining will be used to visualize connective and adipose tissues within a muscle cross-section.
Measured: day 1
muscle biopsy sample (musculus multifidus)
Immunofluorescent analyses: Primary and secondary immunofluorescent antibody's against MHC I, IIA and IIX, laminin, satellite cells / muscle stem cells (PAX-7, MyoD, Myogenin), fibro-adipogenic cells/ mesenchymal progenitor cells (PDGFR-alfa) and myonuclei (DAPI) will be used.
Measured: day 1
muscle biopsy sample (musculus multifidus)
Real-time PCR: Inflammatory markers and growth factors will be measured using real-time polymerase chain reaction.
Measured: day 1
MRI
Medical imaging: Pre-operative MRI images will be requested from the department of radiology to measure total muscle cross-sectional area and intramuscular fat infiltration.
Measured: day 1
Secondary outcomes (9)
Numeric Pain Rating Score (NPRS)
this is a tool to provide an indication of the amount of pain a participant is feeling. It's a scale with 11 scores (0-10). It's a scale in which score 0 means 'no pain' and score 10 means 'the highest imaginable pain'. An improvement of 2 levels is considered clinically relevant.
Measured: day 1
Numeric Pain Rating Score (NPRS)
this is a tool to provide an indication of the amount of pain a participant is feeling. It's a scale with 11 scores (0-10). It's a scale in which score 0 means 'no pain' and score 10 means 'the highest imaginable pain'. An improvement of 2 levels is considered clinically relevant.
Measured: week 6
Numeric Pain Rating Score (NPRS)
this is a tool to provide an indication of the amount of pain a participant is feeling. It's a scale with 11 scores (0-10). It's a scale in which score 0 means 'no pain' and score 10 means 'the highest imaginable pain'. An improvement of 2 levels is considered clinically relevant.
Measured: month 6
Modified Oswestry Disability Index (ODI)
this is a questionnaire than has been proven valid and reliable to evaluate the restrictions that people with low back pain experience during their daily living. It consist of 10 items that will be scored on a 5 point scale. Using the total score you can calculate a percentage restriction degree. The score is calculated using the sum of the scores (0-5) from all 10 questions and multiply them times two. The final score is interpreted as following: 0-20%: minimal disability, 21-40%: moderate disability, 41-60%: severe disability, 61-80%: crippled, 81-100% bed bound.
Measured: day1
Modified Oswestry Disability Index (ODI)
this is a questionnaire than has been proven valid and reliable to evaluate the restrictions that people with low back pain experience during their daily living. It consist of 10 items that will be scored on a 5 point scale. Using the total score you can calculate a percentage restriction degree. The score is calculated using the sum of the scores (0-5) from all 10 questions and multiply them times two. The final score is interpreted as following: 0-20%: minimal disability, 21-40%: moderate disability, 41-60%: severe disability, 61-80%: crippled, 81-100% bed bound.
Measured: week 6
Modified Oswestry Disability Index (ODI)
this is a questionnaire than has been proven valid and reliable to evaluate the restrictions that people with low back pain experience during their daily living. It consist of 10 items that will be scored on a 5 point scale. Using the total score you can calculate a percentage restriction degree. The score is calculated using the sum of the scores (0-5) from all 10 questions and multiply them times two. The final score is interpreted as following: 0-20%: minimal disability, 21-40%: moderate disability, 41-60%: severe disability, 61-80%: crippled, 81-100% bed bound.
Measured: month 6
Tampa Scale for Kinesiophobia (TSK)
this is an ordinal 17 item questionnaire that inventories pain-related fear of movement for persons with subacute and chronic low back pain or fibromyalgia. A higher score relates to more pain-related fear. A score >37/68 (with 68 being the highest possible score) means there is fear of movement present.
Measured: day 1
Tampa Scale for Kinesiophobia (TSK)
this is an ordinal 17 item questionnaire that inventories pain-related fear of movement for persons with subacute and chronic low back pain or fibromyalgia. A higher score relates to more pain-related fear. A score >37/68 (with 68 being the highest possible score) means there is fear of movement present.
Measured: week 6
Tampa Scale for Kinesiophobia (TSK)
this is an ordinal 17 item questionnaire that inventories pain-related fear of movement for persons with subacute and chronic low back pain or fibromyalgia. A higher score relates to more pain-related fear. A score >37/68 (with 68 being the highest possible score) means there is fear of movement present.
Measured: month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study start1 Jul 2018
- Primary completion31 Aug 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Collaborators
- Ziekenhuis Oost-Limburg, Jessa Hospital
- Responsible party
- Principal investigator, Frank Vandenabeele, Hasselt University
- Investigators
- Frank Vandenabeele, prof. dr., Principal investigator, Hasselt UniversitySjoerd Stevens, drs., Study chair, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03753711
- Sponsor's protocol ID
- LDH-UH
- Status last verified
- May 2022
- First submitted
- 22 Nov 2018
- Last updated
- 19 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paraspinal Muscle Remodeling in Patients With Unilateral Lumbar Disc Herniation
- ClinicalTrials.gov ID
- NCT03753711
- Acronym / sponsor ID
- LDH-UH
- Conditions
- Lumbar Disc Herniation
- Keywords
- lumbar disc herniation, hernia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Collaborators
- Ziekenhuis Oost-Limburg, Jessa Hospital
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 27 Nov 2018 (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.
Lumbar disc herniation is the most common diagnosed degenerative pathology in the lumbar spine with a prevalence of 2 to 3% in the adult population. Unilateral lumbar disc herniation is characterized by compression or irritation of the lumbar nerve roots or dural sac by either protrusion, extrusion or sequestration of the nucleus pulposus, mostly in the posterolateral region. Compression or irritation of the lumbar nerve roots and dural sac can induce unilateral sensory and motor symptoms. Therefore, it is the principal cause of lumbar spinal surgery.
Different imaging studies have investigated asymmetry of the paraspinal muscles in patient with unilateral low back pain due to lumbar discus herniation. Both animal and human studies indicate a reduction in total muscle cross-sectional area, increased fat infiltration and fibrosis within the lumbar multifidus at the affected side.
Increased fat infiltration is clinically important because there is a correlation between the amount of intramuscular fat and lumbar muscle dysfunction. Not only fat infiltration correlates with lumbar dysfunction, also a lower multifidus cross-sectional area is associated with and predictive for low back pain. This indicates that there is an association between paraspinal muscle changes/ remodeling and muscle dysfunction that could lead to low back pain.
The aim of this research is to quantify the decrease in muscle and muscle fibre size, the amount of fat infiltration, and the amount of fibrosis present within the multifidus muscle at the herniated side in relation to the unaffected side. The second aim is to investigate the possible role of different cell types in the process of muscle remodeling. The last aim of this study is to correlate these muscular changes with long-term functional outcomes such as pain, fear and disability. This information can possibly contribute to the etiology of paraspinal muscle changes, and provide a handgrip to future research.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LDH (lumbar disc hernia) | Experimental | Procedure: Multifidus muscle biopsy during minimally invasive back surgery |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Unilateral lumbar disc hernia (diagnosed using MRI)
- Age between 18-55
- Understanding the Dutch language
Key exclusion criteria (4 listed)
- Spinal surgery within the last year
- Degenerative or other spinal pathology (except disc hernia)
- Contraindications to undergo a MRI
- Other known pathologies that might affect muscle biology/ morphology
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 |
|---|---|---|
| Multifidus muscle biopsy during minimally invasive back surgeryBilateral biopsy of the multifidus muscle in patient with a unilateral disc hernia. | Procedure or surgery | LDH (lumbar disc hernia) |
Primary outcome
muscle biopsy sample (musculus multifidus)
Time frame: day 1
Histochemical analyses: Masson's trichrome and haematoxylin and eosin staining will be used to visualize connective and adipose tissues within a muscle cross-section.
muscle biopsy sample (musculus multifidus)
Time frame: day 1
Immunofluorescent analyses: Primary and secondary immunofluorescent antibody's against MHC I, IIA and IIX, laminin, satellite cells / muscle stem cells (PAX-7, MyoD, Myogenin), fibro-adipogenic cells/ mesenchymal progenitor cells (PDGFR-alfa) and myonuclei (DAPI) will be used.
muscle biopsy sample (musculus multifidus)
Time frame: day 1
Real-time PCR: Inflammatory markers and growth factors will be measured using real-time polymerase chain reaction.
MRI
Time frame: day 1
Medical imaging: Pre-operative MRI images will be requested from the department of radiology to measure total muscle cross-sectional area and intramuscular fat infiltration.
9 secondary outcomes
Numeric Pain Rating Score (NPRS)
Time frame: day 1
Numeric Pain Rating Score (NPRS)
Time frame: week 6
Numeric Pain Rating Score (NPRS)
Time frame: month 6
Modified Oswestry Disability Index (ODI)
Time frame: day1
Modified Oswestry Disability Index (ODI)
Time frame: week 6
Modified Oswestry Disability Index (ODI)
Time frame: month 6
Tampa Scale for Kinesiophobia (TSK)
Time frame: day 1
Tampa Scale for Kinesiophobia (TSK)
Time frame: week 6
Tampa Scale for Kinesiophobia (TSK)
Time frame: month 6
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 19 May 2022.
Related trials for Lumbar Disc Herniation
Not yet recruiting
Selective Nerve Root Block Versus Sham to Reduce Surgery for Lumbar Disc Herniation
Lumbar Disc Herniation, Lumbar Radiculopathy
Not yet recruiting
H-Reflex-Guided Direction-Sensitive Exercise Versus Standard Extension Exercise for Functional Recovery in Patients With Lumbar Disc Prolapse
Lumber Disc Prolapse
RecruitingObservational study
Pulmonary Mechanics and Cerebral Oxygenation During Prone Lumbar Disc Surgery
Lumbar Disc Herniation, Respiratory Mechanics
Not yet recruiting
Randomized Evaluation of Lumbar Injection Effectiveness and Function
Lumbar Radiculopathy, Lumbar Disc Herniation
Recruiting
More Realistic Spine Patients: Assessing the Effect of Dialogue Support Tool.
Spinal Stenosis Lumbar, Disc Herniation, Lumbar
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.
Frank Vandenabeele, prof. dr. principal investigator
Hasselt University
Sjoerd Stevens, drs. study chair
Hasselt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multifidus muscle biopsy during minimally invasive back surgery in people with Lumbar Disc Herniation, run by Hasselt University at 1 site in Belgium.
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 4 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 19 May 2022. 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 Belgium. 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?
muscle biopsy sample (musculus multifidus) (time frame: day 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 May 2022.