Paraspinal Muscle Remodeling

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.

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 Overview

• Status: Completed
• Conditions: Lumbar Disc Herniation
• Intervention / Treatment: Procedure: Multifidus muscle biopsy during minimally invasive back surgery

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Hasselt, Belgium, 3500
    • Jessa Ziekenhuis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Unilateral lumbar disc hernia (diagnosed using MRI)
• Age between 18-55
• Understanding the Dutch language

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LDH (lumbar disc hernia)	Procedure: Multifidus muscle biopsy during minimally invasive back surgery; Bilateral biopsy of the multifidus muscle in patient with a unilateral disc hernia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	day 1
muscle biopsy sample (musculus multifidus)	Real-time PCR: Inflammatory markers and growth factors will be measured using real-time polymerase chain reaction.	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.	day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	month 6

Collaborators and Investigators

• Sponsor: Hasselt University
• Collaborators: Jessa Hospital; Ziekenhuis Oost-Limburg
• Investigators: Principal Investigator: Frank Vandenabeele, prof. dr., Hasselt University; Study Chair: Sjoerd stevens, drs., Hasselt University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Actual): August 31, 2021
• Study Completion (Actual): August 31, 2021

Study Registration Dates

• First Submitted: November 22, 2018
• First Submitted That Met QC Criteria: November 22, 2018
• First Posted (Actual): November 27, 2018

Study Record Updates

• Last Update Posted (Actual): May 19, 2022
• Last Update Submitted That Met QC Criteria: May 18, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: lumbar disc herniation; hernia
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Hernia; Intervertebral Disc Displacement
• Other Study ID Numbers: LDH-UH

Drug and device information, study documents

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