Paraspinal Muscle Remodeling

NCT03753711 | Completed

• 1 other identifier: LDH-UH
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Lumbar Disc Herniation

Keywords

lumbar disc herniation; hernia

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (9)

• Numeric Pain Rating Score (NPRS)

  day 1

• Numeric Pain Rating Score (NPRS)

  week 6

• Numeric Pain Rating Score (NPRS)

  month 6

• Modified Oswestry Disability Index (ODI)

  day1

• Modified Oswestry Disability Index (ODI)

  week 6

Study Arms (1)

LDH (lumbar disc hernia)

EXPERIMENTAL

Procedure: Multifidus muscle biopsy during minimally invasive back surgery

Interventions

Multifidus muscle biopsy during minimally invasive back surgery PROCEDURE

Bilateral biopsy of the multifidus muscle in patient with a unilateral disc hernia.

LDH (lumbar disc hernia)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hasselt University: lead
• Ziekenhuis Oost-Limburg: collaborator
• Jessa Hospital: collaborator

Study Sites (1)

Jessa Ziekenhuis

Hasselt, 3500, Belgium

Location

MeSH Terms

Conditions

Intervertebral Disc Displacement; Hernia

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Frank Vandenabeele, prof. dr.

  Hasselt University

  PRINCIPAL INVESTIGATOR

• Sjoerd Stevens, drs.

  Hasselt University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 22, 2018
• First Posted: November 27, 2018
• Study Start: July 1, 2018
• Primary Completion: August 31, 2021
• Study Completion: August 31, 2021
• Last Updated: May 19, 2022

Record last verified: 2022-05

Locations

BE (1)