Paraspinal Muscle Remodeling

NCT03753711 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-05-19

No results posted yet for this study

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

Interventions

PROCEDURE

Multifidus muscle biopsy during minimally invasive back surgery

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

Sponsors & Collaborators

  • Ziekenhuis Oost-Limburg

    collaborator OTHER
  • Jessa Hospital

    collaborator OTHER
  • Hasselt University

    lead OTHER

Principal Investigators

  • Frank Vandenabeele, prof. dr. · Hasselt University

  • Sjoerd Stevens, drs. · Hasselt University

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-01
Primary Completion
2021-08-31
Completion
2021-08-31

Countries

  • Belgium

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03753711 on ClinicalTrials.gov