Paraspinal Muscle Remodeling

NCT ID: NCT03753711

Last Updated: 2022-05-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-01
• Study Completion Date: 2021-08-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

LDH (lumbar disc hernia)

Group Type: EXPERIMENTAL

Multifidus muscle biopsy during minimally invasive back surgery

Intervention Type: PROCEDURE

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

Interventions

Multifidus muscle biopsy during minimally invasive back surgery

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ziekenhuis Oost-Limburg

OTHER

Sponsor Role: collaborator

Jessa Hospital

OTHER

Sponsor Role: collaborator

Hasselt University

OTHER

Sponsor Role: lead

Responsible Party

Frank Vandenabeele

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Frank Vandenabeele, prof. dr.

Role: PRINCIPAL_INVESTIGATOR

Hasselt University

Sjoerd Stevens, drs.

Role: STUDY_CHAIR

Hasselt University

Locations

Jessa Ziekenhuis

Hasselt, , Belgium

Countries

Belgium

Other Identifiers

LDH-UH

Identifier Type: -

Identifier Source: org_study_id