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NCT03442374 · ClinicalTrials.gov registry record · NA

Lumbar Spine Muscle Degeneration Inhibits Rehabilitation-Induced Muscle Recovery

A NA study, sponsored by University of California, San Diego.

Completed
Registry status
NA
Development phase
62
Enrollment target

NCT03442374 is a NA study that has completed, run by University of California, San Diego. The registered enrollment target is 62 participants.

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The verdict

NCT03442374, a NA study, has completed, sponsored by University of California, San Diego.

COMPLETED
Registry status
NA
Development phase
62 participants
Enrollment target

Study Summary

Low back pain (LBP) is a complex condition that affects 65-85% of the population, and is the leading musculoskeletal condition contributing to disability in the United States. Disc herniation is the most common injury and 75% of individuals undergoing surgical and rehabilitative interventions for this condition experience suboptimal or poor outcomes. These patients demonstrate disability and deficits in functional capacity, including strength and endurance of the lumbar musculature. Muscle-specific changes in individuals with LBP include altered muscle volume, fatty infiltration and fibrosis, and fiber area and type. Importantly, these changes are insensitive to rehabilitation in patients with continued chronic or recurrent symptoms. While normal disuse-related atrophy in the presence of LBP is expected, more severe or chronic pathology, such as inflammation and fiber damage, may be inducing irreversible fiber degeneration and fatty/fibrotic tissue changes that impair muscle function and recovery. While the structural and adaptive capacities of healthy muscle are well understood, muscle recovery in the presence of pathology is less clear. To address this gap in knowledge, the purpose of this project is to compare structural, physiological, and adaptive responses of muscle in the presence of acute and chronic lumbar spine pathology. The central hypothesis is that chronic injury results in a state of muscle inflammation, atrophy, fibrosis, and muscle degeneration that is not responsive to exercise. The Investigators will identify which patients respond to exercise by examining muscle hypertrophic, fibrotic, inflammatory, and adipogenic gene expression profiles. Patients will be followed for six months post-operatively to measure muscle recovery and strength.

Interventions

  • OTHER Exercise

Trial Details

FieldValue
Enrollment Target 62 participants
Start Date 2019-07-01
Est. Completion 2023-10-01
Phase NA

Sponsor

University of California, San Diego

775 total trials

What the Registry Record Tells You About NCT03442374

The ClinicalTrials.gov registry entry for NCT03442374 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 62 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Diego, which has 775 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Exercise is the first listed.

NCT03442374 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03442374 about?

NCT03442374 is a clinical study titled "Lumbar Spine Muscle Degeneration Inhibits Rehabilitation-Induced Muscle Recovery". Low back pain (LBP) is a complex condition that affects 65-85% of the population, and is the leading musculoskeletal condition contributing to disability in the United States. Disc herniation is the most common injury and 75% of individuals undergoing surgical and rehabilitative interventions for th...

What is the current status of trial NCT03442374?

This trial is currently completed. It is a NA study. The enrollment target is 62 participants. The study started on 2019-07-01. Estimated completion is 2023-10-01.

What interventions are being tested in trial NCT03442374?

The interventions under investigation include: Exercise (OTHER).

Who is sponsoring clinical trial NCT03442374?

This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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