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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: Completed NA study, sponsored by University of California, San Diego.

NCT03442374 is a NA study that has completed, run by University of California, San Diego. The registered enrollment target is 62 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

(% fat at 6 months - % fat at baseline / % fat at baseline)

Interventions

  • OTHER Exercise

Trial Details

FieldValue
Enrollment Target 62 participants
Start Date 2019-07-01
Est. Completion 2023-10-01
Phase NA
University of California, San Diego

775 total trials

What the finished NCT03442374 record still lists

NCT03442374 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).

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

NCT03442374 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT03442374's enrollment target sits among peer trials

62 1157th of 2000 higher than 837 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03442374, the US trial registry maintained by the National Library of Medicine. NCT03442374 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.