Lumbar Spine Muscle Degeneration Inhibits Rehabilitation-Induced Muscle Recovery

NCT03442374 | Completed

• 1 other identifier: HD088437
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Disc Degeneration; Low Back Pain

Keywords

Multifidus; Muscle; Degeneration; Lumbar Spine; Disc

Outcome Measures

Primary Outcomes (1)

• Change in Multifidus Muscle Fatty Infiltration

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

  6 months

Secondary Outcomes (59)

• Change in Oswestry Disability Index (ODI)

  6 Months

• Change in Fear Avoidance Beliefs Questionnaire (FABQ)

  6 months

• Change in Pain Catastrophizing Scale (PCS)

  6 months

• Change in Activated Muscle Volume (%)

  After exercise (within 5 minutes)

• Change in Pain (VAS)

  6 months

Study Arms (2)

Exercise

EXPERIMENTAL

A single bout of moderate intensity lumbar extensor muscle exercise.

Other: Exercise

Non-exercise

NO INTERVENTION

No exercise intervention.

Interventions

Exercise OTHER

The exercise protocol consists of 1 set of 20 repetitions (range 15-25 reps) at a rate of 5 seconds/repetitions with a starting weight of 60-80% of their computerized strength score. Patients will be instructed to target an exertion level of 7/10 on the Borg Rate of Perceived Exertion (RPE) scale within their available passive ROM range into flexion-extension

Exercise

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Spine pathologies requiring un-instrumented surgery (i.e. laminectomy, laminoforaminotomy, or discectomy).
• Age 21-85 years of age.

You may not qualify if:

• History of lumbar spine surgery.
• Patients requiring placement of instrumentation as part of the surgical procedure (i.e. fusion).
• Diabetes.
• Neuromuscular diseases.

Sponsors & Collaborators

• University of California, San Diego: lead
• Balgrist University Hospital: collaborator
• Spine Institute of San Diego (Spine Zone): collaborator

Study Sites (1)

UC San Diego

La Jolla, California, 92093, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration; Low Back Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Vice Chair of Research

Model Details: Stratified by fatty infiltration severity (n=20/group x 2 groups + non exercise controls n=20)

Study Record Dates

• First Submitted: February 9, 2018
• First Posted: February 22, 2018
• Study Start: July 1, 2019
• Primary Completion: June 1, 2023
• Study Completion: October 1, 2023
• Last Updated: November 28, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)