Clinical trial NCT07003802: Neural Control and Mechanosensation in Spine Muscle
Official title: The Contributions of Neural Control and Mechanosensation to Rehabilitation Induced Spine Muscle Recovery
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Low Back Pain and Core Muscle
Disc Herniation
Keywords: low back pain
exercise
physical therapy
surgery
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2025-06-04
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Chronic Disc Injury or Healthy Control

Brief summary: Low back pain (LBP) is a condition that affects a majority of the US population and is responsible for a significant proportion of health care costs and utilization. Lumbar spine muscle is compromised in LBP, and do, and do not, respond to exercise based physical therapy program depending on measurements representing activation capacity of lumbar muscle. Here, we will characterize the neurological and muscle specific features that may contribute to limited activation in an attempt to identify sources of resistance to recovery in patients with chronic disc injury and identify precision rehabilitation approaches for this complex population of individuals.

Detailed description: 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 injury 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, and paraspinal muscles in these individuals have been shown to be altered in volume, composition, and mechanical properties. These maladaptive changes influence the ability for the muscle to respond appropriately to rehabilitation efforts in a subgroup of individuals with chronic back pain who do not demonstrate the expected acute activation responses to exercise. While the structural and adaptive capacities of healthy muscle are well understood, pathological muscle recovery and activation deficits are less clear and may be influenced by neurogenic and/or muscle specific impairments. To address this gap in knowledge, the purpose of this trial is to compare central and peripheral origins of impaired activation in individuals with chronic disc injury who do, and do not respond to exercise. Experiment 1 will use a novel functional MRI technique and electromyographic measurements to compare responder and non-responder groups in patients with chronic lumbar disc injury undergoing standard physical therapy. Experiment 2 will compare corticomotor excitability and intracortical inhibition and facilitation between individuals who are undergoing physical therapy or surgery who do and do not respond to exercise. Experiment 3 will compare ex vivo passive and active mechanical responses, and transcriptomics from intraoperative multifidus biopsies of patients undergoing spinal surgery for chronic lumbar disc injury to evaluate muscle mechanotransduction. These experiments will elucidate the neurogenic and muscle-specific contributions to muscle adaptation in the presence of chronic lumbar spine pathology and pain.

Eligibility criteria: Inclusion Criteria:

* Surgical group:
* Individuals diagnosed with chronic disc injury (symptoms \> 3 months),
* Individuals planning to undergo a spinal surgery to address the diagnosis of chronic disc injury

Physical Therapy Group-

* Individuals diagnosed with chronic disc injury (symptoms \>3 months),
* Individuals initiating an exercise-based physical therapy program to address the diagnosis of chronic disc injury

Healthy Control group -

* Individuals with no history of chronic back pain (interfering pain lasting \>3 months) within the past 3 years,
* no significant spinal pathology beyond normal age-related degenerative changes

Exclusion Criteria:

* Surgery/Physical therapy groups-History of lumbar spine surgery
* Diabetes
* Neuromuscular diseases
* Epilepsy or other seizure disorder -Healthy control group -
* History of lumbar spine surgery
* History of interfering pain lasting \>3 months
* Diabetes
* Neuromuscular diseases
* Epilepsy or other seizure disorder

Primary outcomes:
measure: RMS amplitude of paraspinal muscle EMG
timeFrame: Baseline
measure: IVIM responsiveness
timeFrame: Baseline
measure: Cortical excitability
timeFrame: Baseline
measure: pAMPK
timeFrame: Time of surgery/biopsy
Secondary outcomes:
measure: MEP amplitude
timeFrame: Baseline
measure: Cortical Silent Period
timeFrame: Baseline
measure: Short Interval Intracortical Inhibition (SICI)
timeFrame: Baseline
measure: Short Interval Intracortical Facilitation (SICF)
timeFrame: Baseline
measure: p-mTORS2448/total mTOR
timeFrame: Time of surgery/biopsy
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UC San Diego
state: California
Study officials:
References: