Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT07003802

Neural Control and Mechanosensation in Spine Muscle

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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UC San Diego

La Jolla, California, 92093, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Resistance exercise

Behavioral

An acute bout of a 3 minute resistance exercise will be performed using a lumbar extension exercise machine

Primary outcomes

  1. RMS amplitude of paraspinal muscle EMG

    Time frame: Baseline

    Average RMS EMG amplitude of the lumbar multifidus over the duration of the acute exercise bout.

  2. IVIM responsiveness

    Time frame: Baseline

    Response classification from IVIM MRI imaging as an increase in IVIM Diffusion (D) of at least 0.055 x 10-3 mm2/s and a pseudodiffusion (D*) increase of at least 6.94 x 10-3 mm2/s in response to the acute exercise stimulus

  3. Cortical excitability

    Time frame: Baseline

    Transcranial Magnetic Stimulation based motor threshold of activation of the lumbar multifidus muscle

  4. pAMPK

    Time frame: Time of surgery/biopsy

    Mechanically-induced phosphorylation of p38 MAPK-Thr180/Tyr182 (p-p38T180/Y182) from intraoperative multifidus biopsies or biopsy needle

Secondary outcomes

  1. MEP amplitude

    Time frame: Baseline

    Motor evoked potential of multifidus in response to Transcranial Magnetic Stimulation of the motor cortex

  2. Cortical Silent Period

    Time frame: Baseline

    Period of motor silence in the multifidus after Transcrianial Magnetic Simulation MEP over the motor cortex

  3. Short Interval Intracortical Inhibition (SICI)

    Time frame: Baseline

    Measurement of signal loss in the multifidus after a paired pulse stimulation of the motor cortex using transcranial magnetic stimulation

  4. Short Interval Intracortical Facilitation (SICF)

    Time frame: Baseline

    Measurement of time of multifidus muscle activation after a paired pulse transcranial magnetic stimulation of the motor cortex

  5. p-mTORS2448/total mTOR

    Time frame: Time of surgery/biopsy

    Structural Proteins and phosphorylation of p-mTORS2448/total mTOR measured from intraoperative multifidus biopsies or biopsy needle

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Official study title

The Contributions of Neural Control and Mechanosensation to Rehabilitation Induced Spine Muscle Recovery

Important dates

Study start
2025
Primary completion
2029
Study completion
2030
First posted
Jun 4, 2025
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.