Neural Control and Mechanosensation in Spine Muscle

NCT ID: NCT07003802

Last Updated: 2025-06-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2033-04-01

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.

Conditions

Low Back Pain and Core Muscle; Disc Herniation

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Physical Therapy cohort

Individuals who have been prescribed and are initiating an exercise based physical therapy program for their low back pain

Resistance exercise

Intervention Type: BEHAVIORAL

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

Surgical Cohort

Individuals who are undergoing surgical management for chronic disc disease

Resistance exercise

Intervention Type: BEHAVIORAL

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

Healthy Cohort

Individuals with no history of low back pain or pathology

Resistance exercise

Intervention Type: BEHAVIORAL

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

Interventions

Resistance exercise

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Bahar Shahidi

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

UC San Diego

La Jolla, California, United States

Countries

United States

Central Contacts

Bahar Shahidi, DPT, PhD

Role: CONTACT

bshahidi@health.ucsd.edu

858-822-0439

Samuel R Ward, PT, PhD

Role: CONTACT

s1ward@health.ucsd.edu

Facility Contacts

Bahar Shahidi, DPT, PhD

Role: primary

bshahidi@health.ucsd.edu

858-822-0439

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

HD088437-06

Identifier Type: -

Identifier Source: org_study_id