Neural Control and Mechanosensation in Spine Muscle

NCT07003802 | Enrolling By Invitation

• 1 other identifier: HD088437-06
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain and Core Muscle; Disc Herniation

Keywords

low back pain; exercise; physical therapy; surgery

Outcome Measures

Primary Outcomes (4)

• RMS amplitude of paraspinal muscle EMG

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

  Baseline

• IVIM responsiveness

  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

  Baseline

• Cortical excitability

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

  Baseline

• pAMPK

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

  Time of surgery/biopsy

Secondary Outcomes (5)

• MEP amplitude

  Baseline

• Cortical Silent Period

  Baseline

• Short Interval Intracortical Inhibition (SICI)

  Baseline

• Short Interval Intracortical Facilitation (SICF)

  Baseline

• p-mTORS2448/total mTOR

  Time of surgery/biopsy

Study Arms (1)

Resistance exercise

EXPERIMENTAL

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

Behavioral: Resistance exercise

Interventions

Resistance exercise BEHAVIORAL

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

Resistance exercise

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

UC San Diego

La Jolla, California, 92093, United States

Location

MeSH Terms

Conditions

Low Back Pain; Intervertebral Disc Displacement; Motor Activity

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Bahar Shahidi, PT, PhD

  UC San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 20, 2025
• First Posted: June 4, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2030
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: All scientific data generated from this project will be made available as soon as possible, after the time of publication or the end of the funding period, whichever comes first. The duration of preservation and sharing of the data will be a minimum of 10 years after the funding period.
• Access Criteria: We will make the de-identified data set available via an access code provided to interested investigators upon approval by an honest broker housed within the Department of Orthopedics in conjunction with the IRB.

Locations

US (1)