Low Back Pain and Core MuscleNCT07003802
Neural Control and Mechanosensation in Spine Muscle
A study testing Resistance exercise in people with Low Back Pain and Core Muscle and Disc Herniation, run by University of California, San Diego at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain and Core Muscle, Disc Herniation
- What is being tested?
- Resistance exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2025to 1 May 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 9Show fewer
- Diabetes
- Neuromuscular diseases
- Epilepsy or other seizure disorder
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Contributions of Neural Control and Mechanosensation to Rehabilitation Induced Spine Muscle Recovery
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.
Read the 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
- Being tested
- Resistance exercise
- Keywords
- low back pain, exercise, physical therapy, surgery
- Medical subject headings
- Low Back Pain, Intervertebral Disc Displacement, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance exerciseBehavioural
An acute bout of a 3 minute resistance exercise will be performed using a lumbar extension exercise machine
| Study group | Role | What they receive |
|---|---|---|
| Resistance exercise | Experimental | An acute bout of a 3 minute resistance exercise will be performed using a lumbar extension exercise machine Receives: Behavioral: Resistance exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
RMS amplitude of paraspinal muscle EMG
Average RMS EMG amplitude of the lumbar multifidus over the duration of the acute exercise bout.
Measured: 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
Measured: Baseline
Cortical excitability
Transcranial Magnetic Stimulation based motor threshold of activation of the lumbar multifidus muscle
Measured: Baseline
pAMPK
Mechanically-induced phosphorylation of p38 MAPK-Thr180/Tyr182 (p-p38T180/Y182) from intraoperative multifidus biopsies or biopsy needle
Measured: Time of surgery/biopsy
Secondary outcomes (5)
MEP amplitude
Motor evoked potential of multifidus in response to Transcranial Magnetic Stimulation of the motor cortex
Measured: Baseline
Cortical Silent Period
Period of motor silence in the multifidus after Transcrianial Magnetic Simulation MEP over the motor cortex
Measured: Baseline
Short Interval Intracortical Inhibition (SICI)
Measurement of signal loss in the multifidus after a paired pulse stimulation of the motor cortex using transcranial magnetic stimulation
Measured: Baseline
Short Interval Intracortical Facilitation (SICF)
Measurement of time of multifidus muscle activation after a paired pulse transcranial magnetic stimulation of the motor cortex
Measured: Baseline
p-mTORS2448/total mTOR
Structural Proteins and phosphorylation of p-mTORS2448/total mTOR measured from intraoperative multifidus biopsies or biopsy needle
Measured: Time of surgery/biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start1 Jul 2025
- Primary completion1 May 2029 (estimated)
- Study completion1 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back Pain and Core MuscleStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bahar Shahidi, University of California, San Diego
- Investigators
- Bahar Shahidi, PT, PhD, Principal investigator, UC San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07003802
- Sponsor's protocol ID
- HD088437-06
- Status last verified
- Apr 2026
- First submitted
- 20 May 2025
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 10 channel EMG data, 2 channel TMS data, MRI images, and biopsy-based signaling and sequencing data
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Contributions of Neural Control and Mechanosensation to Rehabilitation Induced Spine Muscle Recovery
- ClinicalTrials.gov ID
- NCT07003802
- Acronym / sponsor ID
- HD088437-06
- Conditions
- Low Back Pain and Core Muscle, Disc Herniation
- Keywords
- low back pain, exercise, physical therapy, surgery
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 1 May 2029 (estimated)
- Study completion
- 1 May 2030 (estimated)
- First posted
- 4 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Resistance exercise | Experimental | Behavioral: Resistance exerciseAn acute bout of a 3 minute resistance exercise will be performed using a lumbar extension exercise machine |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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),
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistance exerciseAn acute bout of a 3 minute resistance exercise will be performed using a lumbar extension exercise machine | Behavioural | Resistance exercise |
Primary outcome
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.
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
Cortical excitability
Time frame: Baseline
Transcranial Magnetic Stimulation based motor threshold of activation of the lumbar multifidus muscle
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
5 secondary outcomes
MEP amplitude
Time frame: Baseline
Cortical Silent Period
Time frame: Baseline
Short Interval Intracortical Inhibition (SICI)
Time frame: Baseline
Short Interval Intracortical Facilitation (SICF)
Time frame: Baseline
p-mTORS2448/total mTOR
Time frame: Time of surgery/biopsy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: Yes. 10 channel EMG data, 2 channel TMS data, MRI images, and biopsy-based signaling and sequencing data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bahar Shahidi, PT, PhD principal investigator
UC San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance exercise in people with Low Back Pain and Core Muscle and Disc Herniation, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RMS amplitude of paraspinal muscle EMG (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.