Chronic Non-specific Low Back Pain With Lumbar Multifidus Muscle Injury or DysfunctionNCT07892846
The Intervention Effect of Exercise on Lumbar Multifidus Muscle Injuries
A study testing Lumbar multifidus muscle rehabilitation exercise in people with Chronic Non-specific Low Back Pain With Lumbar Multifidus Muscle Injury or Dysfunction, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
This is a single-center, prospective interventional study. The main purpose is to use ultrasound radiomics to analyze changes in multifidus muscle ultrasound imaging features before and after rehabilitation therapy in patients with low back pain related to lumbar multifidus injury, and explore whether these imaging… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Non-specific Low Back Pain With Lumbar Multifidus Muscle Injury or Dysfunction
- What is being tested?
- Lumbar multifidus muscle rehabilitation exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Oct 2026to May 2027
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-80 years old, no restriction on gender.
- Diagnosed with non-specific low back pain with disease duration ≥ 3 months.
- Numerical Rating Scale (NRS) / Visual Analog Scale (VAS) pain score ≥ 1 point.
- Clinically suspected lumbar multifidus muscle injury or dysfunction, with at least one abnormal finding of lumbar multifidus muscle on baseline ultrasound examination, including reduced resting thickness, left-right asymmetry, decreased cross-sectional area or increased echogenicity.
- Able to understand the research content and voluntarily sign the informed consent form.
- Able to cooperate to complete rehabilitation training and follow-up assessments.
Who cannot join
- Presence of specific causes of low back pain, such as lumbar infection, tumor, fracture, inflammatory spondyloarthropathy, etc.
- Obvious nerve root compression symptoms, cauda equina syndrome or progressive neurological deficits.
- Previous history of lumbar spine surgery.
- Severe lumbar spondylolisthesis, severe spinal stenosis, severe osteoporosis or other conditions unsuitable for rehabilitation training.
- Complicated with severe cardiopulmonary disease, malignant tumor, systemic infection or other diseases intolerant to training.
- Pregnant or lactating women.
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- Received systematic lumbar back rehabilitation training, local block/injection therapy or other interventions that may affect outcome assessment within the past 4 weeks.
- Combined with severe mental disorders, cognitive impairment or poor compliance, unable to cooperate with the study.
- Patients with long-term use of hormones or analgesic medications.
- Other conditions judged by the investigator to be inappropriate for enrollment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Chinese PLA General Hospital
Beijing, Beijing Municipality
Mingbo Zhang, MD, +8613552744805, owsifanduizhe@126.com
About this study
Official title: A Therapeutic Effect Evaluation System for Multifidus Muscle Injury in the Lumbar Region Was Constructed Based on Ultrasound Radiomics
This is a single-center, prospective interventional study. The main purpose is to use ultrasound radiomics to analyze changes in multifidus muscle ultrasound imaging features before and after rehabilitation therapy in patients with low back pain related to lumbar multifidus injury, and explore whether these imaging features can be used to evaluate treatment response.
Eligible participants are aged 18-80 years with chronic non-specific low back pain lasting more than 3 months, NRS/VAS pain score ≥1, and abnormal baseline ultrasound findings of the lumbar multifidus muscle. All participants will receive a 12-week home-based rehabilitation program, including prone multifidus activation exercises and core stability training, 3-5 times per week, 20-30 minutes each session.
The primary outcome measures are changes in multifidus muscle area, ultrasound imaging features and pain scores after training. Safety will be monitored throughout the study. Training will be adjusted or paused if participants have increased pain, new radiating leg symptoms, dizziness, chest tightness, palpitations, or other adverse conditions.
Read the detailed description
Background: Chronic non-specific low back pain is common, and lumbar multifidus injury or dysfunction is closely associated with this condition. Ultrasound imaging can visualize the morphological features of the multifidus muscle. Radiomics analysis may extract quantitative imaging biomarkers to objectively assess muscle changes after rehabilitation. This study aims to investigate the feasibility of ultrasound radiomics for evaluating rehabilitation treatment effects.
Methods: This is a prospective, single-center interventional trial. Patients aged 18-80 years diagnosed with chronic non-specific low back pain (≥3 months) with NRS/VAS ≥1 and abnormal multifidus ultrasound findings will be enrolled. Subjects will perform 12 weeks of home rehabilitation training: prone multifidus local activation and core stability exercises, 3-5 times weekly, 20-30 minutes per session.
Primary endpoints include changes in multifidus muscle area, ultrasound radiomic features and pain scores after intervention. Secondary objective is to analyze correlations between changes in multifidus ultrasound parameters and improvements in pain and physical function.
Safety monitoring: Training will be modified or suspended if pain increases by ≥2 points compared with baseline and persists, new or worsening radiating pain, numbness or weakness in lower extremities occurs, or participants develop obvious dizziness, chest tightness or palpitations. Investigators will assess risks and decide whether to continue training. All adverse events will be recorded and evaluated.
- Being tested
- Lumbar multifidus muscle rehabilitation exercise
- Keywords
- Low back pain, Lumbar multifidus muscle, Rehabilitation exercise, Ultrasound radiomics, Muscle injury
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbar multifidus muscle rehabilitation exerciseBehavioural
12-week home-based targeted rehabilitation exercise program for lumbar multifidus muscle. Participants complete prescribed exercise at home following guidance.
| Study group | Role | What they receive |
|---|---|---|
| Rehabilitation Exercise Intervention Arm | Experimental | Participants receive a 12-week home-based rehabilitation exercise program targeting lumbar multifidus muscle. Baseline and post-intervention ultrasound examination, ultrasound radiomics analysis and pain function assessment will be performed. Receives: Behavioral: Lumbar multifidus muscle rehabilitation exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cross-sectional area of lumbar multifidus muscle measured by ultrasound
The cross-sectional area of lumbar multifidus muscle will be measured by B-mode ultrasound. The difference between baseline and post-intervention value will be calculated to evaluate the morphological change of lumbar multifidus muscle after 12-week rehabilitation exercise.
Measured: Baseline and 12 weeks after intervention
Secondary outcomes (3)
Change in Visual Analog Scale (VAS) pain score
Visual Analog Scale (VAS, 0-10 points) will be used to assess low back pain intensity. Higher score indicates more severe pain. Change from baseline will be evaluated after 12 weeks of exercise intervention.
Measured: Baseline and 12 weeks after intervention
Change in Oswestry Disability Index (ODI)
Oswestry Disability Index (0-100%) will be applied to evaluate functional disability caused by low back pain. Higher percentage represents greater functional impairment. The change from baseline will be assessed at 12 weeks.
Measured: Baseline and 12 weeks after intervention
Change in ultrasound radiomics features of lumbar multifidus muscle
Quantitative radiomics features (texture, histogram features) extracted from lumbar multifidus ultrasound images will be analyzed to reflect muscle tissue characteristics before and after 12-week rehabilitation training.
Measured: Baseline and 12 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Non-specific Low Back Pain With Lumbar Multifidus Muscle Injury or DysfunctionStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group prospective interventional study. All enrolled participants receive a 12-week home rehabilitation training program for lumbar multifidus muscle. Ultrasound radiomics features and clinical pain function outcomes are measured at baseline and after intervention to explore the feasibility of ultrasound radiomics for treatment effect evaluation.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mingbo Zhang, Chinese PLA General Hospital
- Investigators
- Mingbo Zhang, MD, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07892846
- Sponsor's protocol ID
- PLAGH-2026-002
- Status last verified
- Oct 2026
- First submitted
- 18 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared publicly due to patient privacy protection and institutional data management requirements.
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Therapeutic Effect Evaluation System for Multifidus Muscle Injury in the Lumbar Region Was Constructed Based on Ultrasound Radiomics
- ClinicalTrials.gov ID
- NCT07892846
- Acronym / sponsor ID
- PLAGH-2026-002
- Keywords
- Low back pain, Lumbar multifidus muscle, Rehabilitation exercise, Ultrasound radiomics, Muscle injury
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 23 Oct 2026 (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.
This is a single-center, prospective interventional study. The main purpose is to use ultrasound radiomics to analyze changes in multifidus muscle ultrasound imaging features before and after rehabilitation therapy in patients with low back pain related to lumbar multifidus injury, and explore whether these imaging features can be used to evaluate treatment response.
Eligible participants are aged 18-80 years with chronic non-specific low back pain lasting more than 3 months, NRS/VAS pain score ≥1, and abnormal baseline ultrasound findings of the lumbar multifidus muscle. All participants will receive a 12-week home-based rehabilitation program, including prone multifidus activation exercises and core stability training, 3-5 times per week, 20-30 minutes each session.
The primary outcome measures are changes in multifidus muscle area, ultrasound imaging features and pain scores after training. Safety will be monitored throughout the study. Training will be adjusted or paused if participants have increased pain, new radiating leg symptoms, dizziness, chest tightness, palpitations, or other adverse conditions.
Detailed description
Background: Chronic non-specific low back pain is common, and lumbar multifidus injury or dysfunction is closely associated with this condition. Ultrasound imaging can visualize the morphological features of the multifidus muscle. Radiomics analysis may extract quantitative imaging biomarkers to objectively assess muscle changes after rehabilitation. This study aims to investigate the feasibility of ultrasound radiomics for evaluating rehabilitation treatment effects.
Methods: This is a prospective, single-center interventional trial. Patients aged 18-80 years diagnosed with chronic non-specific low back pain (≥3 months) with NRS/VAS ≥1 and abnormal multifidus ultrasound findings will be enrolled. Subjects will perform 12 weeks of home rehabilitation training: prone multifidus local activation and core stability exercises, 3-5 times weekly, 20-30 minutes per session.
Primary endpoints include changes in multifidus muscle area, ultrasound radiomic features and pain scores after intervention. Secondary objective is to analyze correlations between changes in multifidus ultrasound parameters and improvements in pain and physical function.
Safety monitoring: Training will be modified or suspended if pain increases by ≥2 points compared with baseline and persists, new or worsening radiating pain, numbness or weakness in lower extremities occurs, or participants develop obvious dizziness, chest tightness or palpitations. Investigators will assess risks and decide whether to continue training. All adverse events will be recorded and evaluated.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group prospective interventional study. All enrolled participants receive a 12-week home rehabilitation training program for lumbar multifidus muscle. Ultrasound radiomics features and clinical pain function outcomes are measured at baseline and after intervention to explore the feasibility of ultrasound radiomics for treatment effect evaluation.
| Arm | Type | Receives |
|---|---|---|
| Rehabilitation Exercise Intervention Arm | Experimental | Behavioral: Lumbar multifidus muscle rehabilitation exerciseParticipants receive a 12-week home-based rehabilitation exercise program targeting lumbar multifidus muscle. Baseline and post-intervention ultrasound examination, ultrasound radiomics analysis and pain function assessment will be performed. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 18-80 years old, no restriction on gender.
- Diagnosed with non-specific low back pain with disease duration ≥ 3 months.
- Numerical Rating Scale (NRS) / Visual Analog Scale (VAS) pain score ≥ 1 point.
- Clinically suspected lumbar multifidus muscle injury or dysfunction, with at least one abnormal finding of lumbar multifidus muscle on baseline ultrasound examination, including reduced resting thickness, left-right asymmetry, decreased cross-sectional area or increased echogenicity.
- Able to understand the research content and voluntarily sign the informed consent form.
Key exclusion criteria (10 listed)
- Presence of specific causes of low back pain, such as lumbar infection, tumor, fracture, inflammatory spondyloarthropathy, etc.
- Obvious nerve root compression symptoms, cauda equina syndrome or progressive neurological deficits.
- Previous history of lumbar spine surgery.
- Severe lumbar spondylolisthesis, severe spinal stenosis, severe osteoporosis or other conditions unsuitable for rehabilitation training.
- Complicated with severe cardiopulmonary disease, malignant tumor, systemic infection or other diseases intolerant to training.
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 |
|---|---|---|
| Lumbar multifidus muscle rehabilitation exercise12-week home-based targeted rehabilitation exercise program for lumbar multifidus muscle. Participants complete prescribed exercise at home following guidance. | Behavioural | Rehabilitation Exercise Intervention Arm |
Primary outcome
Change in cross-sectional area of lumbar multifidus muscle measured by ultrasound
Time frame: Baseline and 12 weeks after intervention
The cross-sectional area of lumbar multifidus muscle will be measured by B-mode ultrasound. The difference between baseline and post-intervention value will be calculated to evaluate the morphological change of lumbar multifidus muscle after 12-week rehabilitation exercise.
3 secondary outcomes
Change in Visual Analog Scale (VAS) pain score
Time frame: Baseline and 12 weeks after intervention
Change in Oswestry Disability Index (ODI)
Time frame: Baseline and 12 weeks after intervention
Change in ultrasound radiomics features of lumbar multifidus muscle
Time frame: Baseline and 12 weeks after intervention
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 23 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared publicly due to patient privacy protection and institutional data management requirements.
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.
Mingbo Zhang, MD principal investigator
Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lumbar multifidus muscle rehabilitation exercise in people with Chronic Non-specific Low Back Pain With Lumbar Multifidus Muscle Injury or Dysfunction, run by Chinese PLA General Hospital at 1 site in China.
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 6 inclusion and 10 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: opening soon, as of the sponsor's last update on 23 Oct 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 China. 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?
Contact Mingbo Zhang, MD (+8613552744805, owsifanduizhe@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cross-sectional area of lumbar multifidus muscle measured by ultrasound (time frame: Baseline and 12 weeks after intervention). 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 23 Oct 2026.