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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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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

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.

Mingbo Zhang, MD contact

+8613552744805

owsifanduizhe@126.com

China1 site

Chinese PLA General Hospital
Beijing, Beijing Municipality
Mingbo Zhang, MD, +8613552744805, owsifanduizhe@126.com

Other trials in China

About this study

Official title: A Therapeutic Effect Evaluation System for Multifidus Muscle Injury in the Lumbar Region Was Constructed Based on Ultrasound Radiomics

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.

Conditions: Chronic Non-specific Low Back Pain With Lumbar Multifidus Muscle Injury or Dysfunction
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 groups in NCT07892846
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.

Oct 2026May 2027

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)

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.