The Intervention Effect of Exercise on Lumbar Multifidus Muscle Injuries

NCT07892846 | Not Yet Recruiting

• 1 other identifier: PLAGH-2026-002
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Chronic Non-specific Low Back Pain With Lumbar Multifidus Muscle Injury or Dysfunction

Keywords

Low back pain; Lumbar multifidus muscle; Rehabilitation exercise; Ultrasound radiomics; Muscle injury

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 12 weeks after intervention

Secondary Outcomes (3)

• Change in Visual Analog Scale (VAS) pain score

  Baseline and 12 weeks after intervention

• Change in Oswestry Disability Index (ODI)

  Baseline and 12 weeks after intervention

• Change in ultrasound radiomics features of lumbar multifidus muscle

  Baseline and 12 weeks after intervention

Study Arms (1)

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.

Behavioral: Lumbar multifidus muscle rehabilitation exercise

Interventions

Lumbar multifidus muscle rehabilitation exercise BEHAVIORAL

12-week home-based targeted rehabilitation exercise program for lumbar multifidus muscle. Participants complete prescribed exercise at home following guidance.

Rehabilitation Exercise Intervention Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mingbo Zhang, MD

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mingbo Zhang, MD

CONTACT

+8613552744805; owsifanduizhe@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician, Department of Ultrasound

Model Details: 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.

Study Record Dates

• First Submitted: October 18, 2026
• First Posted: October 23, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: October 23, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)