An interventional study of Lumbar multifidus muscle rehabilitation exercise in Chronic Non-specific Low Back Pain With Lumbar Multifidus Muscle Injury or Dysfunction, sponsored by Chinese PLA General Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Chinese PLA General Hospital · Not applicable, Interventional, and Other
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.
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.
2,875 studies on the registry are indexed under Low Back Pain; 484 are open to participants now.
This study's planned enrollment of 40 is below the median of 60 across 2,315 interventional studies indexed under Low Back Pain.
Browse Low Back Pain studies →Chinese PLA General Hospital is the lead sponsor of 568 studies on the registry; 205 are open to participants now.
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Exclusion Criteria:
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
12-week home-based targeted rehabilitation exercise program for lumbar multifidus muscle. Participants complete prescribed exercise at home following guidance.
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.
Time frame: Baseline and 12 weeks after intervention
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and 12 weeks after intervention
Plan to share: No — Individual participant data will not be shared publicly due to patient privacy protection and institutional data management requirements.
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for May 2027, 7 months later.
Of 1,187 non-industry interventional studies with no phase under Low Back Pain, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 26. This study's planned 7 months is below that.
Counting every sponsor, half of 1,246 studies reached it within 11 months; a quarter within 5 and three quarters within 26.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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