Multimodal Exercise Therapy for Non-Surgical Intervention of Nonspecific Low Back Pain. (METNLBP)

January 19, 2026 updated by: Xuanwu Hospital, Beijing

Interventional Study on Paraspinal Muscle Degeneration Leading to Lumbar Degenerative Diseases

This multicenter, assessor-blinded, two-arm parallel randomized controlled trial (N = 314) will compare the efficacy and safety of a 6-week multidimensional exercise program plus usual pharmacological care (experimental arm) versus usual pharmacological care alone (control arm) in adults ≥ 60 years with chronic non-specific low-back pain (LBP) and imaging evidence of paraspinal muscle degeneration. The primary endpoint is change in Oswestry Disability Index (ODI) at 12 months. Secondary endpoints include pain VAS, JOA score, recurrence rate, and patient satisfaction measured repeatedly to 12 months. Advanced MRI radiomics and machine-learning algorithms will be used to build a "paraspinal muscle imaging-function-prognosis" prediction model and an open-access web tool for risk stratification. The study will generate a standardized, evidence-based non-operative care pathway for chronic LBP driven by paraspinal muscle degeneration

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Primary: to determine whether a 6-week supervised home-based multidimensional exercise program (aerobic, strength, balance, flexibility) added to short-term NSAIDs improves 12-month functional outcome (ODI) compared with NSAIDs alone.

Secondary: (1) compare pain intensity, quality of life, recurrence, and safety between arms; (2) develop and validate a radiomics-plus-machine-learning model that uses baseline MRI features of paraspinal muscles, demographic, clinical, and functional variables to predict treatment response and recurrence risk; (3) integrate the validated model with the exercise intervention to create a risk-stratified, early-intervention clinical pathway for chronic LBP.

Study Design：Multicenter, prospective, assessor-blinded, superiority RCT with 1:1 allocation, conducted at 4 tertiary hospitals and 1 academic research center in Beijing. Randomization (block sizes 4 and 6, stratified by center and sex) generated centrally via web-based system; allocation concealed from outcome assessors and statisticians.

Population Inclusion: age ≥ 60 y; LBP ≥ 3 months; ODI 20-60; MRI evidence of paraspinal muscle fatty infiltration ≥ Goutallier grade 2; no surgical indication; able to exercise.

Exclusion: specific spinal pathology (infection, tumor, fracture, severe deformity); previous lumbar surgery; severe comorbidities limiting exercise; cognitive impairment; current participation in another trial.

Interventions Experimental: 6-week multidimensional exercise (5 days/week, 30-40 min) plus 4-week oral NSAIDs (celecoxib or acetaminophen, dose-adjusted). Exercise comprises (1) low-intensity aerobic walking; (2) light-load high-repetition strength training (upper limb, lower limb, core); (3) balance and proprioceptive drills; (4) stretching. Printed manual + training diary; weekly phone/video supervision; compliance algorithm (≥ 75 % overall score required).

Control: same NSAID regimen alone. Both groups receive standardized education booklet on posture and activity pacing.

Outcomes Primary: ODI at 12 months (minimal clinically important difference 10 points). Secondary: VAS pain, JOA score at 1, 3, 6, 12 months; recurrence (≥ 24 h LBP with VAS > 2) within 12 months; patient satisfaction (NASS questionnaire); adverse events; compliance.

Imaging: axial MRI (3 T) at L1-5; semi-automated segmentation (3D-Slicer) to quantify cross-sectional area, fat fraction, radiomic features (shape, first-order, GLCM, GLRLM, GLSZM, GLDM).

Functional: Biering-Sørensen endurance test; surface electromyography of multifidus.

Biomarkers: baseline bloods (CBC, renal, hepatic panels). Sample Size 314 participants (157 per arm) provide 80 % power (α = 0.025 one-sided) to detect 15-point ODI difference (SD 15), allowing 10 % attrition.

Data Analysis

Intention-to-treat primary analysis: ANCOVA adjusted for baseline ODI, sex, center. Secondary longitudinal scores analyzed with mixed-effects models; recurrence with Kaplan-Meier and Cox regression.Radiomics:

7:3 split; 100× bootstrap; LASSO feature selection; multivariable modeling (logistic regression, random forest, XGBoost, LightGBM, MLP); performance reported as AUC, sensitivity, specificity, PPV, NPV, F1; SHAP/LIME for interpretability. Internal 5-fold cross-validation; final model deployed as web calculator.

Quality & Ethics Protocol approved by central ethics committee; registered at Chictr.org.cn. Written informed consent. Data entry via validated EpiData system; double verification; 5-year retention. Adverse events monitored by independent DSMB. Study conducted in accordance with Helsinki Declaration and ICH-GCP.

Study Type

Interventional

Enrollment (Estimated)

314

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100053
        • Xuanwu Hospital,Capital Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥ 60 years
  2. Chronic low-back pain for > 3 months (no surgical indication)
  3. Planned to receive conservative treatment
  4. Willing to participate and able to provide written informed consent

Exclusion Criteria:

  1. Specific low-back pain due to infection, tumour, fracture, ankylosing spondylitis, scoliosis, or other structural spinal disorders
  2. Previous lumbar surgery or current surgical indication for lumbar disease 3.Severe cardiopulmonary, hepatic or renal insufficiency that precludes exercise or drug therapy

4.Severe cognitive impairment or psychiatric disorder preventing cooperation 5.Marked exercise limitations or physical disability precluding rehabilitation training 6.Participation in another clinical trial that could interfere with outcomes 7.Known hypersensitivity to any study medication

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Multidimensional Exercise+Standard Oral Medication
Participants receive a 6-week multidimensional exercise intervention (including aerobic, strength, balance, and flexibility training) combined with standard oral NSAIDs (e.g., ibuprofen or celecoxib) for 4 weeks
Behavioral: Multidimensional exercise intervention
Patients deemed by clinicians as not requiring surgical intervention and who consent to participate in the study will undergo an initial evaluation at the outpatient follow-up clinic. A multidimensional exercise intervention program and oral medication therapy (4 weeks) will be implemented based on the evaluation results.
Active Comparator: Standard Oral Medication Only
Active ComparatorArm Description: Participants receive standard oral NSAIDs (e.g., ibuprofen or celecoxib) for 4 weeks without any structured exercise intervention.
Drug: Oral NSAIDs
Participants receive the same 4-week oral NSAID regimen without structured exercise intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Oswestry Disability Index(ODI) score at 1 year post-treatment
Time Frame: 12 months after randomization
12 months after randomization

Secondary Outcome Measures

Outcome Measure
Time Frame
1.Change in Oswestry Disability Index (ODI) score.
Time Frame: Baseline, end-of-intervention, 1 month, 3 months, 6 months post-intervention
Baseline, end-of-intervention, 1 month, 3 months, 6 months post-intervention
atient satisfaction with treatment(Assessed by the North American Spine Society (NASS) satisfaction questionnaire)
Time Frame: 12 months post-intervention
12 months post-intervention
Change in Visual Analogue Scale (VAS) score for low back pain
Time Frame: Baseline, end-of-intervention, 1 month, 3 months, 6 months post-intervention
Baseline, end-of-intervention, 1 month, 3 months, 6 months post-intervention
Change in Japanese Orthopaedic Association (JOA) score
Time Frame: Baseline, end-of-intervention, 1 month, 3 months, 6 months post-intervention
Baseline, end-of-intervention, 1 month, 3 months, 6 months post-intervention
Recurrence rate of low back pain(Defined as new episode lasting ≥24 h with VAS)
Time Frame: Baseline, end-of-intervention, 1 month, 3 months, 6 months post-intervention
Baseline, end-of-intervention, 1 month, 3 months, 6 months post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xuanwu Hospital, Beijing

Investigators

  • Study Chair: Shibao Lu, MD, Xuanwu Hospital, Beijing
  • Study Director: Xiaolong Chen, MD, Xuanwu Hospital, Beijing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

September 1, 2028

Study Registration Dates

First Submitted

December 29, 2025

First Submitted That Met QC Criteria

January 19, 2026

First Posted (Actual)

January 20, 2026

Study Record Updates

Last Update Posted (Actual)

January 20, 2026

Last Update Submitted That Met QC Criteria

January 19, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • xuanwu_LBP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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