Health TrialsbyHealthPanel

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

ConditionsParaspinal MusclesLow Back PainMachine LearningRadiomicsNon-surgical Treatment
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorXuanwu Hospital, Beijing

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 60 years

Chronic low-back pain for > 3 months (no surgical indication)

Planned to receive conservative treatment

Willing to participate and able to provide written informed consent

Disqualifiers

Specific low-back pain due to infection, tumour, fracture, ankylosing spondylitis, scoliosis, or other structural spinal disorders

Previous lumbar surgery or current surgical indication for lumbar disease 3.Severe cardiopulmonary, hepatic or renal insufficiency that precludes exercise or drug therapy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Multidimensional exercise intervention

    Behavioral

    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.

  • Oral NSAIDs

    Drug

    Participants receive the same 4-week oral NSAID regimen without structured exercise intervention

Treatment groups

314 Participants
are divided into 2 treatment groups
Group A: Multidimensional Exercise+Standard Oral MedicationExperimental treatment 1 intervention
Group B: Standard Oral Medication OnlyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Oswestry Disability Index(ODI) score at 1 year post-treatment

Time frame
12 months after randomization

Secondary outcomes

1

1.Change in Oswestry Disability Index (ODI) score.

Time frame
Baseline, end-of-intervention, 1 month, 3 months, 6 months post-intervention
2

atient satisfaction with treatment(Assessed by the North American Spine Society (NASS) satisfaction questionnaire)

Time frame
12 months post-intervention
3

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
4

Change in Japanese Orthopaedic Association (JOA) score

Time frame
Baseline, end-of-intervention, 1 month, 3 months, 6 months post-intervention

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xuanwu Hospital, Beijing

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: