Multimodal Exercise Therapy for Non-Surgical Intervention of Nonspecific Low Back Pain.
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
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
Treatments tested in this trial
- Multidimensional exercise intervention
- Oral NSAIDs
Treatment groups
314 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov