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

NCT07353372 | Not Yet Recruiting

• 1 other identifier: xuanwu_LBP
• Study Type: interventional
• Target: 314
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Paraspinal Muscles; Low Back Pain; Machine Learning; Radiomics; Non-surgical Treatment

Keywords

Nonsteroidal anti-inflammatory drugs; Multidimensional exercise intervention

Outcome Measures

Primary Outcomes (1)

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

  12 months after randomization

Secondary Outcomes (5)

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

  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)

  12 months post-intervention

• Change in Visual Analogue Scale (VAS) score for low back pain

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

• Change in Japanese Orthopaedic Association (JOA) score

  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)

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

Study Arms (2)

Multidimensional Exercise+Standard Oral Medication

EXPERIMENTAL

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

Standard Oral Medication Only

ACTIVE COMPARATOR

Active ComparatorArm Description: Participants receive standard oral NSAIDs (e.g., ibuprofen or celecoxib) for 4 weeks without any structured exercise intervention.

Drug: Oral NSAIDs

Interventions

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.

Multidimensional Exercise+Standard Oral Medication

Oral NSAIDs DRUG

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

Standard Oral Medication Only

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital,Capital Medical University

Beijing, Beijing Municipality, 100053, China

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Anti-Inflammatory Agents, Non-Steroidal

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Anti-Inflammatory Agents; Therapeutic Uses; Antirheumatic Agents

Study Officials

• Shibao Lu, MD

  Xuanwu Hospital, Beijing

  STUDY CHAIR

• Xiaolong Chen, MD

  Xuanwu Hospital, Beijing

  STUDY DIRECTOR

Central Study Contacts

Xiaolong Chen, MD

CONTACT

+8613811839409; chensmalldragon@163.com

Dongfan Wang, MD

CONTACT

+8618210728213; wdfdoctor@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2025
• First Posted: January 20, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: January 20, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)