Osteoporotic vertebral compression fracture (OVCF) occurring at the T12–L1 segment, secondary to osteoporosis.
Conditions
Interventions
Experimental group:General supportive treatment + rehabilitation exercises to strengthen the multifidus muscles
Control group:General supportive care + traditional rehabilitation exercises
Sponsors
Sichuan Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Meets the diagnostic criteria for osteoporotic vertebral compression fractures as per the "Diagnosis and Treatment Guidelines for Osteoporotic Fractures (2022)": The causative factor is non-violent or low-energy injury; 2.Patients with T12-L1 segmental compression fractures; 3.Age >= 50 years old; 4.Within 24 hours after vertebroplasty; 5.Imaging examination shows that the anterior edge of the thoracic vertebrae has compression < 50%, the anterior edge of the lumbar vertebrae has compression < 75%, no destruction of the posterior wall of the vertebrae is observed on CT to rule out pedicle fractures, and the clinical data are complete; 6.Understand the test process, rights and obligations, agree and sign the informed consent form for the subject.
Exclusion criteria
Exclusion criteria: 1.Those with non-osteoporotic fractures (such as traumatic fractures); 2.Those with non-fracture-induced low back pain; 3.Those with severe comorbidities (such as severe cardiac, pulmonary, or neurological disorders, unable to engage in rehabilitation activities); 4.Those with severe disabilities, severe joint and bone diseases that affect the progress and outcome of the trial; 5.Those with severe mental disorders and cognitive impairments and are unable to cooperate in completing the trial; 6.Those with contraindications for MRI; 7.Those currently participating in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Oswestry Disability Index (ODI); | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety evaluation: Adverse events (falls, fracture progression, training-related injuries, etc.);Number of Falls;Therapeutic Efficacy Evaluation (Overall Clinical Response Rate);Scoliosis Research Society-22 Questionnaire (SRS-22);Visual Analogue Scale (VAS);Spinal sagittal parameters(CL?LL?TK?TLK?PrTK?TKmax?PI?SS?PT?SVA?TPA?GK);Multifidus Muscle Morphological Parameters(Fatty Infiltration Index,MF FI?Relative Functional Cross-Sectional Area,MF rFCSA?Relative Gross Cross-Sectional Area,MF rGCSA);Medical Outcomes Study 36-Item Short Form Health Survey (MOS SF-36); | — |
Countries
China
Contacts
Public ContactZhang Yun
Sichuan Provincial People's Hospital
Outcome results
None listed