Osteoporosis
Conditions
Interventions
Extracorporeal shock wave therapy (ESWT) will be performed once during the spinal surgery using the Duolith SD1 Ultra device manufactured by Karl Storz Endoscopy Japan Co., Ltd. The energy level will
ESWT
Sponsors
Chikuda Hirotaka
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients aged 50 years and over. 2) Patients diagnosed with osteoporosis. 3) Patients diagnosed with spinal disorders based on imaging studies and clinical symptoms, for whom surgery has been recommended by a surgeon. 4) Patients with a performance status (PS) of 0-1. 5) Inpatients. 6) Patients who have provided written informed consent to participate in this study.
Exclusion criteria
Exclusion criteria: 1) Patients with a muscle strength grade of less than 4 (MMT < 4) on preoperative neurological examination. 2) Patients deemed to have cognitive impairment by a surgeon. 3) Patients with untreated bleeding disorders such as hemophilia or those taking anticoagulants. 4) Patients with a history of thromboembolic disease. 5) Patients with malignant tumors or neural/cauda equina tumors in or near the irradiation field. 6) Patients with implanted pacemakers. 7) Patients deemed unsuitable for the study by the surgeon.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intraoperative neurophysiological monitoring will be performed to assess motor evoked potentials (MEPs). A neurophysiologist will determine if there is a decrease in MEP amplitude of more than 50% compared to the baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes from baseline in the following evaluation items Somatosensory Evoked Potential (SEP) Numerical Rating Scale (NRS) Physical examination findings (Manual Muscle Testing (MMT), dermatomes of pain and numbness, presence or absence of bladder and bowel dysfunction) Occurrence of adverse events | — |
Contacts
Public ContactEiji Takasawa
Gunma University Hospital
Outcome results
None listed