Safety assessment of extracorporeal shock wave therapy in patients with osteoporotic spine

JRCT ID: jRCTs032240657

Registered date:03/02/2025

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Osteoporosis
• Date of first enrollment: 03/02/2025
• Target sample size: 4
• Study type: Interventional
• Intervention(s): 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 be set at either 0.15 or 0.25 mJ/mm2, and the number of impulses will be 2000.

Outcome(s)

• Primary Outcome: 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 Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 50age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Chikuda Hirotaka