Study of HBO for CSM

Not Applicable

Recruiting

• Conditions: compressive cervical myelopathy; myelopathy; Spinal Cord Compression

• Registration Number: JPRN-jRCT1062230023
• Lead Sponsor: Takeda Chikako

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-06-16
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Men and women 20 years of age or older at the time consent is obtained
Patients diagnosed with compression cervical myelopathy and undergoing cervical laminoplasty
Patients who are able to make an outpatient visit to our hospital after the surgery
Patients who are able to communicate well

Exclusion Criteria

When decompression is performed at the C1/2 level only
When the compressive lesion is caused by infection or hematoma
Cases of concomitant immobilization
Contraindications to hyperbaric oxygen therapy
Patients with a history of neurological disease
Patients with difficulty in opening the Eustachian tube
Previous trauma to the tympanic membrane or exudative otitis media
Patients after retinal detachment surgery
Patients with skull base fracture or pneumoencephalopathy
Patients who are pregnant or may become pregnant
Other patients deemed inappropriate by the principal investigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of JOA improvement rates

Secondary Outcome Measures

Name	Time	Method
Comparison of JOA scores and changes over time<br>Changes over time in clinical findings and subjective symptoms<br>Complications<br>Comparison of cervical spine alignment and neck pain by VAS<br>MRI findings