Study of HBO for CSM

JRCT ID: jRCT1062230023

Registered date:16/06/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: compressive cervical myelopathy
• Date of first enrollment: 31/05/2023
• Target sample size: 40
• Study type: Interventional
• Intervention(s): Hyperbaric oxygen therapy once a day for 10 times after surgery

Outcome(s)

• Primary Outcome: Comparison of JOA improvement rates

Secondary Outcome

Comparison of JOA scores and changes over time
Changes over time in clinical findings and subjective symptoms
Complications
Comparison of cervical spine alignment and neck pain by VAS
MRI findings

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Takeda Chikako