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JAPANESE
JRCT ID: jRCT1030260077

Registered date:22/04/2026

A study of remote ischemic preconditioning during surgery to improve recovery after posterior cervical decompression for cervical spondylotic myelopathy

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedCervical spondylotic myelopathy
Date of first enrollment22/04/2026
Target sample size100
Countries of recruitment
Study typeInterventional
Intervention(s)RIPC using a lower-limb tourniquet after induction of general anesthesia. In the RIPC group, the cuff is inflated to systolic blood pressure +130 mmHg for 5 minutes followed by 5 minutes of deflation for 5 cycles. In the sham group, cuff inflation is set at 20 mmHg with the same schedule during posterior cervical decompression surgery.

Outcome(s)

Primary OutcomeJOA recovery rate at 3, 6, and 12 months after surgery JOA recovery rate (%) = (postoperative JOA score - preoperative JOA score) / (17 - preoperative JOA score) x 100
Secondary Outcome1) Incidence of postoperative C5 palsy (a decrease of >=2 grades in manual muscle testing of C5-innervated muscles [deltoid and biceps] compared with preoperative status) 2) JOACMEQ at 3, 6, 12, and 24 months after surgery 3) EQ-5D at 3, 6, 12, and 24 months after surgery 4) Intraoperative and postoperative complications (including infection, reoperation, and deep vein thrombosis) 5) RIPC-related local adverse events (including skin injury and pain)

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximumNot applicable
GenderBoth
Include criteria1) Age 18 years or older at the time of informed consent 2) Diagnosed with cervical spondylotic myelopathy based on clinical and imaging findings 3) Scheduled to undergo posterior cervical decompression surgery 4) Written informed consent obtained from the participant
Exclude criteria1) Previous surgery at the same level, combined anterior surgery, or concomitant spinal surgery at another site 2) Emergency surgery or insufficient time to perform the RIPC procedure 3) Contraindications to RIPC, including severe soft tissue injury, fracture or vascular injury, or peripheral vascular disease 4) Severe cardiopulmonary, hepatic, or renal dysfunction, severe coagulopathy, pregnancy, or breastfeeding 5) Expected poor follow-up adherence or poor treatment compliance 6) Considered inappropriate for study participation by the principal investigator

Related Information

Contact

Public contact
Name Tetsuhiko Mimura
Address Asahi 3-1-1, Matsumoto, Nagano Nagano Japan 3908621
Telephone +81-263372659
E-mail tettim3@yahoo.co.jp
Affiliation Shinshu University Hospital
Scientific contact
Name Tetsuhiko Mimura
Address Asahi 3-1-1, Matsumoto, Nagano Nagano Japan 3908621
Telephone +81-263372659
E-mail tettim3@yahoo.co.jp
Affiliation Shinshu University Hospital