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) studied | Cervical spondylotic myelopathy |
| Date of first enrollment | 22/04/2026 |
| Target sample size | 100 |
| Countries of recruitment | |
| Study type | Interventional |
| 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 Outcome | JOA 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 Outcome | 1) 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 maximum | Not applicable |
| Gender | Both |
| Include criteria | 1) 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 criteria | 1) 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
| Primary Sponsor | Mimura Tetsuhiko |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | |
| Secondary ID(s) |
Contact
| Public contact | |
| Name | Tetsuhiko Mimura |
| Address | Asahi 3-1-1, Matsumoto, Nagano Nagano Japan 3908621 |
| Telephone | +81-263372659 |
| 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 |
| tettim3@yahoo.co.jp | |
| Affiliation | Shinshu University Hospital |