臨床研究等提出・公開システム

Japanese

Date of registration	April. 22, 2026
Last modified on	April. 22, 2026
Trial ID	jRCT1030260077

Scientific Title	Remote Ischemic Preconditioning to Improve Postoperative Recovery After Posterior Cervical Decompression for Cervical Spondylotic Myelopathy: A Multicenter, Randomized, Double-Blind, Sham-Controlled Trial (RIPCORD-CSM trial)
Public Title	A study of remote ischemic preconditioning during surgery to improve recovery after posterior cervical decompression for cervical spondylotic myelopathy (RIPCORD-CSM)

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

Recruitment status	Recruiting

Anticipated date of first enrollment		April. 22, 2026
Target sample size		100
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion 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
	Exclusion 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
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Cervical spondylotic myelopathy
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.
Health Condition(s) Keyword		cervical spondylotic myelopathy, cervical myelopathy, degenerative cervical disease
Intervention(s) Keyword		remote ischemic preconditioning, RIPC, tourniquet, sham procedure
Health Condition(s) Code		M47.12
Primary Outcome(s)		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(s)		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)

Name of Certified Review Board	The Ethical Committee for Medical and Biological Research of Shinshu University School of Medicine
Address	Asashi 3-1-1, Matsumoto, Nagano, Nagano
Telephone	+81-263-37-3099
E-Mail	mdrinri@shinshu-u.ac.jp
Approval Status	Approval
Date of approval	April. 13, 2026

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none