Spinal cord stimulation for chronic intractable trunk or limb pain: study protocol for a Chinese multicenter randomized withdrawal trial (CITRIP study)
单位：[1]Department of Neurosurgery, Beijing Tsinghua Changgung Hospital, Schoolof Clinical Medicine, Tsinghua University, Beijing, China[2]NationalEngineering Laboratory for Neuromodulation, School of AerospaceEngineering, Tsinghua University, Beijing, China[3]Department of PainMedicine, China-Japan Friendship Hospital, Beijing, China[4]Department ofNeurosurgery, Shenzhen University General Hospital, Shenzhen, China深圳大学总医院深圳市康宁医院深圳医学信息中心[5]Department of Pain Medicine, Huazhong University of Science andTechnology of Union Shenzhen Hospital, Shenzhen, China深圳市康宁医院深圳市南山区人民医院深圳医学信息中心[6]Department ofAlgology, Xinhua Hospital, Shanghai Jiaotong University School of Medicine,Shanghai, China[7]Department of Pain Management, Wuhan Pu’ai Hospital,Tongji Medical College, Huazhong University of Science and Technology,Wuhan, China[8]Department of Pain Management, Wuhan No.1 Hospital,Wuhan, China[9]Department of Neurosurgery, Xuanwu Hospital, CapitalMedical University, Beijing, China首都医科大学宣武医院[10]Department of Pain, Zhejiang ProvincialPeople’s Hospital, People’s Hospital of Hangzhou Medical College, Hangzhou,China[11]Department of Pain Management, Shandong Provincial HospitalAffiliated to Shandong University, Jinan, China[12]Department of PainMedicine, The First Affiliated Hospital of Medical School of ZhejiangUniversity, Hangzhou, China[13]Department of Anesthesiology, NanjingJinling Hospital, Nanjing, China[14]Department of Pain Management, TheSecond Affiliated Hospital of Guangzhou Medical University, Guangzhou,China[15]Department of Pain Medicine, Xijing Hospital, Fourth MilitaryMedical University, Xi’an, China[16]Department of Pain Medicine, The FirstAffiliated Hospital of Nanchang University, Nanchang, China
BackgroundAlthough effective results of many studies support the use of spinal cord stimulation in chronic pain patients, no randomized controlled trial has been undertaken in China to date. CITRIP is a multicenter, prospective, randomized, withdrawal study designed to evaluate the clinical effectiveness and safety of spinal cord stimulation plus remote programming management in patients with intractable trunk or limb pain.MethodParticipants will be recruited in approximately 10 centers across China. Eligible participants with intractable trunk or limb and an average visual analog scale (VAS) score >= 5 will undergo a spinal cord stimulation test. Participants with VAS score reduction >= 50% could move forward to receive implantation of an implanted pulse generator. In the withdrawal period at 3-month follow-up visit, participants randomized to the experimental group (EG) will undergo continuous stimulation while ceasing the stimulation in the control group (CG). The outcome assessment will occur at baseline and at 1, 3 (pre- and post-randomization), and 6months. The primary outcome is the difference of maximal VAS score between EG and CG in the withdrawal period compared with baseline before the withdrawal period. Additional outcomes include VAS score change at 1-, 3-, and 6-month follow-ups; responder rate (VAS score improving by 50%); achievement rate of a desirable pain state (VAS score <= 4); awake times during sleep; Beck Depression Inventory for depression evaluation; short-form 36 for quality of life evaluation; drug usage; and satisfaction rating of the device. Adverse events will be collected. The primary analysis will follow the intention-to-treat principle.DiscussionThe CITRIP study seeks to evaluate the effectiveness and safety of a randomized withdrawal trial of spinal cord stimulation for patients with intractable trunk or limb pain.Trial registrationClinicalTrials.gov NCT03858790. Registered on March 1, 2019, retrospectively registered
基金：
National Key Research and Development Program of China [2016YFC0105502]; National Natural Science Foundation of ChinaNational Natural Science Foundation of China (NSFC) [81527901]; Beijing New-star Plan of Science and Technology Program [Z181100006218129]
第一作者单位：[1]Department of Neurosurgery, Beijing Tsinghua Changgung Hospital, Schoolof Clinical Medicine, Tsinghua University, Beijing, China[2]NationalEngineering Laboratory for Neuromodulation, School of AerospaceEngineering, Tsinghua University, Beijing, China
共同第一作者：
通讯作者：
推荐引用方式(GB/T 7714)：
Lu Yang,Mao Peng,Wang Guihuai,et al.Spinal cord stimulation for chronic intractable trunk or limb pain: study protocol for a Chinese multicenter randomized withdrawal trial (CITRIP study)[J].TRIALS.2020,21(1):doi:10.1186/s13063-020-04768-3.
APA：
Lu Yang,Mao Peng,Wang Guihuai,Tao Wei,Xiong Donglin...&Li Luming.(2020).Spinal cord stimulation for chronic intractable trunk or limb pain: study protocol for a Chinese multicenter randomized withdrawal trial (CITRIP study).TRIALS,21,(1)
MLA：
Lu Yang,et al."Spinal cord stimulation for chronic intractable trunk or limb pain: study protocol for a Chinese multicenter randomized withdrawal trial (CITRIP study)".TRIALS 21..1(2020)
