Spinal cord stimulation for chronic intractable trunk or limb pain: study protocol for a Chinese multicenter randomized withdrawal trial (CITRIP study).
机构：[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[5]Department of Pain Medicine, Huazhong University of Science andTechnology of Union Shenzhen Hospital, Shenzhen, China[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[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
Although 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.
Participants 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 6 months. 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.
The 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.
ClinicalTrials.gov NCT03858790 . Registered on March 1, 2019, retrospectively registered.
基金：
The National Key Research and Development
Program of China (2016YFC0105502), National Natural Science Foundation of
China (81527901), and Beijing New-star Plan of Science and Technology Program
(Z181100006218129).
第一作者机构：[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
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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)
