Spinal cord stimulation for chronic intractable trunk or limb pain: study protocol for a Chinese multicenter randomized withdrawal trial (CITRIP study)
Yang Lu,
Peng Mao,
Guihuai Wang,
Wei Tao,
Donglin Xiong,
Ke Ma,
Rongchun Li,
Dan Feng,
Wanru Duan,
Shun Li,
Zhijian Fu,
Zhiying Feng,
Yi Jin,
Li Wan,
Yan Lu,
Daying Zhang,
Bifa Fan,
James Jin Wang,
Luming Li
Affiliations
Yang Lu
Department of Neurosurgery, Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University
Peng Mao
Department of Pain Medicine, China-Japan Friendship Hospital
Guihuai Wang
Department of Neurosurgery, Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University
Wei Tao
Department of Neurosurgery, Shenzhen University General Hospital
Donglin Xiong
Department of Pain Medicine, Huazhong University of Science and Technology of Union Shenzhen Hospital
Ke Ma
Department of Algology, Xinhua Hospital, Shanghai Jiaotong University School of Medicine
Rongchun Li
Department of Pain Management, Wuhan Pu’ai Hospital, Tongji Medical College, Huazhong University of Science and Technology
Dan Feng
Department of Pain Management, Wuhan No. 1 Hospital
Wanru Duan
Department of Neurosurgery, Xuanwu Hospital, Capital Medical University
Shun Li
Department of Pain, Zhejiang Provincial People’s Hospital, People’s Hospital of Hangzhou Medical College
Zhijian Fu
Department of Pain Management, Shandong Provincial Hospital Affiliated to Shandong University
Zhiying Feng
Department of Pain Medicine, The First Affiliated Hospital of Medical School of Zhejiang University
Yi Jin
Department of Anesthesiology, Nanjing Jinling Hospital
Li Wan
Department of Pain Management, The Second Affiliated Hospital of Guangzhou Medical University
Yan Lu
Department of Pain Medicine, Xijing Hospital, Fourth Military Medical University
Daying Zhang
Department of Pain Medicine, The First Affiliated Hospital of Nanchang University
Bifa Fan
Department of Pain Medicine, China-Japan Friendship Hospital
James Jin Wang
Department of Neurosurgery, Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University
Luming Li
National Engineering Laboratory for Neuromodulation, School of Aerospace Engineering, Tsinghua University
Abstract Background 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. Method 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. Discussion 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. Trial registration ClinicalTrials.gov NCT03858790 . Registered on March 1, 2019, retrospectively registered
