Spinal cord stimulation for chronic intractable trunk or limb pain: study protocol for a Chinese multicenter randomized withdrawal trial (CITRIP study)

被引：6

作者：

Lu, Yang ^{[1
,2
]}

Mao, Peng ^{[3
]}

Wang, Guihuai ^{[1
]}

Tao, Wei ^{[4
]}

Xiong, Donglin ^{[5
]}

Ma, Ke ^{[6
]}

Li, Rongchun ^{[7
]}

Feng, Dan ^{[8
]}

Duan, Wanru ^{[9
]}

Li, Shun ^{[10
]}

Fu, Zhijian ^{[11
]}

Feng, Zhiying ^{[12
]}

Jin, Yi ^{[13
]}

Wan, Li ^{[14
]}

Lu, Yan ^{[15
]}

Zhang, Daying ^{[16
]}

Fan, Bifa ^{[3
]}

Wang, James Jin ^{[1
]}

Li, Luming ^{[2
]}

机构：

[1] Tsinghua Univ, Beijing Tsinghua Changgung Hosp, Sch Clin Med, Dept Neurosurg, Beijing, Peoples R China

[2] Tsinghua Univ, Sch Aerosp Engn, Natl Engn Lab Neuromodulat, Beijing, Peoples R China

[3] China Japan Friendship Hosp, Dept Pain Med, Beijing, Peoples R China

[4] Shenzhen Univ, Dept Neurosurg, Gen Hosp, Shenzhen, Peoples R China

[5] Huazhong Univ Sci & Technol, Dept Pain Med, Union Shenzhen Hosp, Shenzhen, Peoples R China

[6] Shanghai Jiao Tong Univ, Xinhua Hosp, Dept Algol, Sch Med, Shanghai, Peoples R China

[7] Huazhong Univ Sci & Technol, Wuhan Puai Hosp, Tongji Med Coll, Dept Pain Management, Wuhan, Peoples R China

[8] Wuhan 1 Hosp, Dept Pain Management, Wuhan, Peoples R China

[9] Capital Med Univ, Xuanwu Hosp, Dept Neurosurg, Beijing, Peoples R China

[10] Hangzhou Med Coll, Zhejiang Prov Peoples Hosp, Dept Pain, Peoples Hosp, Hangzhou, Peoples R China

[11] Shandong Univ, Dept Pain Management, Shandong Prov Hosp, Jinan, Peoples R China

[12] Zhejiang Univ, Dept Pain Med, Affiliated Hosp 1, Med Sch, Hangzhou, Peoples R China

[13] Nanjing Jinling Hosp, Dept Anesthesiol, Nanjing, Peoples R China

[14] Guangzhou Med Univ, Dept Pain Management, Affiliated Hosp 2, Guangzhou, Peoples R China

[15] Fourth Mil Med Univ, Xijing Hosp, Dept Pain Med, Xian, Peoples R China

[16] Nanchang Univ, Dept Pain Med, Affiliated Hosp 1, Nanchang, Jiangxi, Peoples R China

来源：

TRIALS | 2020年 / 21卷 / 01期

基金：

中国国家自然科学基金;

关键词：

Chronic intractable pain; Spinal cord stimulation; Efficacy; Safety; Randomized controlled trial; CLINICALLY SIGNIFICANT DIFFERENCE; 10-KHZ HIGH-FREQUENCY; ANALOG SCALE PAIN; ENRICHED ENROLLMENT; CHRONIC BACK; EFFICACY; TOLERABILITY; TELEMEDICINE; OUTCOMES; HEALTH;

D O I：

10.1186/s13063-020-04768-3

中图分类号：

R-3 [医学研究方法]; R3 [基础医学];

学科分类号：

1001 ;

摘要：

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

引用

页数：10

共 38 条

[1] The Past, Present, and Future of Telemedicine for Parkinson's Disease [J].

Achey, Meredith ;

Aldred, Jason L. ;

Aljehani, Noha ;

Bloem, Bastiaan R. ;

Biglan, Kevin M. ;

Chan, Piu ;

Cubo, Esther ;

Dorsey, E. Ray ;

Goetz, Christopher G. ;

Guttman, Mark ;

Hassan, Anhar ;

Khandhar, Suketu M. ;

Mari, Zoltan ;

Spindler, Meredith ;

Tanner, Caroline M. ;

van den Haak, Pieter ;

Walker, Richard ;

Wilkinson, Jayne R. .

MOVEMENT DISORDERS, 2014, 29 (07) :871-883

[2]

BECK AT, 1984, J CLIN PSYCHOL, V40, P1365, DOI 10.1002/1097-4679(198411)40:6<1365::AID-JCLP2270400615>3.0.CO

[3]

2-D

[4] Optimal Strategies for Reporting Pain in Clinical Trials and Systematic Reviews: Recommendations from an OMERACT 12 Workshop [J].

Busse, Jason W. ;

Bartlett, Susan J. ;

Dougados, Maxime ;

Johnston, Bradley C. ;

Guyatt, Gordon H. ;

Kirwan, John R. ;

Kwoh, Kent ;

Maxwell, Lara J. ;

Moore, Andrew ;

Singh, Jasvinder A. ;

Stevens, Randall ;

Strand, Vibeke ;

Suarez-Almazor, Maria E. ;

Tugwell, Peter ;

Wells, George A. .

JOURNAL OF RHEUMATOLOGY, 2015, 42 (10) :1962-1970

[5] Burst Spinal Cord Stimulation: Review of Preclinical Studies and Comments on Clinical Outcomes [J].

Chakravarthy, Krishnan ;

Kent, Alexander R. ;

Raza, Adil ;

Xing, Fang ;

Kinfe, Thomas M. .

NEUROMODULATION, 2018, 21 (05) :431-439

[6] Spinal Cord Stimulation for Treating Chronic Pain: Reviewing Preclinical and Clinical Data on Paresthesia-Free High-Frequency Therapy [J].

Chakravarthy, Krishnan ;

Richter, Hira ;

Christo, Paul J. ;

Williams, Kayode ;

Guan, Yun .

NEUROMODULATION, 2018, 21 (01) :10-18

[7]

Chen Y, 2015, IEEE ENG MED BIO, P186, DOI 10.1109/EMBC.2015.7318331

[8]

Chen Y, 2014, IEEE ENG MED BIO, P1358, DOI 10.1109/EMBC.2014.6943851

[9] Association of specialist involvement and quality of care for Parkinson's disease [J].

Cheng, Eric M. ;

Swarztrauber, Kari ;

Siderowf, Andrew D. ;

Eisa, Mahmood S. ;

Lee, Martin ;

Vassar, Stefanie ;

Jacob, Erin ;

Vickrey, Barbara G. .

MOVEMENT DISORDERS, 2007, 22 (04) :515-522

[10] A Systematic Literature Review of Spine Neurostimulation Therapies for the Treatment of Pain [J].

Deer, Timothy R. ;

Grider, Jay S. ;

Lamer, Tim J. ;

Pope, Jason E. ;

Falowski, Steven ;

Hunter, Corey W. ;

Provenzano, David A. ;

Slavin, Konstantin, V ;

Russo, Marc ;

Carayannopoulos, Alexios ;

Shah, Jay M. ;

Harned, Michael E. ;

Hagedorn, Jonathan M. ;

Bolash, Robert B. ;

Arle, Jeff E. ;

Kapural, Leo ;

Amirdelfan, Kasra ;

Jain, Sameer ;

Liem, Liong ;

Carlson, Jonathan D. ;

Malinowski, Mark N. ;

Bendel, Markus ;

Yang, Ajax ;

Aiyer, Rohit ;

Valimahomed, Ali ;

Antony, Ajay ;

Craig, Justin ;

Fishman, Michael A. ;

Al-Kaisy, Adnan A. ;

Christelis, Nick ;

Rosenquist, Richard W. ;

Levy, Robert M. ;

Mekhail, Nagy .

PAIN MEDICINE, 2020, 21 (07) :1421-1432

← 1 2 3 4 →