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Trials
Published in: Trials 1/2020

Open Access 01-12-2020 | Spinal Cord Stimulation | Study protocol

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

Authors: 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

Published in: Trials | Issue 1/2020

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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
Appendix
Available only for authorised users
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Metadata
Title
Spinal cord stimulation for chronic intractable trunk or limb pain: study protocol for a Chinese multicenter randomized withdrawal trial (CITRIP study)
Authors
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
Publication date
01-12-2020
Publisher
BioMed Central
Published in
Trials / Issue 1/2020
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-020-04768-3

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