Evidence map›Paper›PMID 33028415›Full record

ArticleTrials2020

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 and 9 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03858790 (Spinal Cord Stimulation System in the Treatment of Chronic Pain), which is not on this map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
1.3field-weighted citation impact, top 20% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03858790 naunknown statusnot on this map

Spinal Cord Stimulation System in the Treatment of Chronic Pain

TypeinterventionalSponsorBeijing Pins Medical Co., LtdRan2019 to 2020Enrolled54ConditionsPain, Chronic Pain, Back Pain, Spinal Cord StimulationArmsPINS Spinal Cord Stimulator
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 6 citations in OpenAlex.

  1. Implanted spinal neuromodulation interventions for chronic pain in adults.The Cochrane database of systematic reviews · 2021
    Pooled it
  2. Article
  3. Article
  4. Article
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors at 16 institutions in 1 country.

Yang LuDepartment of Neurosurgery, Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University, Beijing, China.
Peng MaoDepartment of Pain Medicine, China-Japan Friendship Hospital, Beijing, China.
Guihuai WangDepartment of Neurosurgery, Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University, Beijing, China.
Wei TaoDepartment of Neurosurgery, Shenzhen University General Hospital, Shenzhen, China.
Donglin XiongDepartment of Pain Medicine, Huazhong University of Science and Technology of Union Shenzhen Hospital, Shenzhen, China.
Ke MaDepartment of Algology, Xinhua Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.
Rongchun LiDepartment of Pain Management, Wuhan Pu'ai Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Dan FengDepartment of Pain Management, Wuhan No. 1 Hospital, Wuhan, China.
Wanru DuanDepartment of Neurosurgery, Xuanwu Hospital, Capital Medical University, Beijing, China.
Shun LiDepartment of Pain, Zhejiang Provincial People's Hospital, People's Hospital of Hangzhou Medical College, Hangzhou, China.
Zhijian FuDepartment of Pain Management, Shandong Provincial Hospital Affiliated to Shandong University, Jinan, China.
Zhiying FengDepartment of Pain Medicine, The First Affiliated Hospital of Medical School of Zhejiang University, Hangzhou, China.
Yi JinDepartment of Anesthesiology, Nanjing Jinling Hospital, Nanjing, China.
Li WanDepartment of Pain Management, The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.
Yan LuDepartment of Pain Medicine, Xijing Hospital, Fourth Military Medical University, Xi'an, China.
Daying ZhangDepartment of Pain Medicine, The First Affiliated Hospital of Nanchang University, Nanchang, China.
Bifa FanDepartment of Pain Medicine, China-Japan Friendship Hospital, Beijing, China. fbf1616@yeah.net.
James Jin WangDepartment of Neurosurgery, Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University, Beijing, China. wja01068@btch.edu.cn.
Luming LiNational Engineering Laboratory for Neuromodulation, School of Aerospace Engineering, Tsinghua University, Beijing, China. lilm@mail.tsinghua.edu.cn.
Beijing Tsinghua Chang Gung Hospital · CNChina-Japan Friendship Hospital · CNTsinghua University · CNAir Force Medical University · CNCapital Medical University · CNFirst Affiliated Hospital of Nanchang University · CNFirst Affiliated Hospital Zhejiang University · CNHuazhong University of Science and Technology · CNJinling Institute of Technology · CNSecond Affiliated Hospital of Guangzhou Medical University · CNShandong University · CNShenzhen University · CNUnion Hospital · CNWuhan No.1 Hospital · CNXinHua Hospital · CNZhejiang Provincial People's Hospital · CN

Funding

Beijing New-star Plan of Science and Technology Program Z181100006218129National Natural Science Foundation of China 81527901The National Key Research and Development Program of China 2016YFC0105502
6 · The paper itself

Abstract

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 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 registrationClinicalTrials.gov NCT03858790 . Registered on March 1, 2019, retrospectively registered.

Indexed as

Chronic PainSpinal Cord StimulationChinaHumansMulticenter Studies as TopicPain MeasurementProspective StudiesQuality of LifeRandomized Controlled Trials as TopicSpinal CordTreatment OutcomeChronic intractable painEfficacyRandomized controlled trialSafetySpinal cord stimulation

Identifiers

PMID33028415
PMCPMC7542759
OpenAlexW3092578480

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.