Prospective, Multicentre, Randomised Withdrawal Design of a Clinical Trial Evaluating the Safety and Efficacy of a Percutaneous Peripheral Nerve Stimulation System for Patients With Peripheral Neuropathic Pain.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Difference in mean pain visual analogue scale VAS scores between trial and control groups in the randomised withdrawal period
研究概览
简要总结
The goal of this clinical trial is to evaluate safety and efficacy of percutaneous peripheral nerve stimulation in patients with peripheral neuropathic pain. The main questions it aims to answer are:
- The efficacy of percutaneous peripheral nerve stimulation in patients with peripheral neuropathic pain
- The safety of percutaneous peripheral nerve stimulation in patients with peripheral neuropathic pain Participants are going to undergo procedure that implant peripheral nerve stimulation electrode produced by Jiangsu CED Medtech Co., Ltd. Then the subjects, whose VAS scores decrease more 30% than baseline level, are classified into two groups randomly. One of the group receiving active stimulation called trial group and another receiving placebo stimulation called control group. All subjects are required to make their own subjects' pain diary to record VSA score before and after implantation until at the end of follow-up. Also, participants are asked to report use of analgesic medications, number of awakenings and adverse events.
Researchers will compare pain scores between the two groups to see if peripheral nerve stimulation is effective to patients with peripheral neuropathic pain.
详细描述
The investigators divide study process into 3 main periods called enrollment/baseline period, treatment period and follow-up period. The treatment period is classified into test period, randomized withdrawal period and observation period further.
- Enrollment/baseline period This study will be conducted at four clinical trial sites in China with 3 to 6 subjects included in the pretest and the formal trial planned to enroll 56 subjects. All subjects enter screening process after signing the informed consent form (ICF) approved by the ethics committee. Subjects are enrolled who meet inclusion criteria and do not meet any exclusion criteria. Enrolled subjects will undergo vital signs, physical examination, laboratory tests, and visual analogue scale (VAS) scores for pain for at least 4 days, Neuropathic Pain Scale (DN4), and the Short Form Health Survey (SF-36) as part of the screening period assessment prior to electrode implantation.
- Treatment period 2.1 Implantation of devices Enrolled subjects are implanted with the percutaneous peripheral nerve stimulation system, which was parameterized by the investigator via a programmable controller. Subjects are provided with a "Transcutaneous Peripheral Nerve Stimulation Remote Control Instruction Manual" to guide them in the proper operation and use of the system.
2.2 Test period Investigators will adjust stimulation parameters and record VAS score under different parameters conditions. The enrolled subjects are provided 1 to 5 stimulation therapy patterns parameterized by investigators after the test.
Then the subjects receive continuous stimulation with parameterized patterns of 7 (±3) days and VAS scores are be recorded every day of 7 days. Subjects will enter next stage if their VAS scores decrease more than 30% from baseline level or withdraw the trial as reduction less than 30% and devices are removed.
2.3 Randomized withdrawal period Subject will be classified into random group. One of the group receiving active stimulation called trial group and another receiving placebo stimulation called control group. Both of two groups are performed stimulation in the next 7 days. The subjects of control group will get active stimulation again as the VAS scores back to and maintain 2 days at baseline level. VAS scores will be recorded every day during this period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years old and above, male or female
- •Diagnosed by trained clinical doctors as postherpetic neuralgia, which is an indication for peripheral nerve stimulation therapy;
- •Assess the damage or disease of the peripheral sensory system through the four questions of Douleur Neuropathy before surgery;
- •The subject has received conventional treatment but the efficacy is poor, or cannot tolerate the side effects of conventional treatment;
- •Visual analogue scale for pain within 24 hours before surgery ≥ 5;
- •The subjects are able to understand the purpose of this study, have sufficient compliance with the research treatment, and are willing to sign an informed consent form;
排除标准
- •Subjects who need to receive both radio frequency modulation and intrathecal drug infusion treatment simultaneously;
- •Subjects who are known to have cardiac implants (pacemakers or defibrillators) or other implantable neural stimulators (spinal cord stimulators or deep brain stimulators, etc.);
- •Subjects with severe psychological and/or mental disorders and/or non therapeutic drug dependence;
- •Subjects expected to undergo MRI examination within 30 days after PNS implantation;
- •Expected to be discharged within 48 hours or less;
- •Target nerve damage or muscle defects in known pain areas;
- •Subjects who are known to be allergic to skin contact materials (tape or adhesive);
- •Allergy to anesthetics such as lidocaine;
- •Concomitant severe heart disease, liver disease, kidney disease, respiratory system disease, and coagulation dysfunction;
- •Pregnant women, lactating women, or women planning to have children within the next three months;
- •Subjects who have participated in any other clinical trial, or who may participate in any other trial after enrollment;
- •Other situations that the researcher deems unsuitable for participation in this clinical trial
结局指标
主要结局
Difference in mean pain visual analogue scale VAS scores between trial and control groups in the randomised withdrawal period
时间窗: every day from 7 to 14 days after electrode implantation (randomized withdrawal period)
Researchers will collect visual analogue scale scores of 7 days after the implantation of peripheral nerve stimulation electrode to calculate mean scores of 4 days before randomized withdrawal and evaluate the difference in pain improvement of peripheral nerve stimulation between the two groups (trial and control group) by analyzing the mean change in VAS scores during randomized withdrawal period.
Visual simulation assessment scale collects pain scores after peripheral electrode placement
时间窗: Every day from 7 to 28 days after electrode implantation, as well as the 14th day after electrode removal
Researchers collected daily pain scores from the day of peripheral nerve stimulation electrode implantation until removal using the VAS pain scale, as well as pain scores on the 14th day after electrode removal.
次要结局
- Proportion of subjects whose pain relief more than 30%(Every day for 7 days after electrode implantation (test period))
- Analgesic medications(Every day from 4 days before electrode implantation to 14 days after electrode removal.)
- Stability of external assistant devices(Every day from the 1st to 28th day after electrode implantation, as well as the 14th day after electrode removal.)
- Proportion of subjects of ideal pain state(Every day for 7 days after electrode implantation (test period), every day from 7 to 14 days after electrode implantation (randomized withdrawal period), and every day from 14 to 28 days after electrode implantation (observation period))
- Sleep-related assessment after electrostimulation(Every day for 7 days after electrode implantation (test period), every day from 7 to 14 days after electrode implantation (randomized withdrawal period), and every day from 14 to 28 days after electrode implantation (observation period))
- Change of life quality after electrostimulation(4 days before electrode implantation, 7, 14, 21, 28 days after electrode implantation, and 14 days after electrode removal.)
- Questionnaire survey equipment satisfaction(On the first day of electrode implantation and the day of electrode removal (remove the electrode 28 days after surgery).)