Single Blinded, Randomized Control Trial of High Frequency Stimulation in Subjects With Precision® Spinal Cord Stimulator System to Assess Efficacy and Preferability in Back and Extremity Pain Relief
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Numeric Pain Rating Scale (NPRS)
研究概览
简要总结
Study designed to compare the conventional stimulation programming versus the high frequency stimulation programming of the spinal cord stimulator for subjects who already have a spinal cord stimulator.
详细描述
Subject with Precision models of spinal cord stimulators will be invited to take part in the study that will compare the high frequency stimulation versus low frequency stimulation to look for any changes in efficacy, and preferability between high and low frequency stimulation program for the spinal cord stimulator (SCS) system.
The study is designed as 7 week study that can take up to 9 weeks per subject. 7 weeks are divided into 3 segments. First segment will be 3 weeks of spinal cord stimulation followed by second segment of wash off period, which will take 1 week (7 days), then the last segment with 3 weeks of spinal cord stimulation. At the end of each segments, there will be a follow up visits.
Each follow up visits can occur up to 5 business days after the follow up due date for post spinal cord stimulation follow ups, and up to 3 business days after the follow up due date for the post wash off visit.
At each visits, including baseline, subject will be asked to answer Numeric Pain Rating Scale (NPRS), Oswestry Disability Index (ODI), and Patients Global Impression of Change (PGIC) to assess interval effect of the programming parameter for the spinal cord stimulator.
Visit schedule and assessment summary:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject must be 18 years and older, and younger than 70 years of age.
- •Subject has had a Precision® spinal cord stimulator system implanted for chronic painful condition.
- •Subject pain scores >5 on NPRS
排除标准
- •Currently diagnosed with cognitive impairment, or exhibits any characteristic, that would limit study candidate's ability to assess pain
- •Unstable medical or psychiatric illness
- •Lifetime history of psychosis, hypomania, or mania.
- •Epilepsy, or dementia
- •Substance abuse in the last 6 months
- •Pregnant or breastfeeding
- •Not on contraception for those of childbearing age. (Barrier methods, oral contraception, hormone injections, or surgical sterilization)
- •Treatment with investigational drug within 30 days of screening.
- •Concomitant medication exclusions consisting of medications or herbal agents with central nervous system (CNS) effects with exception of episodic use of sedating antihistamines
研究组 & 干预措施
Treatment group A
Subjects assigned to treatment group A will begin the 7 week study with high frequency stimulation for first 3 weeks of the study. After first 3 weeks, subject will return to clinic to turn off the SCS device, and will start 7-10 days of wash off period. At the end of the wash off period, subject will return to clinic and have the SCS device turned on to have it programmed to deliver the low frequency stimulation for the next 3 weeks. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study.
干预措施: High frequency stimulation (Other)
Treatment group A
Subjects assigned to treatment group A will begin the 7 week study with high frequency stimulation for first 3 weeks of the study. After first 3 weeks, subject will return to clinic to turn off the SCS device, and will start 7-10 days of wash off period. At the end of the wash off period, subject will return to clinic and have the SCS device turned on to have it programmed to deliver the low frequency stimulation for the next 3 weeks. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study.
干预措施: Low frequency stimulation (Other)
Treatment group B
Subjects assigned to treatment group B will begin the 7 week study with low frequency stimulation for first 3 weeks of the study. After first 3 weeks, subject will return to clinic to turn off the SCS device, and will start 7-10 days of wash off period. At the end of the wash off period, subject will return to clinic and have the SCS device turned on to have it programmed to deliver the high frequency stimulation for the next 3 weeks. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study.
干预措施: High frequency stimulation (Other)
Treatment group B
Subjects assigned to treatment group B will begin the 7 week study with low frequency stimulation for first 3 weeks of the study. After first 3 weeks, subject will return to clinic to turn off the SCS device, and will start 7-10 days of wash off period. At the end of the wash off period, subject will return to clinic and have the SCS device turned on to have it programmed to deliver the high frequency stimulation for the next 3 weeks. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study.
干预措施: Low frequency stimulation (Other)
结局指标
主要结局
Numeric Pain Rating Scale (NPRS)
时间窗: Baseline (visit 1), and at each follow up visits (visits 2, 3, and 4)
Digital pain rating system that scores patient's subjective pain rating from 0 to 10; with greater number indicating progressively worsening pain. NPRS were measured at baseline (visit1), and at each follow ups visits at visit 2, 3 and 4. Visit 2 and 4 captured post treatment (either 1000 Hz or standard stimulation depending on the randomization) results, and visit 3 captured NPRS after the wash off from the spinal cord stimulation.
次要结局
- Oswestry Disability Index Questionnaire (ODI).(Baseline (visit 1), and at each follow up visits (visits 2, 3, and 4))
- Patient's Global Impression of Change (PGIC)(Baseline (visit 1), and at each follow up visits (visits 2, 3, and 4))