Passive Recharge Burst Spinal Cord Stimulation vs Sham Stimulation in Established Responders: A Randomized, Double-Blind Crossover Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Within-Participant Difference in Period-Level Median Numeric Rating Scale Pain Intensity Between Active BurstDR and Sham
研究概览
简要总结
This study aims to determine whether ongoing BurstDR spinal cord stimulation (SCS) provides pain relief beyond sham stimulation in patients with chronic pain who are established responders to BurstDR therapy.
Participants already implanted with an SCS system and experiencing stable clinical benefit from BurstDR will undergo both active stimulation and sham stimulation in a randomized, double-blind crossover design. Each participant will therefore serve as their own control.
The primary question is whether pain intensity is lower during active BurstDR stimulation compared with sham stimulation. The study will also evaluate treatment satisfaction, patient-reported changes in sleep, mood, daily activity and social activity, the effectiveness of blinding, and short-term safety and tolerability.
详细描述
BurstDR spinal cord stimulation is a paresthesia-free neuromodulation therapy used for the treatment of chronic pain. Although clinical studies have demonstrated beneficial outcomes with BurstDR therapy, the specific contribution of ongoing stimulation, separate from contextual effects, expectation, natural symptom variation, and other nonspecific influences, remains incompletely defined.
This study uses a randomized, double-blind, two-period crossover design in patients who are already implanted with a spinal cord stimulation system and have an established clinical response to BurstDR therapy. Studying established responders avoids potential confounding associated with implantation, postoperative recovery, and initial programming and optimization, and allows the effect of ongoing stimulation to be evaluated under controlled conditions.
Before the randomized treatment periods, each participant will complete a baseline observation under their established active BurstDR settings, followed by a washout period with stimulation switched off. Participants will then undergo two randomized treatment periods: one with active BurstDR stimulation and one with sham stimulation, separated by a second washout period. The order of the two conditions will be randomly assigned, allowing each participant to serve as their own control and thereby reducing the influence of between-patient variability.
During the active condition, stimulation will be delivered using the participant's established clinically effective BurstDR program. During the sham condition, stimulation output will be switched off while study procedures, participant contacts, and data collection will otherwise remain comparable between conditions.
Because BurstDR stimulation is intended to be paresthesia-free, it provides an opportunity for blinded comparison with sham stimulation. Before the randomized treatment phase, a standardized perceptibility assessment will be performed to confirm that participants cannot reliably perceive whether stimulation is active. Device access and information that could reveal treatment allocation will be restricted, and treatment programming will be performed by designated study personnel who are not involved in outcome assessment or the primary analysis.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Data analysts will also remain masked to treatment allocation. Only the designated programmer or study nurse responsible for randomization-linked device programming will have access to the treatment allocation. This individual will have no role in outcome assessment or the primary analysis.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must meet all of the following:
- •Be 18 years of age or older.
- •Have an implanted spinal cord stimulation system that can deliver BurstDR stimulation.
- •Have had a good and stable response to BurstDR therapy, defined as at least a 50% reduction in pain compared with pain before implantation or before starting BurstDR therapy, maintained for at least 3 months on stable stimulation settings.
- •Have had no major change in pain medication for at least 4 weeks before entering the study.
- •Be able to understand the study information and provide written informed consent.
- •Be willing and able to complete the study's electronic diaries and follow the study procedures.
排除标准
- •Participants cannot take part if any of the following apply:
- •An active infection, wound problem, or other significant problem at the site of the implanted spinal cord stimulation system.
- •A known or suspected problem with the implanted stimulation system that could affect treatment delivery or safety.
- •A serious uncontrolled mental health condition, significant problems with memory or thinking, or another condition that could make it difficult to understand the study, provide informed consent, follow the study procedures, or provide reliable study information.
- •Planned surgery, planned changes to spinal cord stimulation programming outside the study, or an expected change in pain medication during the study period.
- •Pregnancy or breastfeeding.
- •Inability to use the electronic diary system when no practical alternative or assistance can be provided.
- •Any other medical or personal condition that, in the investigator's judgment, would make participation unsafe or inappropriate.
研究组 & 干预措施
equence 1: Active BurstDR → Sham
Following a 1-day baseline observation under established active BurstDR settings, participants undergo a 4-day washout period with stimulation switched off. They then receive 7 days of active BurstDR spinal cord stimulation using their established clinically effective settings. After a second 4-day washout period with stimulation switched off, participants receive 7 days of sham stimulation, during which stimulation output remains switched off.
干预措施: BurstDR Spinal Cord Stimulation (Device)
equence 1: Active BurstDR → Sham
Following a 1-day baseline observation under established active BurstDR settings, participants undergo a 4-day washout period with stimulation switched off. They then receive 7 days of active BurstDR spinal cord stimulation using their established clinically effective settings. After a second 4-day washout period with stimulation switched off, participants receive 7 days of sham stimulation, during which stimulation output remains switched off.
干预措施: Sham Spinal Cord Stimulation (Device)
Sequence 2: Sham → Active BurstDR
Following a 1-day baseline observation under established active BurstDR settings, participants undergo a 4-day washout period with stimulation switched off. They then receive 7 days of sham stimulation, during which stimulation output remains switched off. After a second 4-day washout period with stimulation switched off, participants receive 7 days of active BurstDR spinal cord stimulation using their established clinically effective settings.
干预措施: BurstDR Spinal Cord Stimulation (Device)
Sequence 2: Sham → Active BurstDR
Following a 1-day baseline observation under established active BurstDR settings, participants undergo a 4-day washout period with stimulation switched off. They then receive 7 days of sham stimulation, during which stimulation output remains switched off. After a second 4-day washout period with stimulation switched off, participants receive 7 days of active BurstDR spinal cord stimulation using their established clinically effective settings.
干预措施: Sham Spinal Cord Stimulation (Device)
结局指标
主要结局
Within-Participant Difference in Period-Level Median Numeric Rating Scale Pain Intensity Between Active BurstDR and Sham
时间窗: During each 7-day randomized treatment period (Days 5-11 and Days 16-22 after baseline)
Pain intensity is recorded twice daily, morning and evening, using an 11-point Numeric Rating Scale (NRS; 0=no pain to 10=worst pain) for each predefined pain area during each randomized treatment period. All available NRS ratings within each participant and treatment period are pooled, and the period-level median is calculated. The primary outcome is the within-participant paired difference between sham and active BurstDR stimulation (Sham minus Active), with positive values favoring active BurstDR. Baseline-day NRS data are not included in the primary endpoint.
次要结局
- Within-Participant Difference in End-of-Period Treatment Satisfaction Score Between Active BurstDR and Sham(At the end of each 7-day randomized treatment period (Day 11 and Day 22 after baseline))
- Within-Participant Difference in Period-Level Median Patient Global Impression of Change Score for Sleep Quality(Daily during each 7-day randomized treatment period (Days 5-11 and Days 16-22 after baseline))
- Within-Participant Difference in Period-Level Median Patient Global Impression of Change Score for Mood(Daily during each 7-day randomized treatment period (Days 5-11 and Days 16-22 after baseline))
- Within-Participant Difference in Period-Level Median Patient Global Impression of Change Score for Daily Activity(Daily during each 7-day randomized treatment period (Days 5-11 and Days 16-22 after baseline))
- Within-Participant Difference in Period-Level Median Patient Global Impression of Change Score for Social Activity(Daily during each 7-day randomized treatment period (Days 5-11 and Days 16-22 after baseline))
- Perceptibility of Active BurstDR Stimulation Before Randomized Treatment(At the baseline/programming visit, before the 1-day baseline diary and before Washout 1)
- Number of Participants With Adverse Events, Serious Adverse Events, and Stimulation-Related Complaints(From baseline through Day 22 after baseline (completion of the second randomized treatment period))
- Participant-Reported Perception of Stimulation During Each Randomized Treatment Period(At the end of each 7-day randomized treatment period (Day 11 and Day 22 after baseline))
研究者
Pedram Tabatabaei Shafiei
MD, PhD
Umeå University