NCT02549183已完成不适用
Evaluation of Stimulation Pulse Rate on Clinical Outcomes in Patients Whose Pain is Controlled by 10KHz Frequency - a Feasibility Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 6
- 主要终点
- Back pain relief
研究概览
简要总结
Clinical study to estimate the optimal frequency for stimulation of the spinal cord to achieve relief from back pain.
详细描述
This is a feasibility study to identify the optimal frequency for stimulation of the spinal cord to achieve maximum reduction in neuropathic back pain as measured by average Numerical rating Scale.
Twenty patients who suffer from back more than leg pain will be recruited into the study once they have satisfactory pain relief from both low and high frequency stimulations. Each patient will then receive stimulation at four different frequencies for 2-3 weeks in a random and blinded order. Their pain scores and function will be assessed using a variety of different tools. The data will then be used to estimate the optimal frequency.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Complaint of persistent or recurrent low back pain, with or without equal or lesser leg pain, for at least 90 days prior to Screen.
- •Received at least 90 days of documented pain management care to address the primary pain complaint, prior to Screening (e.g. medication, physical therapy.)
- •No back surgery within 6 months prior to Screening.
- •Average low back pain intensity, during the position/activity, which routinely causes worst pain, of 5 or greater on a 0-10 numerical rating scale during Baseline period based on eDiary.
- •If taking prescription opioids for primary chronic pain complaint (low back and/or leg pain), must have been on a stable prescription (same drug(s) and dose(s)) 30 days prior to Screening to a total of less than 180 mg Oral Morphine equivalent
- •Willing and able to comply with all protocol-required procedures and assessments/evaluations (e.g. willing to comply with opioid prescription lock from the Baseline visit through End of Rate Randomization and protocol required stimulation parameter locks, complete daily eDiary).
- •18 years of age or older when written informed consent is obtained.
- •If female of childbearing potential: not pregnant, as evidenced by a negative pregnancy test at Screening.
- •Subject signed a valid, IRB-approved informed consent form (ICF) provided in English.
- •Baseline Oswestry Disability Index score ≥ 20 and ≤
- •Received at least 30 per cent reduction in NRS of average low back pain intensity from Baseline during the end of Post Implant HF10 Sweet-Spot Search as recorded in the eDiary.
排除标准
- •Average worst leg pain intensity is greater than average worst low back pain intensity as reported during Baseline period based on eDiary.
- •Radiographic evidence of spinal instability requiring fusion.
- •Primary pain complaint of vascular origin (e.g. peripheral vascular disease).
- •Spinal pain secondary to neoplasm, infection, autoimmune disorder with spinal involvement, or a spinal metabolic disorder.
- •Any pain-related diagnosis or medical/psychological condition that, in the clinician's best judgment might confound reporting of study outcomes (e.g. pelvic pain, angina pain, chronic migraine.
- •Participating (or intends to participate) in another clinical study.
- •Terminal illness with anticipated survival 1 year.
- •Current condition associated with risk of immunocompromised that might increase risk of infection during study duration.
- •Currently on any anticoagulant medications that cannot be discontinued during perioperative period.
- •Are pregnant/lactating or not using adequate birth control.
- •Have untreated major psychiatric comorbidity, serious drug related behaviour issues.
结局指标
主要结局
Back pain relief
时间窗: Three months
Mean reported pain on Numerical Rating Scale (NRS)
次要结局
- Change in quality of life (EQ-5D) from Baseline Visit to end of Long-Term Follow-up(6-9 months)
- Leg pain relief(3-6 months)
- Patient global impression of change at end of Long-Term Follow-up(6-9 months)
- Change in activities of Daily Living related to back pain disability from Baseline visit to end of Long-Term Follow-up(6-9 months)
研究者
研究点 (6)
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