NCT03110601已完成不适用
Trialing of PM Modulation Therapy in Patients With Chronic Intractable Low Back Pain With or Without Leg Pain
Stimgenics LLC2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2017年5月5日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Change in Pain Relative to Baseline and After a Trial Period
研究概览
简要总结
Trialing of PM modulation therapy in patients with chronic intractable low back pain
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Capable of giving written informed consent to participate in this clinical study based on voluntary agreement after a thorough explanation of the patient's participation is provided to them.
- •Chronic intractable pain of the lower back equal to or greater than pain in lower limbs, and that has been refractory to conservative therapy for ≥ 3 months.
- •Must be older than 18 years old.
- •Average back pain intensity of ≥ 5 out of 10 on the numerical pain rating scale (NPRS).
- •Appropriate candidate for spinal cord stimulation trial.
- •Subjects must be on a stable dose of pain medication regimen for at least 1 month.
- •Female patients who are not pregnant and do not plan to become pregnant during the study. Females of child bearing potential must provide a negative pregnancy test and must be using reliable contraception and must continue to use reliable contraception until study completion. Non-childbearing potential is defined as postmenopausal for at least 2 years or surgical sterilization or hysterectomy at least 3 months before study start. Patients who become pregnant or who have a spouse/significant other that becomes pregnant during the course of this study agree to report pregnancy to the study physician/staff.
- •Must be able to comply with the requirement of study visits and follow-up and phone visits.
- •Have cognitive ability of operate the remote control and follow therapy instructions and directions by clinicians.
排除标准
- •Systemic infection.
- •Any active implanted device.
- •Previous experience with SCS therapy either during a trial or fully implanted
- •Evidence of serious neurological, psychological or psychiatric disorders.
- •Mechanical spinal instability.
- •Patients with uncorrected coagulation disorders or who are on anticoagulation therapy and cannot interrupt the therapy.
- •Patient who are pregnant, breast-feeding or women of childbearing potential with positive pregnancy tests.
- •Human immunodeficiency virus (HIV) infection or a clinically significant infection.
- •Patients who are undergoing or will undergo therapies or diagnostics that involve electromagnetic fields such as: diathermy based therapies, electrocautery, magnetic resonance imaging (MRI), radiofrequency (RF) or microwave ablation, bone growth stimulators, electrolysis, therapeutic ultrasound, ultrasound, lithotripsy, psychotherapeutic procedures, radiation therapy, and transcutaneous electrical nerve stimulation.
- •A clinically significant disorder such as cerebrovascular disease, pulmonary infarction, ischemic heart disease, cardiac dysrhythmia, myocardial infarction, or congestive heart failure or any other as determined by the investigator.
- •Uncontrolled diabetes, uncontrolled pulmonary disease, or uncontrolled hypertension.
- •Patients who have evidence of major psychiatric disease, mental disorder, drug dependency, alcohol dependency, or substance abuse disorders.
- •Patients who have progressive neurological disease such as multiple sclerosis, chronic inflammatory demyelinating polyneuropathy, rapidly progressive arachnoiditis, acute herniated disc, or any other as determined by investigator.
- •Medical condition or pain in other body areas that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study end points.
- •Concurrent participation in another clinical study.
- •Involvement in an injury claim under current litigation or a pending or approved workers' compensation claim.
研究组 & 干预措施
Control - Conventional SCS
Active Comparator
Conventional SCS parameters for 4 days plus/minus 1 day using an external SCS modulator.
干预措施: Control - Conventional SCS (Device)
Washout Period
No Intervention
1 day where no stimulation is provided
Test - Stimgenics SCS
Experimental
Stimgenics SCS parameters for 4 days plus/minus 1 day using an external SCS modulator.
干预措施: Test - Stimgenics SCS (Device)
结局指标
主要结局
Change in Pain Relative to Baseline and After a Trial Period
时间窗: Baseline and 4 days plus or minus 1 days
Numerical rating pain score measured before and after intervention. 11-point Numeric Pain Rating Scale (NPRS) with 0 being no pain at all and 10 being the worst pain imaginable (1-3 is rated as mild pain, 4-6 is rated at moderate pain, 7-9 is rated as severe pain). Subject rates average pain for the past 7 days.
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
已完成
4 期
Pilot Study of the Efficacy and Safety of Lidoderm Patch in the Treatment of Low Back PainChronic Low Back PainNCT00904475Endo Pharmaceuticals102
已完成
不适用
A Trial Comparing Mechanical Diagnosis and Treatment to Manual TherapyChronic Lower Back PainNCT03049644Canandaigua VA Medical Center15
Unknown
3 期
Treatment of Chronic Low Back Pain: A Trial Comparing Traditional Back School and Individual Therapist-Assisted ExerciseChronic Low Back PainNCT00256373University Hospital, Gentofte, Copenhagen
Unknown
不适用
Photobiomodulation Therapy (PBMT) in Patients With Low Back Pain (LBP)Low Back PainNCT04476095University of Nove de Julho72
已完成
2 期
PF-06372865 In Subjects With Chronic Low Back PainChronic Low Back PainNCT02262754Pfizer302