NCT02337699终止不适用
DORSAL ROOT GANGLION STIMULATION AS TREATMENT FOR POSTSURGICAL GROIN PAIN (GASPA Study)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Feasibility Study: To determine subject acceptance of the described QST methodology and protocol; assessed using a 5 point Likert scale
研究概览
简要总结
25-SMI-2014 is a post market observational, questionnaire based study to assess the effectiveness of the Axium neurostimulator as a treatment for chronic post surgical groin pain. Within is also a nested feasibility study to assess the clinical utility of a Quantitive Sensory Testing (QST) protocol in the management of the described study group.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 18 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age between >18 and <65 years
- •Unilateral post surgical groin pain for >6 months
- •Pain localized to the region defined by the anterior superior iliac spine (ASIS), the pubic tubercle, and the groin-gluteal-greater trochanter triangles (3G) point,
- •Pain has no surgical indication
- •Subjects meet the criteria for SCS implantation as set out in the Dutch Neuromodulation Society Guideline
- •Pain characterized by neuropathy and/or allodynia
- •Average daily baseline pain intensity baseline VAS greater than or equal to 50 mm on a 100mm VAS scale
- •Patient willing and able to give informed consent and to participate in observational study
排除标准
- •Inability to speak/read Dutch
- •Bilateral and/or recurrent hernia.
- •Radiofrequency or injection therapy at or close to a target DRG in the 90 days prior to enrolment
- •Current illicit drug use and/or alcohol dependence
- •Active infection, or conditions or indwelling devices that pose an increased risk of infection
- •Active implantable device including implantable cardiac defibrillator, pacemaker, spinal cord stimulator or intrathecal drug pump
- •Participation in another clinical study during the study period.
- •Any other disorder, condition, or circumstance that, in the opinion of the principal investigator, represents a risk to successful completion of all study activities.
- •Additional Criteria for nested feasibility study
- •Additional Inclusion Criteria
- •Participation in the observational study
- •Sign off for sub-study on patient informed consent
- •Additional Exclusion Criteria
- •For sub-study participation only: pain conditions [aside from the post surgical groin pain to be treated], extensive scar tissue, skin conditions, or sensorimotor abnormalities in the areas for QST assessments: the painful groin, the contralateral groin, the ipsilateral arm, and the contralateral hand
结局指标
主要结局
Feasibility Study: To determine subject acceptance of the described QST methodology and protocol; assessed using a 5 point Likert scale
时间窗: Baseline then Post implantation at; 1, 3 and 6 months
Main Study: Pain Relief - Assessed be Change in Pain Intensity from Pre-Treatment Baseline
时间窗: Post implantation at; 1, 3 and 6 months
次要结局
未报告次要终点
研究者
研究点 (1)
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