Percutaneous Image Guided Cryoablation for the Treatment of Refractory Phantom Limb Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Safety of cryoablation procedure, measured by the number of subjects that had cryoablation procedure events (CPEs).
研究概览
简要总结
The purpose of this study is to determine if treatment with percutaneous cryoablation yields significant differences in the evaluative criteria of Phantom Limb Syndrome (PLS).
详细描述
This study aims to treat Phantom Limb Syndrome (PLS) with cryoablation of the remaining nerve stumps. The rationale is that because the pain in PLS follows the known distribution of nerves, and because the amputated nerves are known to undergo changes after the surgery that may lead to excessive "firing," that interruption of the nerve impulses will reduce patient pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Subjects are status post (s/p) amputation of an upper or lower limb. That is, the amputation is not congenital.
- •Refractory pain symptoms, following tissue healing(postoperatively, or post injury) are related to amputation as determined by referring physician and investigator, to include: stump pain, phantom pain, unpleasant phantom sensations, and/or undesirable and/or life-limiting kinesthetic sensations. The character, frequency, location, description, and exacerbation or relieving elements will be recorded.
- •Patients will be questioned as to the location of their sensation, be it pain, movement, burning, tingling, or other. The location of their pain will be correlated with the corresponding proximal nerve stump.
- •Positive anesthetic/steroid block, as performed under CT guidance in an analogous fashion to the cryoablation procedure.
- •Absence of infection
- •Absence of coagulopathy
- •Ability and willingness of patient to provide written informed consent
排除标准
- •Active infection
- •Underlying congenital segmentation or other spinal anomalies that result in differential nerve root pressures
- •Significant spinal stenosis interpreted as "severe" on any cross sectional imaging study
- •Pregnant or planning to become pregnant
- •Immunosuppression
- •History or laboratory results indicative of any significant cardiac, endocrine, hematologic, hepatic, immunologic, infectious, metabolic, urologic, pulmonary, gastrointestinal, dermatologic, psychiatric, renal, neoplastic, or other disorder that in the opinion of the Principal Investigator would preclude the safe performance of cryoablation.
- •Uncorrectable coagulopathies
- •Concurrent participation in another investigational trial involving systemic administration of agents or within the previous 30 days.
- •Have undergone a previous surgical intervention - post amputation - that may have altered the target nerve.
结局指标
主要结局
Safety of cryoablation procedure, measured by the number of subjects that had cryoablation procedure events (CPEs).
时间窗: 56 days
Safety is measured by the number of subjects that had cryoablation procedure events (CPEs). CPEs are device- or procedure-related serious adverse events (SAE) or adverse events (AE) categorized as clinical signs or symptoms of infection (fever), hemorrhage (pain, imaging changes), nerve pain worsening, or toxicity of any kind (confusion, seizure).
Feasibility of cryoablation, defined by number of participants, in which cryoablation was performed successfully
时间窗: Post-Cryoablation
Feasibility, defined by number of participants, in which cryoablation was performed successfully
次要结局
- Change in pain scores on visual analogue scale (VAS )(Baseline, day 56)
- Change in quality of life, measured using Roland-Morris Disability Questionnaire (RDQ)(Baseline, day 56)
研究者
John Prologo
Assistant Professor
Emory University