Cooled Radiofrequency Ablation for the Treatment of Refractory Phantom and Residual Limb Pain; a Pilot Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Numeric Rating Scale (NRS) for Pain at 6 Months
研究概览
简要总结
To assess changes in pain, physical function, and health-related quality of life in patients with post-amputation neuroma-associated residual limb pain after cooled radiofrequency ablation.
详细描述
Residual limb (RLP) and phantom limb pain (PLP) affects most amputees at some point in their life1. The incidence of PLP has been estimated to range between 50 - 80%. RLP prevalence has been estimated to be 43%. The peak of onset is bimodal and often appears within the first month and second year after amputation. RLP is more common in the first year after amputation, with PLP becoming the predominate amputee pain complaint after one-year post-amputation.
Both RLP and PLP fall under the umbrella term "post-amputation pain." While these conditions are frequently found in combination, their clinical features and underlying causes are distinct. PLP is a painful sensation in the distribution of the missing limb. Following amputation, abnormalities at multiple levels of the neural axis have been implicated in the development of PLP; changes include cortical reorganization, reduced inhibitory processes at the spinal cord, synaptic response changes and hyperexcitability at the dorsal root ganglion, and retrograde peripheral nerves shrinkage.
Residual limb pain has been called "neuroma pain" and is mechanistically distinct from PLP11. Neuromas may form as early 6-10 weeks after nerve transection, and are thought the produce ectopic neural discharges resulting in severe pain. Evidence suggests RLP and PLP commonly co-occur and patients may struggle to differentiate between these pain types. Risk factors include female sex, upper extremity amputation, pre-amputation pain, residual pain in contralateral limb, and time since amputation.
Depression, anxiety, and stress are known to exacerbate PLP / RLP. Patients experiencing PLP and RLP also experience a higher incidence of indecisiveness, suicidal ideation, and thoughts of self-harm8. Current guidelines for treatment of PLP and RLP are not standardized. Treatments includes pre-operative analgesia, neuromodulation mirror therapy, imagery, acupuncture, transcranial stimulation, deep brain stimulation, and medications (including, but not limited to: TCAs, SSRIs, gabapentinoids, sodium channel blockers, ketamine, opioids, and NSAIDs). Many agents have been injected in neuromas. These include local anesthetic, phenol, alcohol, and botulinum toxin. These oral, intravenous, and nonpharmacological modalities have demonstrated limited success in the treatment of PLP / RLP. Neuroma cryoablation has been used, but this method of neural destruction poses technical challenges related to cumbersome needle placement and the requirement for time-intensive freeze-thaw cycles.
Conventional RFA has been studied on RLP. Zhang et. al treated 13 patients with painful stump neuromas. The study started with alcohol neurolysis before using ultrasound-guided RFA for refractory cases. The frequency of sharp pain was reduced in all RFA-treated patients. Kim et. al described a case in which ultrasound-guided RFA was successfully used to treat a sciatic neuroma of an above-knee amputee.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Age greater than 18 years of age at day of enrollment.
- •Clinical diagnosis lower extremity amputation performed more than 1 year since study enrollment.
- •Residual pain described as burning pain and sensations of movement in the affected amputated limb
- •Pain duration of more than 6 months despite a trial of conservative therapy (medications, physical therapy) for 2 months.
- •Ultrasound and / or MRI imaging pathology consistent with clinical symptoms and signs.
- •Greater than 50% pain relief with a diagnostic neuroma block
排除标准
- •Refusal or inability to participate, provide consent, or provide follow-up information for the 12-month duration of the study.
- •Contraindications to diagnostic block or treatment ablation (active infection, bleeding disorders, and pregnancy or breastfeeding, active immunosuppression, participation in another phantom or residual limb pain trial within the last 30 days
- •Non-neurogenic source of residual or phantom limb pain.
- •Active moderate to severe lumbar radiculopathy.
- •Any injection in the residual limb within the last 30 days.
- •Severe uncontrolled medical condition as determined by treating physician.
- •Severe psychological illness.
- •History of Inflammatory arthritis.
- •Malignancy within past 5 years except basal cell or squamous cell skin cancer.
- •Current opioid use exceeding50morphinemilligram equivalents per day.
- •A history of alcohol or drug abuse within past 5 years.
- •Use of any investigational drug within past 30 days.
- •Pending litigation involving participant's residual limb pain.
- •Incarceration
研究组 & 干预措施
Residual Limb Pain in affected amputated limb
Patient has residual limb pain in amputated limb and is scheduled to receive standard of care treatment of cooled radiofrequency ablation.
干预措施: Cooled Radiofrequency Ablation (Device)
结局指标
主要结局
Numeric Rating Scale (NRS) for Pain at 6 Months
时间窗: 6 months
Presented here is the proportion of participants reporting ≥50% improvement in Numeric Rating Scale pain score at 6 months after their cooled radiofrequency ablation procedure. The Numeric Rating Scale was used to quantify neuroma-associated residual limb pain by asking patients to rate their pain intensity on an 11-point scale ranging from 0 to 10, with 0 representing "no pain at all" and 10 representing "the worst pain imaginable".
次要结局
- Median Change in Numeric Rating Scale (NRS) Scores for Pain(1, 3, 6, and 12 months)
- Medication Quantification Scale III Mean Score(1, 3, 6 and 12 Months)
- Proportion of Patients With a ≥6 Score on Patient Global Impression of Change (PGIC)(1, 3, 6, and 12 months)
研究者
Zack McCormick
Zachary McCormick, MD FAAPMR, Associate Professor, Director of Clinical Spine Research, Director of Interventional Spine and Musculoskeletal Medicine Fellowship
University of Utah