Effects of Postoperative Percutaneous Peripheral Nerve Stimulation on Acute and Chronic Amputation Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Average Residual Limb Pain (RLP) Score
研究概览
简要总结
Limb loss is frequently associated with postamputation pain that can be challenging to treat and often involves opioids. Advances in the field of neuromodulation has led to development of an intentionally reversible percutaneous peripheral nerve stimulation (PNS) system that has had promising results when treating chronic postamputation pain. PNS may offer sustained pain relief even after the treatment period has ended. Currently, there is no convincing evidence regarding the role of PNS in the acute postoperative period, which may be a critical time to control pain as those with higher pain appear to be at higher risk for developing persistent post-procedural pain. The investigators of this study aim to evaluate the feasibility and effects of PNS in the acute postoperative period and determine the feasibility of completing a randomized controlled treatment outcome study.
详细描述
16 patients with new nontraumatic transfemoral or transtibial amputation will be enrolled in the study
Having met inclusion criteria, the patients will be randomized to experimental or control groups
Patients in the experimental group undergo placement of PNS leads within 7 days of amputation surgery
Patients in both groups will be treated with standard pharmacologic and nonpharmacologic pain therapies and evaluated weekly for 8 weeks, then at 3, 6, and 12 months postamputation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Nontraumatic transfemoral (above-the-knee) or transtibial (below-the-knee) amputation
- •Presence of postamputation pain rated at least 4 or more
排除标准
- •Beck Depression Inventory score greater than 20
- •Systemic infection
- •Immunocompromised or taking immunosuppressive medications
- •Implanted electronic device
- •Pregnancy
- •Previous allergy to skin contact materials and/or anesthetic agent
- •Altered mental status
- •Inability to provide informed consent
结局指标
主要结局
Average Residual Limb Pain (RLP) Score
时间窗: Baseline, Weeks 1-4, Weeks 5-8, and Month 3
Using the Brief Pain Inventory-Short Form (BPI-SF) questionnaire, subjects were asked to rate their RLP over the past 24 hours on a scale of "0"=no pain to "10"=worst pain they have ever experienced. A lower score is better. Data from Weeks 1-4 and Weeks 5-8 were averaged to obtain a numerical score for these time points.
Worst Phantom Limb Pain (PLP) Score
时间窗: Baseline, Weeks 1-4, 5-8, and Month 3
Using the Brief Pain Inventory-Short Form (BPI-SF) questionnaire, subjects were asked to rate their PLP over the past 24 hours on a scale of "0"=no pain to "10"=worst pain they have ever experienced. A lower score is better. Data from Weeks 1-4 and Weeks 5-8 were averaged to obtain a numerical score for these time points.
Worst Residual Limb Pain (RLP) Score
时间窗: Baseline, Weeks 1-4, Weeks 5-8, and Month 3
Using the Brief Pain Inventory-Short Form (BPI-SF) questionnaire, subjects were asked to rate their RLP over the past 24 hours on a scale of "0"=no pain to "10"=worst pain they have ever experienced. A lower score is better. Data from Weeks 1-4 and Weeks 5-8 were averaged to obtain a numerical score for these time points.
Best Residual Limb Pain (RLP) Score
时间窗: Baseline, Weeks 1-4, Weeks 5-8, and Month 3
Using the Brief Pain Inventory-Short Form (BPI-SF) questionnaire, subjects were asked to rate their RLP over the past 24 hours on a scale of "0"=no pain to "10"=worst pain they have ever experienced. A lower score is better. Data from Weeks 1-4 and Weeks 5-8 were averaged to obtain a numerical score for these time points.
Best Phantom Limb Pain (PLP) Score
时间窗: Baseline, Weeks 1-4, Weeks 5-8, and Month 3
Using the Brief Pain Inventory-Short Form (BPI-SF) questionnaire, subjects were asked to rate their PLP over the past 24 hours on a scale of "0"=no pain to "10"=worst pain they have ever experienced. A lower score is better. Data from Weeks 1-4 and Weeks 5-8 were averaged to obtain a numerical score for these time points.
Average Phantom Limb Pain (PLP) Score
时间窗: Baseline, Weeks 1-4, Weeks 5-8, and Month 3.
Using the Brief Pain Inventory-Short Form (BPI-SF) questionnaire, subjects were asked to rate their PLP over the past 24 hours on a scale of "0"=no pain to "10"=worst pain they have ever experienced. A lower score is better. Data from Weeks 1-4 and Weeks 5-8 were averaged to obtain a numerical score for these time points.
次要结局
- Pain Catastrophizing Scale (PCS)(Baseline, Weeks 4, 8, and 12)
- Number Taking Opioids(Preop, Hospital Discharge, Weeks 1-4, Weeks 5-8, Week 12)
- Functional Independence Measure (FIM) Scores(Preoperative, Week 4, and Week 8)
- Patient Global Impression of Change (PGIC)(Weeks 4, 8, and 12)
- Hospital Length of Stay (LOS)(Number of days from surgery to discharge)
- Average Oral Morphine Equivalents (OME)(Preoperative, Hospital discharge, Weeks 1-4, Weeks 5-8, and Week 12)
- Pain Interference(Baseline, Weeks 4, 8, and 12)
- Pain Disability Index (PDI)(Weeks 4, Week 8, and Week 12)
- 30-day Readmission Rate(30 days from hospital discharge)