Pulsed Electromagnetic Fields for Post-Amputation Pain: A Randomized, Triple-Masked, Sham-Controlled, Crossover Pilot Study
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
- Change in Average RESIDUAL Limb Pain Scores Between Baseline and Day 28 of the Initial Treatment as Measured With the Numeric Rating Scale
研究概览
简要总结
Pulsed electromagnetic field therapy is a possible method of pain control involving the application of electromagnetic energy (also termed nonthermal, pulsed, shortwave radiofrequency therapy). Food and Drug Administration-cleared devices have been in clinical use for over 70 years. For decades, available devices consisted of a large signal generator and bulky coil applicator that were not portable and produced significant electromagnetic interference, making them impractical for common use. However, small, lightweight, relatively inexpensive, noninvasive, Food and Drug Administration-cleared devices that function for 30 days are now available to treat acute and chronic pain, decrease inflammation and edema, and hasten wound healing and bone regeneration. Therefore, it has the potential to concurrently improve analgesia and decrease or even negate opioid requirements, only without the limitations of opioids and peripheral nerve blocks. The purpose of this pilot study is to explore the possibility of treating chronic post-amputation pain with nonthermal, pulsed shortwave (radiofrequency) therapy, optimize the study protocol, and estimate the treatment effect in preparation for developing subsequent definitive clinical trials.
详细描述
The proposed study will be a randomized, participant- and observer-masked, sham-controlled, crossover, human participants pilot study with two primary aims:
Specific Aim 1: To determine the feasibility and optimize the protocol for subsequent clinical trials that will compare the addition of nonthermal, pulsed shortwave therapy to usual and customary analgesia for post-amputation phantom and residual limb pain.
Specific Aim 2: To estimate the treatment effect of adding nonthermal, pulsed shortwave therapy to usual and customary analgesia for post-amputation phantom and residual limb pain. This will provide an idea of the optimal amputee characteristics amenable to this analgesic technique and allow determination of the required sample sizes of subsequent definitive clinical trials.
Hypothesis: Nonthermal, pulsed shortwave therapy will decrease pain in the 28 days following application for post-amputation pain.
This will be a single-center (University of California San Diego), randomized, participant- and observer-masked, sham-controlled, crossover human subjects pilot study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The Investigational Drug Service will create the randomization tables and provide the investigators with the appropriate device (active or sham), leaving all participants, investigators, and the statistician masked to treatment group assignment.
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
- •adult patients of at least 18 years of age [19 years in Alabama and Nebraska]
- •with an upper or lower limb amputation at least 12 weeks prior to enrollment distal to the shoulder or hip (femoral head remaining), respectively, and including at least one metacarpal or metatarsal bone, respectively
- •experience at least moderate residual and/or phantom limb pain-defined as a 3 or higher on the Numeric Rating Scale (NRS; 0-10, 0= no pain; 10=worst imaginable pain)-at least daily for the previous 2 months
- •willing to avoid both changes to their analgesic regimen as well as elective surgical procedures for 70 days after initiation of treatment with PEMF therapy
排除标准
- •concurrent use of an implanted pulse generator (e.g., cardiac pacemaker)
- •pregnancy
- •incarceration
结局指标
主要结局
Change in Average RESIDUAL Limb Pain Scores Between Baseline and Day 28 of the Initial Treatment as Measured With the Numeric Rating Scale
时间窗: Baseline and Day 28
The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale. The outcome will be the difference between the baseline and Day 28 timepoints.
Change in Average PHANTOM Limb Pain Scores Between Baseline and Day 28 of the Initial Treatment as Measured With the Numeric Rating Scale
时间窗: Baseline and Day 28
The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale. The outcome will be the difference between the baseline and Day 28 timepoints.
Patient Global Impression of Change for RESIDUAL Limb Pain Between Baseline and Day 28 of the Initial Treatment
时间窗: Day 28
A 7-point Likert scale with 1 equivalent to "much worse", 4 equivalent to "no change", and 7 equivalent to "much improved". Patients compare their current pain level with baseline using this scale.
Patient Global Impression of Change for PHANTOM Limb Pain Between Baseline and Day 28 of the Initial Treatment
时间窗: Day 28
A 7-point Likert scale with 1 equivalent to "much worse", 4 equivalent to "no change", and 7 equivalent to "much improved". Patients compare their current pain level with baseline using this scale.
次要结局
- Patient Global Impression of Change for RESIDUAL Limb Pain(Days 2, 4, 7, 21, 28, and 35)
- Patient Global Impression of Change for PHANTOM Limb Pain(Days 2, 4, 7, 21, 28, and 35)
- Change in AVERAGE RESIDUAL Pain From Baseline Measured With the Numeric Rating Scale(Days 2, 4, 7, 21, 28, and 35)
- Change in WORST RESIDUAL Pain From Baseline Measured With the Numeric Rating Scale(Days 2, 4, 7, 21, 28, and 35)
- Change in LEAST RESIDUAL Pain From Baseline Measured With the Numeric Rating Scale(Days 28 and 35)
- Change in CURRENT RESIDUAL Pain From Baseline Measured With the Numeric Rating Scale(Days 28 and 35)
- Change in AVERAGE PHANTOM Pain From Baseline Measured With the Numeric Rating Scale(Days 2, 4, 7, 21, 28, and 35)
- Change in WORST PHANTOM Pain From Baseline Measured With the Numeric Rating Scale(Days 2, 4, 7, 21, 28, and 35)
- Change in LEAST PHANTOM Pain From Baseline Measured With the Numeric Rating Scale(Days 28 and 35)
- Change in CURRENT PHANTOM Pain From Baseline Measured With the Numeric Rating Scale(Days 28 and 35)
- As-needed (Non-scheduled) Analgesic Use(Inquired on Day 2, 4, 7, 21, 28 and 35 for both initial and crossover treatments)
- Brief Pain Inventory, Short Form (Interference Sub Scale)(Inquired on Days 28 and 35)
- Awakenings Due to Pain the Previous Evening(Inquired on Days 2, 4, 7, 21, 28, and 35)
- Does Patient Want to Continue Using Device (Participants Answering "Yes")?(Inquired on Day 35)
- Device Location Changes(Inquired on Days 2, 4, 7, 21, 28 and 35)
研究者
Brian M. Ilfeld, MD, MS
Professor of Anesthesiology, In Residence
University of California, San Diego