Transcutaneous Electrical Nerve Stimulation (TENS) for Phantom Limb Pain Prevention Following Arteriopathic Major Amputation: Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- PREOPERATIVE NEUROPAThIC PAIN EVALUATION
研究概览
简要总结
A growing body of literature indicates that up to 80% of amputees may have phantom limb pain (PLP). The first cause for limb loss is vascular disease. Usually, amputees who suffer from PLP are suboptimal treated. Therefore, many amputees are disabled by their chronic pain. The etiology and pathophysiology of PLP are poorly understood. Some studies suggest a somatosensory cortex reorganization. Transcutaneous Electrical Nerve Stimulation (TENS) is a analgesic technique. TENS apply a low voltage electrical current through the skin using surface electrodes in order to stimulate afferent nerve fibbers. Because of the lack of evidence to support any treatment for PLP, interest has turned to preventing it instead.
The aim of this study is to assess if the early use of TENS in the immediately postoperative of major limb amputation due to peripheral vascular disease, should decrease the PLP incidence. TENS should interfere in the mechanism of PLP production to level of the pain fibers conduction.
详细描述
Introduction:
Postamputation pain is highly prevalent after vascular limb amputation. The physiopathological basis should be divided in supraspinal, spinal and peripheral mechanisms. Supraspinal mechanism involve somatosensory cortical reorganization; spinal reorganization in the dorsal horn, occurs after deafferentation from peripheral nerve injury and peripherical nerve injury begins with the nerve section in surgery. All this factors seems to end into a somatosensory cortex reorganization. In this sense, it seems that our ability to prevent PLP depend on the capability to modulate the plasticity of the Central Nervous System (CNS).
Transcutaneous electrical nerve stimulation it´s a safe, easy and inexpensive analgesic technique acting on the conduction pathways of pain. An adequated program is mandatory: balanced symmetrical biphasic pulse, pulse length greater than 250microsg, modulated high frequency and electrodes placed over the dermatomes corresponding to lumbar-sacral spine; will be used in the intervention patients
Hypothesis:
In patients with TENS use during the immediately postoperative of major limb amputation due to peripheral vascular disease, phantom limb pain will appear with less frequency than in control patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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 over 18 years of both genders
- •Critical limb ischemia (arteriopathic or diabetic aetiology)
- •"MINI MENTAL TEST" (minimum 24 points)
排除标准
- •Pace marker
- •Don´t speak Spanish
- •Not agreement with the study
- •Dermatological lesion affecting the electrode place
结局指标
主要结局
PREOPERATIVE NEUROPAThIC PAIN EVALUATION
时间窗: 3 days before intervention
DN4 Test ( for neuropathic pain). This is the recommended test of the Spanish association on Anesthesiology for determinate neuropathic pain. It consist in several questions to evaluate the clinical situation and some others about the physical situation.
PREOPERATIVE PAIN EVALUATION
时间窗: 3 days before intervention
Analogical Visual Scale: the patient indicate its pain level in the scale witch has an interval between 0-10 DN4 Test ( for neurophatic pain). This is the recommended test of the Spanish association on Anesthesiology for determinate neurophatic pain.
次要结局
- 1 MONTH POSTOPERATIVE HEALTH EVALUATION(1 MONTH)
- 1 MONTH POSTOPERATIVE SLEEP EVALUATION(1 MONTH)
- 3 MONTH POSTOPERATIVE HEALTH EVALUATION(3 MONTH)
- 3 MONTH POSTOPERATIVE SLEEP EVALUATION(3 MONTH)
- INMEDIATELY POSTOPERATIVE PAIN EVALUATION(3 days after intervention)
- 1 MONTH POSTOPERATIVE PAIN EVALUATION(1 MONTH)
- 3 MONTH POSTOPERATIVE PAIN EVALUATION(3 MONTH)
研究者
Barbara Bodega
MD
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana