Efficacy of Percutaneous Electrical Nerve Stimulation Compared With Passive Assisted Neurodynamics in Brachial Plexus Neuropathy: a Pilot Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Pain Detect Scale
研究概览
简要总结
Brachial plexus neuropathies, specifically of the median, radial, ulnar, suprascapular, axillary and dorsal scapular nerves, can arise when a peripheral nerve trunk or nerve root is subjected to injury, compression, inflammation or ischemia, resulting in reduced physical capabilities of the peripheral nervous system. Although pharmacological treatments provide mild symptomatic relief in the short term, they are not without side effects.
Neurostimulation techniques may be an effective treatment option for peripheral brachial plexus neuropathies. Some of these procedures are transcutaneous electrical nerve stimulation (TENS) or percutaneous electrical nerve stimulation (PENS). Although some case series have documented a positive effect in relation to ultrasound-guided PENS for subjects with subacromial pain syndrome or postsurgical pain, the lack of studies, to our knowledge, analyzing the effects of percutaneous electrical nerve stimulation, in relation to pain and paresthesias in subjects with brachial plexus neuropathy, warrants investigation for this goal.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with upper limb neural symptomatology between 18 and 60 years of age, presenting two or more of the following conditions:
- •Paresthesias in any territory of the shoulder girdle, arm or hand
- •Pain at rest in any territory of the upper extremity.
- •Pain at rest in any upper extremity territory
- •Sensations of electric shock in any territory of the shoulder girdle, arm or hand.
- •Allodynia or cutaneous hyperalgesia in any territory of the shoulder girdle, arm or hand.
排除标准
- •Less than 2 weeks of evolution
- •Fracture in the affected upper extremity
- •Suffering from another joint disorder such as osteoarthritis or rheumatic disease
- •Suffering from generalized neuropathies due to neuromuscular disease or medication
- •Inability to understand instructions or sign informed consent.
- •Wearing a pacemaker or any electrical device implanted in the body
- •Aversion or fear of needles
- •Pregnant.
结局指标
主要结局
Pain Detect Scale
时间窗: 10 minutes
Screening questionnaire for neuropathic pain. This scale consists of a section dedicated to pain intensity and another that is responsible for assessing the qualitative aspect of pain, i.e., identifying whether the pain is of neuropathic characteristics. In the total of this scale the maximum possible score is 38 points and the minimum -1. For screening purposes, a score less than or equal to 12 is considered an unlikely neuropathic component. A score greater than or equal to 19 concludes that the neurological component in pain is probable.
Lanss Scale
时间窗: 10 minutes
Useful to identify patients with a pain experience dominated by neuropathic mechanisms. It is based on the analysis of sensory description and exploration of sensory dysfunction at the patient's bedside. It consists of 7 items and is scored from 0 to 24. At a score of less than 12, the neuropathic component is considered unlikely. A score greater than or equal to 12 is considered probable neuropathic pain. It is a validated scale for patients with neuropathic pain.
Numerical Pain Rating Scale (NPRS)
时间窗: 1 minute
A unique 11-point numerical scale validated in patients with various painful conditions. Data obtained through NPRS are easily documented, intuitively interpretable, and meet regulatory requirements for pain assessment and documentation. This scale is reliable and validated for assessing patients with pain20. Score 0 corresponds to "no pain" and score 10 corresponds to "maximum possible pain". In this study, patients were asked to mark their maximum pain detected in the last week (NPRS Max) and their minimum pain detected in the last week (NPRS Min).
次要结局
- Neural stress test(5 minutes)
- DASH scale(5 minutes)
- Thermography(10 minutes)
研究者
Josue Fernandez Carnero
Principal Investigator
Universidad Rey Juan Carlos