NCT02159677已完成不适用
Electrical Impedance Myography for the Assessment of Neck and Low Back Pain
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Skulpt, Inc.
- 入组人数
- 178
- 试验地点
- 2
- 主要终点
- Electrical Impedance Myography (EIM)
研究概览
简要总结
The purpose of this study is to assess neck and low back pain using Electrical Impedance Myography (EIM) in order to develop an algorithm to aid primary care providers (PCPs) in the diagnosis of neck/back pain. Secondary goals include the refinement of EIM technology and associated software of ease-of-use and interpretation by PCPs and staff.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 21-80 years old
- •History consistent with radiculopathy based on clinical, radiologic, and standard electrophysiological criteria, as determined by spine expert (Dr. John Keel)
排除标准
- •Age under 21 or over 80
- •History of a generalized neuromuscular condition, except for mild polyneuropathy or common mononeuropathies (e.g., carpal tunnel syndrome, ulnar neuropathy at the elbow)
- •History of moderate-to-severe ongoing medical conditions producing generalized disability, such as advanced cardiac or renal disease
- •Metal spine implants of any type
- •Musculoskeletal Back Pain Subjects:
- •Inclusion Criteria:
- •Age 21 to 80 years old
- •Low back or neck pain without evidence to suggest neuropathic component; i.e., without radiation of pain, sensory loss or weakness
- •Exclusion Criteria:
- •Age under 21 or over 80
- •History of sciatica or cervical radiculopathy
- •History of a generalized neuromuscular condition, except for mild polyneuropathy or common mononeuropathies (e.g., carpal tunnel syndrome, ulnar neuropathy at the elbow)
- •History of moderate-to-severe ongoing medical conditions producing generalized disability, such as advanced cardiac or renal disease
- •Metal spine implants of any type
- •Undiagnosed Lower Back or Neck Pain Subjects:
- •Inclusion Criteria:
- •Age 21 to 80 years old
- •Major complaint of lower back or neck pain
- •Exclusion Criteria:
- •Age under 21 or over 80
- •Recent (<6 month) history of similar symptoms that has been evaluated
- •History of a generalized neuromuscular condition, except for mild polyneuropathy or common mononeuropathies (e.g., carpal tunnel syndrome, ulnar neuropathy at the elbow)
- •History of moderate-to-severe ongoing medical conditions producing generalized disability, such as advanced cardiac or renal disease
- •Metal spine implants of any type
结局指标
主要结局
Electrical Impedance Myography (EIM)
时间窗: Screening Visit
Subjects will undergo EIM testing on the following muscle groups: deltoid, biceps, brachioradialis, triceps, forearm flexors, neck paraspinal muscles, lumbar paraspinal muscles, vastus lateralis, vastus medials, tibialis anterior, extensor hallucis, medial gastrocnemius.
次要结局
未报告次要终点
研究者
研究点 (2)
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