Electrical Impedance Myography of Neck and Low Back Pain

Study Overview
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Brief Summary
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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.

Official Title
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Electrical Impedance Myography for the Assessment of Neck and Low Back Pain

Conditions
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Neck Pain, Low Back Pain

Intervention / Treatment
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* Device: EIM Measurements


Participation Criteria
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Eligibility Criteria
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Radiculopathy Subjects: Inclusion Criteria: 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) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy Subjects<br>Healthy subjects aged 21-80 years with no history of present or past disabling back or neck pain, sciatica, cervical radiculopathy, or any generalized neuromuscular condition except for mild polyneuropathy or common mononeuropathies (e.g. carpal tunnel syndrome, ulnar neuropathy at the elbow.) Additionally, subjects cannot have any history of any moderate-to-severe ongoing medical condition producing generalized disability, such as advanced cardiac or renal disease, or metal spine implants of any type. | Device: EIM Measurements<br> <br> |
| Radiculopathy Subjects<br>Subjects aged 21-80 years with a history consistent with radiculopathy based on clinical, radiologic, and standard electrophysiological criteria, as determined by spine expert. | Device: EIM Measurements<br> <br> |
| Musculoskeletal Back Pain Subjects<br>Subjects aged 21-80 years with low back or neck pain without evidence to suggest neuropathic component; i.e. without radiation of pain, sensory loss or weakness. | Device: EIM Measurements<br> <br> |
| Undiagnosed Lower Back or Neck Pain Subjects<br>Subjects aged 21-80 years with a major complaint of lower back or neck pain. | Device: EIM Measurements<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electrical Impedance Myography (EIM) | 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. | Screening Visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EIM