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| ID | Type | Description | Link |
|---|---|---|---|
| 2R44AR064142 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Subjects | 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. |
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| Radiculopathy Subjects | Subjects aged 21-80 years with a history consistent with radiculopathy based on clinical, radiologic, and standard electrophysiological criteria, as determined by spine expert. |
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| Musculoskeletal Back Pain Subjects | 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. |
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| Undiagnosed Lower Back or Neck Pain Subjects | Subjects aged 21-80 years with a major complaint of lower back or neck pain. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EIM Measurements | Device |
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| 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 |
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Radiculopathy Subjects:
Inclusion Criteria:
Exclusion Criteria:
Musculoskeletal Back Pain Subjects:
Inclusion Criteria:
Exclusion Criteria:
Undiagnosed Lower Back or Neck Pain Subjects:
Inclusion Criteria:
Exclusion Criteria:
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Neck and Low Back Pain Subjects
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New England Baptist Hospital | Boston | Massachusetts | 02120 | United States | ||
| Skulpt, Inc. |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D019547 | Neck Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| Boston |
| Massachusetts |
| 02210 |
| United States |
| D013568 |
| Pathological Conditions, Signs and Symptoms |