Electrical Impedance Myography of Neck and Low Back Pain (EIM)
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ClinicalTrials.gov Identifier: NCT02159677 |
Recruitment Status :
Completed
First Posted : June 10, 2014
Last Update Posted : January 21, 2016
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Condition or disease | Intervention/treatment |
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Low Back Pain Neck Pain | Device: EIM Measurements |
Study Type : | Observational [Patient Registry] |
Actual Enrollment : | 178 participants |
Observational Model: | Case-Control |
Time Perspective: | Cross-Sectional |
Target Follow-Up Duration: | 1 Day |
Official Title: | Electrical Impedance Myography for the Assessment of Neck and Low Back Pain |
Study Start Date : | January 2014 |
Actual Primary Completion Date : | August 2015 |
Actual Study Completion Date : | November 2015 |
Group/Cohort | Intervention/treatment |
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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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Device: EIM Measurements |
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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Device: EIM Measurements |
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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Device: EIM Measurements |
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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Device: EIM Measurements |
- Electrical Impedance Myography (EIM) [ Time Frame: 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.

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Ages Eligible for Study: | 21 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Probability Sample |
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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
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02159677
United States, Massachusetts | |
New England Baptist Hospital | |
Boston, Massachusetts, United States, 02120 | |
Skulpt, Inc. | |
Boston, Massachusetts, United States, 02210 |
Responsible Party: | Skulpt, Inc. |
ClinicalTrials.gov Identifier: | NCT02159677 |
Other Study ID Numbers: |
LBP-001-2012 2R44AR064142 ( U.S. NIH Grant/Contract ) |
First Posted: | June 10, 2014 Key Record Dates |
Last Update Posted: | January 21, 2016 |
Last Verified: | January 2016 |
EIM |
Back Pain Low Back Pain Neck Pain Pain Neurologic Manifestations |