Electrical Impedance Myography of Neck and Low Back Pain
Completed
Conditions studied: Low Back Pain, Neck Pain
In brief
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.
Key facts
- Study ID
- NCT02159677
- Run by
- Skulpt, Inc.
- People needed
- 178
- Starts
- 2014-01-01
- Expected to finish
- 2015-11-01
- Last updated by the study team
- 2016-01-21
Who can join
Age: 21 and older, up to 80. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- New England Baptist Hospital — Boston, Massachusetts, United States
- Skulpt, Inc. — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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