NCT Number: NCT02159677
Electrical Impedance Myography of Neck and Low Back Pain
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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Conditions
Age range
21 year–80 year
Sex eligibility
All sexes
Study type
Observational
Primary location
New England Baptist Hospital, Boston, Massachusetts, United States
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
- 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
Treatment and study plan
Primary outcomes
-
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.
Sponsors and collaborators
Lead sponsor
Skulpt, Inc.
Industry
Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Registry information
Official study title
Electrical Impedance Myography for the Assessment of Neck and Low Back Pain
Acronym: EIM
Important dates
- Study start
- 2014
- Primary completion
- 2015
- Study completion
- 2015
- First posted
- Jun 10, 2014
- Registry last updated
- Jan 21, 2016
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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