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Electrical Impedance Myography of Neck and Low Back Pain

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02159677
Acronym
EIM
Enrollment
178
Registered
2014-06-10
Start date
2014-01-31
Completion date
2015-11-30
Last updated
2016-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain, Neck Pain

Keywords

EIM

Brief summary

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.

Interventions

Sponsors

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
CollaboratorNIH
Skulpt, Inc.
Lead SponsorINDUSTRY

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

1. 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 2. 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

Design outcomes

Primary

MeasureTime frameDescription
Electrical Impedance Myography (EIM)Screening VisitSubjects 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026