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

Skulpt, Inc.2 sites in 1 country178 target enrollmentJanuary 2014

ConditionsLow Back Pain Neck Pain

Overview

Phase: N/A
Intervention: Not specified
Conditions: Low Back Pain
Sponsor: Skulpt, Inc.
Enrollment: 178
Locations: 2
Primary Endpoint: Electrical Impedance Myography (EIM)
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2014

End Date

November 2015

Last Updated

10 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Skulpt, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

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.