Electrical Impedance Myography of Neck and Low Back Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

178 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-11-30

Brief Summary

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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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Detailed Description

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Conditions

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Low Back Pain Neck Pain

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

EIM Measurements

Intervention Type DEVICE

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.

EIM Measurements

Intervention Type DEVICE

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.

EIM Measurements

Intervention Type DEVICE

Undiagnosed Lower Back or Neck Pain Subjects

Subjects aged 21-80 years with a major complaint of lower back or neck pain.

EIM Measurements

Intervention Type DEVICE

Interventions

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EIM Measurements

Intervention Type DEVICE

Eligibility Criteria

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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)

* 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

* Age 21 to 80 years old
* Major complaint of lower back or neck pain

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:

* 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
3. Undiagnosed Lower Back or Neck Pain Subjects:

* 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

Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes