Electrical Impedance Myography of Neck and Low Back Pain (EIM)

Skulpt

Status: Completed

Conditions: Neck Pain; Low Back Pain

Treatments: Device: EIM Measurements

Study type: Observational

Funder types: Industry; NIH

Identifiers

NCT02159677

2R44AR064142 (U.S. NIH Grant/Contract)

LBP-001-2012

Details and patient eligibility

About

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.

Enrollment: 178 patients

Sex: All

Ages: 21 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

   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

3. 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

Trial design

178 participants in 4 patient groups

Healthy Subjects

Description:

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.

Treatment:

Device: EIM Measurements

Radiculopathy Subjects

Description:

Subjects aged 21-80 years with a history consistent with radiculopathy based on clinical, radiologic, and standard electrophysiological criteria, as determined by spine expert.

Treatment:

Device: EIM Measurements

Musculoskeletal Back Pain Subjects

Description:

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.

Treatment:

Device: EIM Measurements

Undiagnosed Lower Back or Neck Pain Subjects

Description:

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

Treatment:

Device: EIM Measurements