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

Electrical Impedance Myography for the Assessment 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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain; Neck Pain
• Intervention / Treatment: Device: EIM Measurements

• Study Type: Observational
• Enrollment (Actual): 178

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02120
      • New England Baptist Hospital
    • Boston, Massachusetts, United States, 02210
      • Skulpt, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Neck and Low Back Pain Subjects

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: EIM Measurements
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.	Device: EIM Measurements
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.	Device: EIM Measurements
Undiagnosed Lower Back or Neck Pain Subjects; Subjects aged 21-80 years with a major complaint of lower back or neck pain.	Device: EIM Measurements

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Electrical Impedance Myography (EIM)	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.	Screening Visit

Collaborators and Investigators

• Sponsor: Skulpt, Inc.
• Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: June 6, 2014
• First Submitted That Met QC Criteria: June 6, 2014
• First Posted (Estimate): June 10, 2014

Study Record Updates

• Last Update Posted (Estimate): January 21, 2016
• Last Update Submitted That Met QC Criteria: January 20, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: EIM
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain; Neck Pain
• Other Study ID Numbers: LBP-001-2012; 2R44AR064142 (U.S. NIH Grant/Contract)