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OpenTrials
Completed

NCT Number: NCT02159677

Electrical Impedance Myography 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.

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Key information

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

New England Baptist Hospital, Boston, Massachusetts, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • 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
  • 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
  • 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

Treatment and study plan

EIM Measurements

Device

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Skulpt, Inc.

Industry

Collaborators

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Registry information

Official study title

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

Acronym: EIM

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 10, 2014
Registry last updated
Jan 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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