Electrical Impedance Myography of Neck and Low Back Pain

Completed

• Conditions: Low Back Pain; Neck Pain
• Interventions: Device: EIM Measurements

• Registration Number: NCT02159677
• Lead Sponsor: Skulpt, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-06-06
• Study First Submitted QC: 2014-06-06
• Study First Posted: 2014-06-10
• Primary Completion: 2015-08
• Study Completion: 2015-11
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-20
• Last Update Posted: 2016-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 178

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Undiagnosed Lower Back or Neck Pain Subjects	EIM Measurements	Subjects aged 21-80 years with a major complaint of lower back or neck pain.
Healthy Subjects	EIM Measurements	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.
Radiculopathy Subjects	EIM Measurements	Subjects aged 21-80 years with a history consistent with radiculopathy based on clinical, radiologic, and standard electrophysiological criteria, as determined by spine expert.
Musculoskeletal Back Pain Subjects	EIM Measurements	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.

Primary Outcome Measures

Name	Time	Method
Electrical Impedance Myography (EIM)	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.

Trial Locations

Locations (2)

New England Baptist Hospital; 🇺🇸 Boston, Massachusetts, United States

Skulpt, Inc.; 🇺🇸 Boston, Massachusetts, United States