Clinical trial NCT02159677: Electrical Impedance Myography of Neck and Low Back Pain
Official title: Electrical Impedance Myography for the Assessment of Neck and Low Back Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low Back Pain
Neck Pain
Keywords: EIM
Lead sponsor: Skulpt, Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2014-06-10
Enrollment: 178
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Neck and Low Back Pain Subjects

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.


Eligibility 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

Primary outcomes:
measure: Electrical Impedance Myography (EIM)
timeFrame: Screening Visit
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: New England Baptist Hospital
state: Massachusetts
city: Boston
country: United States
facility: Skulpt, Inc.
state: Massachusetts
Study officials:
References: