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

• ClinicalTrials.gov Identifier: NCT02159677
• Recruitment Status: Completed
• First Posted: June 10, 2014
• Last Update Posted: January 21, 2016
• Sponsor: Skulpt, Inc.
• Collaborator: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
• Information provided by (Responsible Party): Skulpt, Inc.

Study Description

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.

Condition or disease	Intervention/treatment
Low Back Pain; Neck Pain	Device: EIM Measurements

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 178 participants
• Observational Model: Case-Control
• Time Perspective: Cross-Sectional
• Target Follow-Up Duration: 1 Day
• Official Title: Electrical Impedance Myography for the Assessment of Neck and Low Back Pain
• Study Start Date: January 2014
• Actual Primary Completion Date: August 2015
• Actual Study Completion Date: November 2015

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: 21 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Probability Sample

Study Population

Neck and Low Back Pain Subjects

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

Contacts and Locations

Locations

United States, Massachusetts

New England Baptist Hospital

Boston, Massachusetts, United States, 02120

Skulpt, Inc.

Boston, Massachusetts, United States, 02210

Sponsors and Collaborators

Skulpt, Inc.

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

More Information

Additional Information:

• Responsible Party: Skulpt, Inc.
• ClinicalTrials.gov Identifier: NCT02159677
• Other Study ID Numbers: LBP-001-2012; 2R44AR064142 ( U.S. NIH Grant/Contract )
• First Posted: June 10, 2014
• Last Update Posted: January 21, 2016
• Last Verified: January 2016

Keywords provided by Skulpt, Inc.:

EIM

Additional relevant MeSH terms:

Back Pain; Low Back Pain; Neck Pain; Pain; Neurologic Manifestations