Electrical Impedance Myography of Neck and Low Back Pain

NCT02159677 | Completed DMC

• 2 other identifiers: LBP-001-20122R44AR064142
• Study Type: observational
• Target: 178
• Locations: 1 country
• Sites: 2

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.

Conditions

Low Back Pain; Neck Pain

Keywords

EIM

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

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

Interventions

EIM Measurements DEVICE

Healthy Subjects; Musculoskeletal Back Pain Subjects; Radiculopathy Subjects; Undiagnosed Lower Back or Neck Pain Subjects

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Neck and Low Back Pain Subjects

You may qualify if:

• 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)

You may not qualify if:

• 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:
• 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
• 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:
• Age 21 to 80 years old
• Major complaint of lower back or neck pain

Sponsors & Collaborators

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

Study Sites (2)

New England Baptist Hospital

Boston, Massachusetts, 02120, United States

Location

Skulpt, Inc.

Boston, Massachusetts, 02210, United States

Location

MeSH Terms

Conditions

Low Back Pain; Neck Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2014
• First Posted: June 10, 2014
• Study Start: January 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: November 1, 2015
• Last Updated: January 21, 2016

Record last verified: 2016-01

Locations

US (2)