Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02159677
Recruitment Status : Completed
First Posted : June 10, 2014
Last Update Posted : January 21, 2016
Sponsor:
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
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.

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

Layout table for study information
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

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



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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02159677


Locations
Layout table for location information
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)
Additional Information:

Layout table for additonal 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    Key Record Dates
Last Update Posted: January 21, 2016
Last Verified: January 2016
Keywords provided by Skulpt, Inc.:
EIM
Additional relevant MeSH terms:
Layout table for MeSH terms
Back Pain
Low Back Pain
Neck Pain
Pain
Neurologic Manifestations