Electrical Impedance Myography of Neck and Low Back Pain

Low Back Pain Clinical Trial

— EIM  

Official title:

Electrical Impedance Myography for the Assessment of Neck and Low Back Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02159677
• Other study ID #: LBP-001-2012
• Secondary ID: 2R44AR064142
• Status: Completed
• Phase: N/A
• First received: June 6, 2014
• Last updated: January 20, 2016
• Start date: January 2014
• Est. completion date: November 2015

Study information

• Verified date: January 2016
• Source: Skulpt, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 178
• Est. completion date: November 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Neck Pain

Intervention

Device:
• EIM Measurements

Locations

Country	Name	City	State
United States	New England Baptist Hospital	Boston	Massachusetts
United States	Skulpt, Inc.	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Skulpt, Inc.	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No