Low Back PainEIMNCT02159677
Electrical Impedance Myography of Neck and Low Back Pain
An observational study of Low Back Pain and Neck Pain, run by Skulpt, Inc. at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain, Neck Pain
- What is being tested?
- EIM Measurements
- Type of treatment
- Medical device
- How many people
- 178 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2014to Nov 2015
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Neck and Low Back Pain Subjects
Who may be able to join
- 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)
- 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 21 to 80 years old
- Major complaint of lower back or neck pain
Who cannot join
- 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 under 21 or over 80
Show all 16Show fewer
- 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 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
New England Baptist Hospital
Boston, Massachusetts, 02120
Skulpt, Inc.
Boston, Massachusetts, 02210
About this study
Official title: Electrical Impedance Myography for the Assessment of Neck and Low Back Pain
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
- Being tested
- EIM Measurements
- Keywords
- EIM
- Medical subject headings
- Low Back Pain, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EIM MeasurementsDevice
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Device: EIM Measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Screening Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2014 (estimated)
- Study startJan 2014
- Primary completionAug 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 178 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Skulpt, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02159677
- Sponsor's protocol ID
- LBP-001-2012
- Other IDs
- 2R44AR064142
- Acronym
- EIM
- Status last verified
- Jan 2016
- First submitted
- 6 Jun 2014
- Last updated
- 21 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrical Impedance Myography for the Assessment of Neck and Low Back Pain
- ClinicalTrials.gov ID
- NCT02159677
- Acronym / sponsor ID
- EIM / LBP-001-2012
- Conditions
- Low Back Pain, Neck Pain
- Keywords
- EIM
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Skulpt, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- Jan 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 10 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy Subjects | – | Device: EIM MeasurementsHealthy 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. |
| Radiculopathy Subjects | – | Device: EIM MeasurementsSubjects aged 21-80 years with a history consistent with radiculopathy based on clinical, radiologic, and standard electrophysiological criteria, as determined by spine expert. |
| Musculoskeletal Back Pain Subjects | – | Device: EIM MeasurementsSubjects 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. |
| Undiagnosed Lower Back or Neck Pain Subjects | – | Device: EIM MeasurementsSubjects aged 21-80 years with a major complaint of lower back or neck pain. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Neck and Low Back Pain Subjects
Key inclusion criteria (6 listed)
- Age 21 to 80 years old
- Major complaint of lower back or neck pain
Key exclusion criteria (16 listed)
- Musculoskeletal Back Pain Subjects:
- Undiagnosed Lower Back or Neck Pain Subjects:
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EIM Measurements | Device | Healthy Subjects, Musculoskeletal Back Pain Subjects, Radiculopathy Subjects, Undiagnosed Lower Back or Neck Pain Subjects |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain and Neck Pain, run by Skulpt, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electrical Impedance Myography (EIM) (time frame: Screening Visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2016.