Low Back PainNCT01401660
Study of Low Back Pain Using CERSR® Imaging Technology
An observational study of Low Back Pain, run by Verium Diagnostics, Inc. at 2 sites in United States.
Trial summary
The purpose of this research study is to measure with CERSR® (Computerized Electrophysiological Reconstruction of the Spinal Regions) the electrical signals made by the muscles in the lower back 1) when the subject has no low back pain 2) during the time low back pain begins, or 3) during the treatment and resolution… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Physical Therapy
- How many people
- 290 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2011to not given
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The subjects will be selected from employees of Summa Health System. Current employees as well as new hires will be eligible to participate in the study.
Who may be able to join
- Male and female employees of the study center.
- Between the ages of 18 and 70 years.
- Current employees as well as new hires.
Who cannot join
- 1. Low back pain.
- Low back pain due to fracture, tumor, infection, cauda equina, severe neurological deficit.
- Pregnant.
- Sensitivity to isopropyl alcohol used to prepare the low back surface.
- Inability to complete the required collection positions for the CERSR® scan.
- Inability or unwillingness to adhere to the protocol and follow-up schedule.
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- Anyone under care of a physician for active liability or workman compensation cases.
- Anyone who has had an open spinal procedure in the last three months.
- Anyone who has undergone spine injections within the last two months.
- Low back pain due to fracture, tumor, infection, cauda equina, severe neurological deficit
- Pregnant.
- Sensitivity to isopropyl alcohol used to prepare the low back surface.
- Inability to complete the required collection positions for the CERSR scan.
- Inability or unwillingness to adhere to the protocol and follow-up schedule.
- Anyone under care of a physician for active liability or workman compensation cases.
- Anyone who has had an open spinal procedure in the last three months.
- Anyone who has undergone spine injections within the last two months.
- Anyone who is currently undergoing physical therapy or chiropractic treatments.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Summa Center for Clinical Trials
Akron, Ohio, 44304-1619
Summa St. Thomas Hospital
Akron, Ohio, 44310-3110
About this study
Official title: Observational Study of the Electrophysiological Course of Low Back Pain Using CERSR® Imaging Technology
The purpose of this research study is to measure with CERSR® (Computerized Electrophysiological Reconstruction of the Spinal Regions) the electrical signals made by the muscles in the lower back 1) when the subject has no low back pain 2) during the time low back pain begins, or 3) during the treatment and resolution of the low back pain, and 4) to study the changes which take place in these muscles as the pain improves with physical therapy treatment as an intervention. The hypotheses to be tested are 1) The CERSR® scan parameters for normal (pain-free) subjects are different from those of subjects with low back pain. 2) CERSR® scan aids the physician in determining a directed physical therapy treatment which leads to relief of low back pain following no more than eight weeks of physical therapy, as measured by relief of pain using a Visual Analog Scale and symptom improvement as measured using the Oswestry Disability Index.
Read the detailed description
The purpose of this research study is to measure with CERSR® (Computerized Electrophysiological Reconstruction of the Spinal Regions) the electrical signals made by the muscles in the lower back 1) when the subject has no low back pain 2) during the time low back pain begins, or 3) during the treatment and resolution of the low back pain, and 4) to study the changes which take place in these muscles as the pain improves with physical therapy treatment as an intervention. The hypotheses to be tested are 1) The CERSR® scan parameters for normal (pain-free) subjects are different from those of subjects with low back pain. 2) CERSR® scan aids the physician in determining a directed physical therapy treatment which leads to relief of low back pain following no more than eight weeks of physical therapy, as measured by relief of pain using a Visual Analog Scale and symptom improvement as measured using the Oswestry Disability Index.
- Conditions
- Low Back Pain
- Being tested
- Physical Therapy
- Keywords
- low back pain
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical TherapyOther
The physician will complete a physical exam as well as analyze a completed CERSR® scan study to determine the root cause of the low back pain. The physician will then prescribe a targeted physical therapy regime to address the cause of the low back pain.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Subjects who do not currently have low back pain. | |
| Group B | Subjects who have low back pain at the time of the study, and who are currently being treated or have been previously treated for their low back pain and do not wish to receive further treatment for their pain. | |
| Group C | Subjects who have low back pain at the time of the study, and wish to receive physical therapy to reduce their low back pain. Receives: Other: Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Pain Visual Analog Scale
The subjects will complete a form indicating their pain level upon enrollment. Subjects will then be scanned again at four weeks and at eight weeks. At the time of the scan subjects will also be asked to complete a follow up VAS. Upon completion of the study the change in VAS scores will be analyzed.
Measured: Upon enrollment (day 1 - baseline) and four weeks and eight weeks
Secondary outcomes (1)
Change from Baseline Oswestry Disability Index (ODI)
The subjects will complete the Oswestry Disability Index upon enrollment. Subjects will then be scanned again at four weeks and at eight weeks. At the time of the scan subjects will also be asked to complete a follow up ODI. Upon completion of the study the change in ODI scores will be analyzed.
Measured: Upon enrollment (day 1 - baseline) and at four weeks and at eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2011 (estimated)
- Study startMay 2011
Why it stopped: Principal Investigator withdrew from the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 290 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Verium Diagnostics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Nilesh Shah, M.D., Principal investigator, Summa Health Systems
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01401660
- Sponsor's protocol ID
- SMI-2010-002
- Other IDs
- RP# 11002
- Status last verified
- Jul 2011
- First submitted
- 29 Mar 2011
- Last updated
- 1 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Finneran MT, Mazanec D, Marsolais ME, Marsolais EB, Pease WS. Large-array surface electromyography in low back pain: a pilot study. Spine (Phila Pa 1976). 2003 Jul 1;28(13):1447-54. doi: 10.1097/01.BRS.0000067565.16832.B9.
PubMed 12838104
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of the Electrophysiological Course of Low Back Pain Using CERSR® Imaging Technology
- ClinicalTrials.gov ID
- NCT01401660
- Acronym / sponsor ID
- SMI-2010-002
- Conditions
- Low Back Pain
- Keywords
- low back pain
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Principal Investigator withdrew from the study.
- Enrolment
- 290 participants (estimated)
- Lead sponsor
- Verium Diagnostics, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2011
- First posted
- 25 Jul 2011 (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 research study is to measure with CERSR® (Computerized Electrophysiological Reconstruction of the Spinal Regions) the electrical signals made by the muscles in the lower back 1) when the subject has no low back pain 2) during the time low back pain begins, or 3) during the treatment and resolution of the low back pain, and 4) to study the changes which take place in these muscles as the pain improves with physical therapy treatment as an intervention. The hypotheses to be tested are 1) The CERSR® scan parameters for normal (pain-free) subjects are different from those of subjects with low back pain. 2) CERSR® scan aids the physician in determining a directed physical therapy treatment which leads to relief of low back pain following no more than eight weeks of physical therapy, as measured by relief of pain using a Visual Analog Scale and symptom improvement as measured using the Oswestry Disability Index.
Detailed description
The purpose of this research study is to measure with CERSR® (Computerized Electrophysiological Reconstruction of the Spinal Regions) the electrical signals made by the muscles in the lower back 1) when the subject has no low back pain 2) during the time low back pain begins, or 3) during the treatment and resolution of the low back pain, and 4) to study the changes which take place in these muscles as the pain improves with physical therapy treatment as an intervention. The hypotheses to be tested are 1) The CERSR® scan parameters for normal (pain-free) subjects are different from those of subjects with low back pain. 2) CERSR® scan aids the physician in determining a directed physical therapy treatment which leads to relief of low back pain following no more than eight weeks of physical therapy, as measured by relief of pain using a Visual Analog Scale and symptom improvement as measured using the Oswestry Disability Index.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | – | –Subjects who do not currently have low back pain. |
| Group B | – | –Subjects who have low back pain at the time of the study, and who are currently being treated or have been previously treated for their low back pain and do not wish to receive further treatment for their pain. |
| Group C | – | Other: Physical TherapySubjects who have low back pain at the time of the study, and wish to receive physical therapy to reduce their low back pain. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The subjects will be selected from employees of Summa Health System. Current employees as well as new hires will be eligible to participate in the study.
Key inclusion criteria (3 listed)
- Male and female employees of the study center.
- Between the ages of 18 and 70 years.
- Current employees as well as new hires.
Key exclusion criteria (18 listed)
- 1. Low back pain.
- Low back pain due to fracture, tumor, infection, cauda equina, severe neurological deficit.
- Pregnant.
- Sensitivity to isopropyl alcohol used to prepare the low back surface.
- Inability to complete the required collection positions for the CERSR® scan.
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 |
|---|---|---|
| Physical TherapyThe physician will complete a physical exam as well as analyze a completed CERSR® scan study to determine the root cause of the low back pain. The physician will then prescribe a targeted physical therapy regime to address the cause of the low back pain. | Other | Group C |
Primary outcome
Change from Baseline in Pain Visual Analog Scale
Time frame: Upon enrollment (day 1 - baseline) and four weeks and eight weeks
The subjects will complete a form indicating their pain level upon enrollment. Subjects will then be scanned again at four weeks and at eight weeks. At the time of the scan subjects will also be asked to complete a follow up VAS. Upon completion of the study the change in VAS scores will be analyzed.
1 secondary outcome
Change from Baseline Oswestry Disability Index (ODI)
Time frame: Upon enrollment (day 1 - baseline) and at four weeks and at eight weeks
Results and safety
The study was stopped early (reason given: Principal Investigator withdrew from the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2011.
- Background: PubMed 12838104Finneran MT, Mazanec D, Marsolais ME, Marsolais EB, Pease WS. Large-array surface electromyography in low back pain: a pilot study. Spine (Phila Pa 1976). 2003 Jul 1;28(13):1447-54. doi: 10.1097/01.BRS.0000067565.16832.B9.
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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.
Nilesh Shah, M.D. principal investigator
Summa Health Systems
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, run by Verium Diagnostics, 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 3 inclusion and 18 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: stopped early, as of the sponsor's last update on 1 Aug 2011. 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 was stopped early (reason given: Principal Investigator withdrew from the study.). Results are not available in the source record.
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?
Change from Baseline in Pain Visual Analog Scale (time frame: Upon enrollment (day 1 - baseline) and four weeks and eight weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01401660, which also lists 1 linked publication.
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 1 Aug 2011.