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Study of Low Back Pain Using CERSR® Imaging Technology

29 juli 2011 bijgewerkt door: Verium Diagnostics, Inc.

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.

Studie Overzicht

Toestand

Beëindigd

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Verwacht)

290

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Ohio
      • Akron, Ohio, Verenigde Staten, 44304-1619
        • Summa Center for Clinical Trials
      • Akron, Ohio, Verenigde Staten, 44310-3110
        • Summa St. Thomas Hospital

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 70 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

Inclusion Criteria Groups A, B and C:

  1. Male and female employees of the study center.
  2. Between the ages of 18 and 70 years.
  3. Current employees as well as new hires.

Exclusion Criteria Group A:

1. Low back pain.

Exclusion Criteria Group B:

  1. Low back pain due to fracture, tumor, infection, cauda equina, severe neurological deficit.
  2. Pregnant.
  3. Sensitivity to isopropyl alcohol used to prepare the low back surface.
  4. Inability to complete the required collection positions for the CERSR® scan.
  5. Inability or unwillingness to adhere to the protocol and follow-up schedule.
  6. Anyone under care of a physician for active liability or workman compensation cases.
  7. Anyone who has had an open spinal procedure in the last three months.
  8. Anyone who has undergone spine injections within the last two months.

Exclusion Criteria Group C:

  1. Low back pain due to fracture, tumor, infection, cauda equina, severe neurological deficit
  2. Pregnant.
  3. Sensitivity to isopropyl alcohol used to prepare the low back surface.
  4. Inability to complete the required collection positions for the CERSR scan.
  5. Inability or unwillingness to adhere to the protocol and follow-up schedule.
  6. Anyone under care of a physician for active liability or workman compensation cases.
  7. Anyone who has had an open spinal procedure in the last three months.
  8. Anyone who has undergone spine injections within the last two months.
  9. Anyone who is currently undergoing physical therapy or chiropractic treatments.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
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.
Ander: Physical Therapy
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change from Baseline in Pain Visual Analog Scale
Tijdsspanne: 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.
Upon enrollment (day 1 - baseline) and four weeks and eight weeks

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change from Baseline Oswestry Disability Index (ODI)
Tijdsspanne: Upon enrollment (day 1 - baseline) and at four weeks and at eight weeks
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.
Upon enrollment (day 1 - baseline) and at four weeks and at eight weeks

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Verium Diagnostics, Inc.

Onderzoekers

  • Hoofdonderzoeker: Nilesh Shah, M.D., Summa Health Systems

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 mei 2011

Studieregistratiedata

Eerst ingediend

29 maart 2011

Eerst ingediend dat voldeed aan de QC-criteria

21 juli 2011

Eerst geplaatst (Schatting)

25 juli 2011

Updates van studierecords

Laatste update geplaatst (Schatting)

1 augustus 2011

Laatste update ingediend die voldeed aan QC-criteria

29 juli 2011

Laatst geverifieerd

1 juli 2011

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • SMI-2010-002
  • RP# 11002 (Andere identificatie: Summa Health Systems IRB)

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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