NCT01401660

Brief 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 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
290

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2011

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 25, 2011

Completed
Last Updated

August 1, 2011

Status Verified

July 1, 2011

First QC Date

March 29, 2011

Last Update Submit

July 29, 2011

Conditions

Low Back Pain

Keywords

low back pain

Outcome Measures

Primary Outcomes (1)

  • 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.

    Upon enrollment (day 1 - baseline) and four weeks and eight weeks

Secondary Outcomes (1)

  • Change from Baseline Oswestry Disability Index (ODI)

    Upon enrollment (day 1 - baseline) and at four weeks and at eight weeks

Study Arms (3)

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.

Other: Physical Therapy

Interventions

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.

Group C

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

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

You may not qualify if:

  • \. 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.
  • 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.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Summa Center for Clinical Trials

Akron, Ohio, 44304-1619, United States

Location

Summa St. Thomas Hospital

Akron, Ohio, 44310-3110, United States

Location

Related Publications (1)

  • 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.

    PMID: 12838104BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Nilesh Shah, M.D.

    Summa Health Systems

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 29, 2011

First Posted

July 25, 2011

Study Start

May 1, 2011

Last Updated

August 1, 2011

Record last verified: 2011-07

Locations

US(2)