Observational Cohort Study of Chronic Low Back Pain


This research study is being done to understand the outcomes of back pain treatment and costs associated with it in an academic hospital outpatient setting. The investigators will conduct a prospective observational cohort study to assess the clinical outcomes and utilization of health care services of 175 Osher Clinical Center (OCC) patients with chronic low back pain (CLBP) compared with a comparison group of 175 non-OCC CLBP patients treated within Brigham and Women's Hospital. Outcomes will include assessment of functional status, symptom relief, satisfaction with care, health-related quality of life, and worker productivity, and will be measured in person at baseline, and by phone by an interviewer blinded to cohort group at 3, 6, and 12 months.

Full Title of Study: “Use and Effectiveness of a Model Integrative Care Clinic in an Academic Hospital: Study II – Observational Cohort Study of Chronic Low Back Pain”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: April 2015

Arms, Groups and Cohorts

  • OCC Patients
    • Patients being treated for chronic low back pain at the Osher Clinical Center of Brigham and Women’s Hospital
  • Comparison
    • Patients being treated for chronic low back pain at Brigham and Women’s Hospital, other than at Osher Clinical Center

Clinical Trial Outcome Measures

Primary Measures

  • Change in functional disability related to low back pain
    • Time Frame: 6 months
    • Measured by change in Modified Roland Morris disability scale (0-23 points)
  • Change in Bothersomeness of pain
    • Time Frame: 6 months
    • Measured by change in bothersomeness scale (On a scale of 0-10)

Secondary Measures

  • Cost-effectiveness of integrative care for chronic low back pain
    • Time Frame: 12 months
    • Measured by utilization of health care services and productivity in the workplace

Participating in This Clinical Trial

Inclusion Criteria

  • 3 months or more of chronic low back pain or 6 months or more of intermittent low back pain OR
  • having at least one of a list of ICD-9 diagnostic codes for uncomplicated low back pain
  • having two or more visits for back pain within the past two years; one of these visits must have happened within the past year (as a screening marker of chronicity)

Exclusion Criteria

  • under the age of 21
  • unable to understand English
  • have complicated low back pain (e.g. history of back pain related to cancer, fracture, or infection)
  • unable to participate in the phone follow-up for the next one-year period.

Gender Eligibility: All

Minimum Age: 21 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Brigham and Women’s Hospital
  • Collaborator
    • Harvard Medical School
  • Provider of Information About this Clinical Study
    • Principal Investigator: Julie E. Buring, Principal Investigator – Brigham and Women’s Hospital
  • Overall Official(s)
    • Julie E Buring, ScD, Principal Investigator, Brigham and Women’s Hospital

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