Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Observational Cohort Study of Chronic Low Back Pain

This study is ongoing, but not recruiting participants.
Harvard Medical School
Beth Israel Deaconess Medical Center
Information provided by (Responsible Party):
Julie E. Buring, Brigham and Women's Hospital Identifier:
First received: May 12, 2011
Last updated: November 11, 2014
Last verified: November 2014

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 150 Osher Clinical Center (OCC) patients with chronic low back pain (CLBP) compared with a comparison group of 150 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.

Back Pain Lower Back Chronic

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Use and Effectiveness of a Model Integrative Care Clinic in an Academic Hospital: Study II - Observational Cohort Study of Chronic Low Back Pain

Resource links provided by NLM:

Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Change in functional disability related to low back pain [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Measured by change in Modified Roland Morris disability scale (0-23 points)

  • Change in Bothersomeness of pain [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Measured by change in bothersomeness scale (On a scale of 0-10)

Secondary Outcome Measures:
  • Cost-effectiveness of integrative care for chronic low back pain [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Measured by utilization of health care services and productivity in the workplace

Estimated Enrollment: 300
Study Start Date: February 2012
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
OCC Patients
Patients being treated for chronic low back pain at the Osher Clinical Center of Brigham and Women's Hospital
Patients being treated for chronic low back pain at Brigham and Women's Hospital, other than at Osher Clinical Center


Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The CLBP patients will be identified from two different sources at Brigham and Women's Hospital (BWH): those coming to be treated at the OCC, and those coming to non-OCC physician providers at BWH (comparison group).


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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01355237

United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Harvard Medical School
Beth Israel Deaconess Medical Center
Principal Investigator: Julie E Buring, ScD Brigham and Women's Hospital
  More Information

No publications provided

Responsible Party: Julie E. Buring, Principal Investigator, Brigham and Women's Hospital Identifier: NCT01355237     History of Changes
Other Study ID Numbers: 1R01AT005065-01A1-2
Study First Received: May 12, 2011
Last Updated: November 11, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
Complementary and alternative medicine (CAM)

Additional relevant MeSH terms:
Back Pain
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms processed this record on February 27, 2015