Observational Cohort Study of Chronic Low Back Pain

June 12, 2017 updated by: Julie E. Buring, Brigham and Women's Hospital

Use and Effectiveness of a Model Integrative Care Clinic in an Academic Hospital: Study II - 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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

309

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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).

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
6 months
Change in Bothersomeness of pain
Time Frame: 6 months
Measured by change in bothersomeness scale (On a scale of 0-10)
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Collaborators

Harvard Medical School (HMS and HSDM)
Beth Israel Deaconess Medical Center

Investigators

  • Principal Investigator: Julie E Buring, ScD, Brigham and Women's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

May 12, 2011

First Submitted That Met QC Criteria

May 16, 2011

First Posted (Estimate)

May 18, 2011

Study Record Updates

Last Update Posted (Actual)

June 14, 2017

Last Update Submitted That Met QC Criteria

June 12, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R01AT005065-01A1-2
  • 1R01AT005065-01A1 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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