Observational Cohort Study of Chronic Low Back Pain

NCT ID: NCT01355237

Last Updated: 2017-06-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

309 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-02-29

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Back Pain Lower Back Chronic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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OCC Patients

Patients being treated for chronic low back pain at the Osher Clinical Center of Brigham and Women's Hospital

No interventions assigned to this group

Comparison

Patients being treated for chronic low back pain at Brigham and Women's Hospital, other than at Osher Clinical Center

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Harvard Medical School (HMS and HSDM)

OTHER

Sponsor Role collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Julie E. Buring

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Julie E Buring, ScD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

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Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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1R01AT005065-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1R01AT005065-01A1-2

Identifier Type: -

Identifier Source: org_study_id

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