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Observational Cohort Study of Chronic Low Back Pain

Mass General Brigham logo

Mass General Brigham

Status

Completed

Conditions

Back Pain Lower Back Chronic

Study type

Observational

Funder types

Other

Identifiers

NCT01355237
1R01AT005065-01A1-2
1R01AT005065-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

309 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

309 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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