Observational Cohort Study of Chronic Low Back Pain

Study Overview
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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.

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

Conditions
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Back Pain Lower Back Chronic

Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| OCC Patients<br>Patients being treated for chronic low back pain at the Osher Clinical Center of Brigham and Women's Hospital | |
| Comparison<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in functional disability related to low back pain | Measured by change in Modified Roland Morris disability scale (0-23 points) | 6 months | 
| Change in Bothersomeness of pain | 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 | Measured by utilization of health care services and productivity in the workplace | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Complementary and alternative medicine (CAM)