Observational Cohort Study of Chronic Low Back Pain

Completed

• Conditions: Back Pain Lower Back Chronic

• Registration Number: NCT01355237
• Lead Sponsor: Brigham and Women's Hospital

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2011-05-12
• Study First Submitted QC: 2011-05-16
• Study First Posted: 2011-05-18
• Study Start: 2012-02
• Primary Completion: 2015-04
• Study Completion: 2015-12
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-12
• Last Update Posted: 2017-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 309

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in functional disability related to low back pain	6 months	Measured by change in Modified Roland Morris disability scale (0-23 points)
Change in Bothersomeness of pain	6 months	Measured by change in bothersomeness scale (On a scale of 0-10)

Secondary Outcome Measures

Name	Time	Method
Cost-effectiveness of integrative care for chronic low back pain	12 months	Measured by utilization of health care services and productivity in the workplace

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States