Observational Cohort Study of Chronic Low Back Pain

NCT01355237 | Completed DMC

• 2 other identifiers: 1R01AT005065-01A1-21R01AT005065-01A1
• Study Type: observational
• Target: 309
• Locations: 1 country
• Sites: 1

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.

Conditions

Back Pain Lower Back Chronic

Keywords

Complementary and alternative medicine (CAM)

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Cost-effectiveness of integrative care for chronic low back pain

  12 months

Study Arms (2)

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

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Harvard Medical School (HMS and HSDM): collaborator
• Beth Israel Deaconess Medical Center: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Study Officials

• Julie E Buring, ScD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 12, 2011
• First Posted: May 18, 2011
• Study Start: February 1, 2012
• Primary Completion: April 1, 2015
• Study Completion: December 1, 2015
• Last Updated: June 14, 2017

Record last verified: 2017-06

Locations

US (1)