Observational Cohort Study of Chronic Low Back Pain
This study is currently recruiting participants.
Verified February 2013 by Brigham and Women's Hospital
Sponsor:
Brigham and Women's Hospital
Collaborators:
Harvard University
Beth Israel Deaconess Medical Center
Information provided by (Responsible Party):
Julie E. Buring, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01355237
First received: May 12, 2011
Last updated: February 15, 2013
Last verified: February 2013
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Purpose
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 150 Osher Clinical Center (OCC) patients with chronic low back pain (CLBP) compared with a comparison group of 150 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.
| Condition |
|---|
|
Back Pain Lower Back Chronic |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Use and Effectiveness of a Model Integrative Care Clinic in an Academic Hospital: Study II - Observational Cohort Study of Chronic Low Back Pain |
Resource links provided by NLM:
Further study details as provided by Brigham and Women's Hospital:
Primary Outcome Measures:
- Change in functional disability related to low back pain [ Time Frame: 12 months ] [ Designated as safety issue: No ]Measured by change in Modified Roland Morris disability scale (0-23 points)
- Change in Bothersomeness of pain [ Time Frame: 12 months ] [ Designated as safety issue: No ]Measured by change in bothersomeness scale (On a scale of 0-10)
Secondary Outcome Measures:
- Cost-effectiveness of integrative care for chronic low back pain [ Time Frame: 12 months ] [ Designated as safety issue: No ]Measured by utilization of health care services and productivity in the workplace
| Estimated Enrollment: | 300 |
| Study Start Date: | February 2012 |
| Estimated Study Completion Date: | June 2015 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
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| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| 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).
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01355237
Contacts
| Contact: Catherine L Liang, MPH | 617-732-9418 | cliang@partners.org |
Locations
| United States, Massachusetts | |
| Brigham and Women's Hospital | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Julie E Buring, ScD 617-278-0863 jburing@rics.bwh.harvard.edu | |
| Contact: Catherine L Liang, MPH 617-732-9418 cliang@partners.org | |
| Principal Investigator: Julie E Buring, ScD | |
Sponsors and Collaborators
Brigham and Women's Hospital
Harvard University
Beth Israel Deaconess Medical Center
Investigators
| Principal Investigator: | Julie E Buring, ScD | Brigham and Women's Hospital |
More Information
No publications provided
| Responsible Party: | Julie E. Buring, Principal Investigator, Brigham and Women's Hospital |
| ClinicalTrials.gov Identifier: | NCT01355237 History of Changes |
| Other Study ID Numbers: | 1R01AT005065-01A1-2 |
| Study First Received: | May 12, 2011 |
| Last Updated: | February 15, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Brigham and Women's Hospital:
|
Complementary and alternative medicine (CAM) |
Additional relevant MeSH terms:
|
Back Pain Low Back Pain Pain |
Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on June 18, 2013