Observational Cohort Study of Chronic Low Back Pain

Back Pain Lower Back Chronic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01355237
• Other study ID #: 1R01AT005065-01A1-2
• Secondary ID: 1R01AT005065-01A
• Status: Completed
• Phase: N/A
• First received: May 12, 2011
• Last updated: June 12, 2017
• Start date: February 2012
• Est. completion date: December 2015

Study information

• Verified date: June 2017
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 309
• Est. completion date: December 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Back Pain Lower Back Chronic
• Low Back Pain

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Beth Israel Deaconess Medical Center, Harvard Medical School

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in functional disability related to low back pain	Measured by change in Modified Roland Morris disability scale (0-23 points)	6 months
Primary	Change in Bothersomeness of pain	Measured by change in bothersomeness scale (On a scale of 0-10)	6 months
Secondary	Cost-effectiveness of integrative care for chronic low back pain	Measured by utilization of health care services and productivity in the workplace	12 months