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Completed

NCT Number: NCT01355237

Observational Cohort Study of Chronic Low Back Pain

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.

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Key information

Conditions

Back Pain Lower Back Chronic

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Change in functional disability related to low back pain

    Time frame: 6 months

    Measured by change in Modified Roland Morris disability scale (0-23 points)

  2. Change in Bothersomeness of pain

    Time frame: 6 months

    Measured by change in bothersomeness scale (On a scale of 0-10)

Secondary outcomes

  1. Cost-effectiveness of integrative care for chronic low back pain

    Time frame: 12 months

    Measured by utilization of health care services and productivity in the workplace

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • Beth Israel Deaconess Medical Center
  • Harvard Medical School (HMS and HSDM)

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
May 18, 2011
Registry last updated
Jun 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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