Back Pain Outcomes Using Longitudinal Data (BOLD)

This study has been completed.
Sponsor:
Collaborators:
Kaiser Permanente
Harvard Vanguard Medical Associates
Henry Ford Health System
Oregon Health and Science University
Information provided by (Responsible Party):
Jeffrey G. Jarvik, MD, MPH, University of Washington
ClinicalTrials.gov Identifier:
NCT01776242
First received: June 13, 2012
Last updated: March 21, 2014
Last verified: March 2014
  Purpose

The overall objective of BOLD is to establish a large, community-based registry (at least 5000 subjects) of patients aged 65 years and older presenting with new episodes of healthcare visits for back pain. BOLD's primary aim is to create an infrastructure that allows for the conduct of prospective, controlled studies comparing the effectiveness of diagnostic and treatment strategies for back pain in older adults.


Condition
Low Back Pain

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 24 Months
Official Title: Back Pain Outcomes Using Longitudinal Data (BOLD) Registry and Repository

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Change in Roland- Morris Disability Questionnaire [ Time Frame: Baseline, 3, 6 and 12 month timepoints ] [ Designated as safety issue: No ]
    24-item back pain specific, functional status questionnaire


Secondary Outcome Measures:
  • Change in Pain Numerical Rating Scale (NRS) [ Time Frame: Baseline, 3, 6 and 12 month timepoints ] [ Designated as safety issue: No ]
    Numerical rating score of pain intensity (0-10 scale)

  • Change in Brief Pain Inventory [ Time Frame: Baseline, 3, 6 and 12 month timepoints ] [ Designated as safety issue: No ]
    Pain Interference short form

  • Change in Patient Expectation Regarding Recovery [ Time Frame: Baseline, 3, 6 and 12 month timepoints ] [ Designated as safety issue: No ]
    Two questions measuring patient expectations

  • Change in Patient Health Questionnaire-4 (PHQ-4) [ Time Frame: Baseline, 3, 6 and 12 month timepoints ] [ Designated as safety issue: No ]
    Depression and Anxiety Scale

  • Demographics [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Demographic information

  • Change in Euro-Qual-D (EQ-5D) [ Time Frame: Baseline, 3, 6 and 12 month timepoints ] [ Designated as safety issue: No ]
    Five item general health-related quality of life measure

  • Change in Falls Assessment [ Time Frame: Baseline, 3, 6 and 12 month timepoints ] [ Designated as safety issue: No ]
    Two questions regarding frequency of falls and any injuries that resulted

  • Electronic Medical Record Data [ Time Frame: 12 months before and after index visit for back pain ] [ Designated as safety issue: No ]
    Imaging, health care utilization, pharmacy, laboratory data extracted from medical records


Enrollment: 5239
Study Start Date: September 2010
Study Completion Date: September 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Detailed Description:

The BOLD registry identifies subjects at the time of a new episode of back pain and captures data in a longitudinal fashion for up to 12 months. The registry captures self-report outcomes data as well as comprehensive utilization data including pharmacy and imaging data through the electronic medical record system. We are applying for additional funding to continue follow-up for up to 4 years from baseline.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Adults over age 65

Criteria

Inclusion Criteria:

  • Age >= 65 years
  • Primary care visit for low back pain based on ICD9 code
  • No prior visits for low back pain within six months

Exclusion Criteria:

  • Prior lumbar spine surgery
  • Developmental spine deformities
  • Inflammatory spondyloarthropathy
  • Known spinal malignancy or infection
  • Primarily nerve compression-related symptoms
  • Serious medical co-morbid condition with life expectancy < 1yr
  • No telephone, or planning to move within a year
  • Unable to understand English
  • Severe mental impairment that would interfere with answering questions
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01776242

Locations
United States, California
Kaiser-Permanente of Northern California
Oakland, California, United States, 94612
United States, Massachusetts
Harvard Vanguard Medical Associates
Boston, Massachusetts, United States, 02215
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202
Sponsors and Collaborators
University of Washington
Kaiser Permanente
Harvard Vanguard Medical Associates
Henry Ford Health System
Oregon Health and Science University
Investigators
Principal Investigator: Jeffrey Jarvik, MD, MPH University of Washington
Principal Investigator: Rick Deyo, MD, MPH Oregon Health and Science University
Principal Investigator: Janna Friedly, MD University of Washington
Principal Investigator: Partrick Heagerty, PhD University of Washington
Principal Investigator: Larry Kessler, ScD University of Washington
Principal Investigator: Sean Sullivan, PhD University of Washington
Principal Investigator: Judy Turner, PhD University of Washington
Principal Investigator: Andy Avins, MD, MPH Kaiser-Permanente of Northern CA
Principal Investigator: David Nerenz, PhD Henry Ford Health Systems
Principal Investigator: Srdjan Nedeljkovic, MD Harvard-Vanguard Associates
  More Information

Additional Information:
Publications:
Responsible Party: Jeffrey G. Jarvik, MD, MPH, Professor, University of Washington
ClinicalTrials.gov Identifier: NCT01776242     History of Changes
Other Study ID Numbers: 39009-EA, 101H5019222-01
Study First Received: June 13, 2012
Last Updated: March 21, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
low back pain
elderly
back pain
lumbar pain
over 65

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014