Back Pain Outcomes Using Longitudinal Data (BOLD)
This study is enrolling participants by invitation only.
Sponsor:
University of Washington
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: February 4, 2013
Last verified: February 2013
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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
| Estimated Enrollment: | 5000 |
| Study Start Date: | September 2010 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
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: | February 4, 2013 |
| 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 May 16, 2013