Low Back Pain
Conditions
Keywords
low back pain, elderly, back pain, lumbar pain, over 65
Brief summary
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.
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.
Interventions
None listed
Sponsors
Kaiser Permanente
Harvard Vanguard Medical Associates
Henry Ford Health System
Oregon Health and Science University
University of Washington
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Roland- Morris Disability Questionnaire | Baseline, 3, 6 and 12 month timepoints | 24-item back pain specific, functional status questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Brief Pain Inventory | Baseline, 3, 6 and 12 month timepoints | Pain Interference short form |
| Change in Patient Expectation Regarding Recovery | Baseline, 3, 6 and 12 month timepoints | Two questions measuring patient expectations |
| Change in Patient Health Questionnaire-4 (PHQ-4) | Baseline, 3, 6 and 12 month timepoints | Depression and Anxiety Scale |
| Change in Pain Numerical Rating Scale (NRS) | Baseline, 3, 6 and 12 month timepoints | Numerical rating score of pain intensity (0-10 scale) |
| Change in Euro-Qual-D (EQ-5D) | Baseline, 3, 6 and 12 month timepoints | Five item general health-related quality of life measure |
| Change in Falls Assessment | Baseline, 3, 6 and 12 month timepoints | Two questions regarding frequency of falls and any injuries that resulted |
| Electronic Medical Record Data | 12 months before and after index visit for back pain | Imaging, health care utilization, pharmacy, laboratory data extracted from medical records |
| Demographics | Baseline | Demographic information |
Countries
United States
Outcome results
None listed