Back Pain Outcomes Using Longitudinal Data (BOLD)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Back Pain Outcomes Using Longitudinal Data (BOLD) Registry and Repository

Conditions
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Low Back Pain

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Roland- Morris Disability Questionnaire | 24-item back pain specific, functional status questionnaire | Baseline, 3, 6 and 12 month timepoints | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain Numerical Rating Scale (NRS) | Numerical rating score of pain intensity (0-10 scale) | Baseline, 3, 6 and 12 month timepoints | 
| Change in Brief Pain Inventory | Pain Interference short form | Baseline, 3, 6 and 12 month timepoints | 
| Change in Patient Expectation Regarding Recovery | Two questions measuring patient expectations | Baseline, 3, 6 and 12 month timepoints | 
| Change in Patient Health Questionnaire-4 (PHQ-4) | Depression and Anxiety Scale | Baseline, 3, 6 and 12 month timepoints | 
| Demographics | Demographic information | Baseline | 
| Change in Euro-Qual-D (EQ-5D) | Five item general health-related quality of life measure | Baseline, 3, 6 and 12 month timepoints | 
| Change in Falls Assessment | Two questions regarding frequency of falls and any injuries that resulted | Baseline, 3, 6 and 12 month timepoints | 
| Electronic Medical Record Data | Imaging, health care utilization, pharmacy, laboratory data extracted from medical records | 12 months before and after index visit for back pain | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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low back pain, elderly, back pain, lumbar pain, over 65