Back Pain Outcomes Using Longitudinal Data (BOLD)

Completed

• Conditions: Low Back Pain

• Registration Number: NCT01776242
• Lead Sponsor: University of Washington

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.

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2012-06-13
• Study First Submitted QC: 2013-01-22
• Study First Posted: 2013-01-28
• Primary Completion: 2013-03
• Study Completion: 2013-09
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-01
• Last Update Posted: 2023-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5239

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Roland- Morris Disability Questionnaire	Baseline, 3, 6 and 12 month timepoints	24-item back pain specific, functional status questionnaire

Secondary Outcome Measures

Name	Time	Method
Change in Brief Pain Inventory	Baseline, 3, 6 and 12 month timepoints	Pain Interference short form
Demographics	Baseline	Demographic information
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 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 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
Change in Euro-Qual-D (EQ-5D)	Baseline, 3, 6 and 12 month timepoints	Five item general health-related quality of life measure

Trial Locations

Locations (3)

Harvard Vanguard Medical Associates; 🇺🇸 Boston, Massachusetts, United States

Kaiser-Permanente of Northern California; 🇺🇸 Oakland, California, United States

Henry Ford Health System; 🇺🇸 Detroit, Michigan, United States