Clinical trial NCT01776242: Back Pain Outcomes Using Longitudinal Data (BOLD)
Official title: Back Pain Outcomes Using Longitudinal Data (BOLD) Registry and Repository
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low Back Pain
Keywords: low back pain
elderly
back pain
lumbar pain
over 65
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Kaiser Permanente
name: Harvard Vanguard Medical Associates
name: Henry Ford Health System
name: Oregon Health and Science University
First posted: 2013-01-28
Enrollment: 5239
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults over age 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.

Eligibility 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

Primary outcomes:
measure: Change in Roland- Morris Disability Questionnaire
timeFrame: Baseline, 3, 6 and 12 month timepoints
Secondary outcomes:
measure: Change in Pain Numerical Rating Scale (NRS)
timeFrame: Baseline, 3, 6 and 12 month timepoints
measure: Change in Brief Pain Inventory
timeFrame: Baseline, 3, 6 and 12 month timepoints
measure: Change in Patient Expectation Regarding Recovery
timeFrame: Baseline, 3, 6 and 12 month timepoints
measure: Change in Patient Health Questionnaire-4 (PHQ-4)
timeFrame: Baseline, 3, 6 and 12 month timepoints
measure: Demographics
timeFrame: Baseline
measure: Change in Euro-Qual-D (EQ-5D)
timeFrame: Baseline, 3, 6 and 12 month timepoints
measure: Change in Falls Assessment
timeFrame: Baseline, 3, 6 and 12 month timepoints
measure: Electronic Medical Record Data
timeFrame: 12 months before and after index visit for back pain
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Kaiser-Permanente of Northern California
state: California
city: Boston
country: United States
facility: Harvard Vanguard Medical Associates
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
Study officials:
affiliation: University of Washington
name: Jeffrey Jarvik, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Oregon Health and Science University
name: Rick Deyo, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: Janna Friedly, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: Partrick Heagerty, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: Larry Kessler, ScD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: Sean Sullivan, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: Judy Turner, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kaiser-Permanente of Northern CA
name: Andy Avins, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Henry Ford Health Systems
name: David Nerenz, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Harvard-Vanguard Associates
name: Srdjan Nedeljkovic, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jarvik JG, Comstock BA, Bresnahan BW, Nedeljkovic SS, Nerenz DR, Bauer Z, Avins AL, James K, Turner JA, Heagerty P, Kessler L, Friedly JL, Sullivan SD, Deyo RA. Study protocol: the Back Pain Outcomes using Longitudinal Data (BOLD) registry. BMC Musculoskelet Disord. 2012 May 3;13:64. doi: 10.1186/1471-2474-13-64.
citation: Jarvik JG, Comstock BA, Heagerty PJ, Turner JA, Sullivan SD, Shi X, Nerenz DR, Nedeljkovic SS, Kessler L, James K, Friedly JL, Bresnahan BW, Bauer Z, Avins AL, Deyo RA. Back pain in seniors: the Back pain Outcomes using Longitudinal Data (BOLD) cohort baseline data. BMC Musculoskelet Disord. 2014 Apr 23;15:134. doi: 10.1186/1471-2474-15-134.