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Back Pain Outcomes Using Longitudinal Data (BOLD)

NCT ID: NCT01776242

Last Updated: 2023-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

5239 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-09-30

Study Completion Date

2013-09-30

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.

Conditions

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Low Back Pain

Keywords

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low back pain elderly back pain lumbar pain over 65

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kaiser Permanente

OTHER

Sponsor Role collaborator

Harvard Vanguard Medical Associates

OTHER

Sponsor Role collaborator

Henry Ford Health System

OTHER

Sponsor Role collaborator

Oregon Health and Science University

OTHER

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Jeffrey G. Jarvik, MD, MPH

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeffrey Jarvik, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Rick Deyo, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Janna Friedly, MD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Partrick Heagerty, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Larry Kessler, ScD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Sean Sullivan, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Judy Turner, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Andy Avins, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Kaiser-Permanente of Northern CA

David Nerenz, PhD

Role: PRINCIPAL_INVESTIGATOR

Henry Ford Health Systems

Srdjan Nedeljkovic, MD

Role: PRINCIPAL_INVESTIGATOR

Harvard-Vanguard Associates

Locations

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Kaiser-Permanente of Northern California

Oakland, California, United States

Site Status

Harvard Vanguard Medical Associates

Boston, Massachusetts, United States

Site Status

Henry Ford Health System

Detroit, Michigan, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 22554166 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24755158 (View on PubMed)

Related Links

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http://www.backpainproject.org

Study related information

Other Identifiers

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101H5019222-01

Identifier Type: OTHER

Identifier Source: secondary_id

39009-EA

Identifier Type: -

Identifier Source: org_study_id