NCT01776242

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,239

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2010

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

June 13, 2012

Completed
8 months until next milestone

First Posted

Study publicly available on registry

January 28, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

December 5, 2023

Status Verified

December 1, 2023

Enrollment Period

2.5 years

First QC Date

June 13, 2012

Last Update Submit

December 1, 2023

Conditions

Low Back Pain

Keywords

low back painelderlyback painlumbar painover 65

Outcome Measures

Primary Outcomes (1)

  • Change in Roland- Morris Disability Questionnaire

    24-item back pain specific, functional status questionnaire

    Baseline, 3, 6 and 12 month timepoints

Secondary Outcomes (8)

  • Change in Pain Numerical Rating Scale (NRS)

    Baseline, 3, 6 and 12 month timepoints

  • Change in Brief Pain Inventory

    Baseline, 3, 6 and 12 month timepoints

  • Change in Patient Expectation Regarding Recovery

    Baseline, 3, 6 and 12 month timepoints

  • Change in Patient Health Questionnaire-4 (PHQ-4)

    Baseline, 3, 6 and 12 month timepoints

  • Demographics

    Baseline

  • +3 more secondary outcomes

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

Adults over age 65

You may qualify if:

  • Age \>= 65 years
  • Primary care visit for low back pain based on ICD9 code
  • No prior visits for low back pain within six months

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Kaiser-Permanente of Northern California

Oakland, California, 94612, United States

Location

Harvard Vanguard Medical Associates

Boston, Massachusetts, 02215, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Related Publications (2)

  • 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.

    PMID: 22554166BACKGROUND

  • 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.

    PMID: 24755158DERIVED

Related Links

MeSH Terms

Conditions

Low Back PainBack Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jeffrey Jarvik, MD, MPH

    University of Washington

    PRINCIPAL INVESTIGATOR

  • Rick Deyo, MD, MPH

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

  • Janna Friedly, MD

    University of Washington

    PRINCIPAL INVESTIGATOR

  • Partrick Heagerty, PhD

    University of Washington

    PRINCIPAL INVESTIGATOR

  • Larry Kessler, ScD

    University of Washington

    PRINCIPAL INVESTIGATOR

  • Sean Sullivan, PhD

    University of Washington

    PRINCIPAL INVESTIGATOR

  • Judy Turner, PhD

    University of Washington

    PRINCIPAL INVESTIGATOR

  • Andy Avins, MD, MPH

    Kaiser-Permanente of Northern CA

    PRINCIPAL INVESTIGATOR

  • David Nerenz, PhD

    Henry Ford Health Systems

    PRINCIPAL INVESTIGATOR

  • Srdjan Nedeljkovic, MD

    Harvard-Vanguard Associates

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
24 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 13, 2012

First Posted

January 28, 2013

Study Start

September 1, 2010

Primary Completion

March 1, 2013

Study Completion

September 1, 2013

Last Updated

December 5, 2023

Record last verified: 2023-12

Locations

US(3)