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Completed

NCT Number: NCT01776242

Back Pain Outcomes Using Longitudinal Data (BOLD)

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.

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kaiser-Permanente of Northern California, Oakland, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Change in Roland- Morris Disability Questionnaire

    Time frame: Baseline, 3, 6 and 12 month timepoints

    24-item back pain specific, functional status questionnaire

Secondary outcomes

  1. Change in Pain Numerical Rating Scale (NRS)

    Time frame: Baseline, 3, 6 and 12 month timepoints

    Numerical rating score of pain intensity (0-10 scale)

  2. Change in Brief Pain Inventory

    Time frame: Baseline, 3, 6 and 12 month timepoints

    Pain Interference short form

  3. Change in Patient Expectation Regarding Recovery

    Time frame: Baseline, 3, 6 and 12 month timepoints

    Two questions measuring patient expectations

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

    Time frame: Baseline, 3, 6 and 12 month timepoints

    Depression and Anxiety Scale

  5. Demographics

    Time frame: Baseline

    Demographic information

  6. Change in Euro-Qual-D (EQ-5D)

    Time frame: Baseline, 3, 6 and 12 month timepoints

    Five item general health-related quality of life measure

  7. Change in Falls Assessment

    Time frame: Baseline, 3, 6 and 12 month timepoints

    Two questions regarding frequency of falls and any injuries that resulted

  8. Electronic Medical Record Data

    Time frame: 12 months before and after index visit for back pain

    Imaging, health care utilization, pharmacy, laboratory data extracted from medical records

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • Harvard Vanguard Medical Associates
  • Henry Ford Health System
  • Kaiser Permanente
  • Oregon Health and Science University

Registry information

Official study title

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

Acronym: BOLD

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jan 28, 2013
Registry last updated
Dec 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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