Low Back PainBOLDNCT01776242
Back Pain Outcomes Using Longitudinal Data (BOLD)
An observational study of Low Back Pain, run by University of Washington at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Low Back Pain
- How many people
- 5,239 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2010to Sep 2013
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Adults over age 65
Who may be able to join
- Age >= 65 years
- Primary care visit for low back pain based on ICD9 code
- No prior visits for low back pain within six months
Who cannot join
- 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
Show all 9Show fewer
- No telephone, or planning to move within a year
- Unable to understand English
- Severe mental impairment that would interfere with answering questions
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Harvard Vanguard Medical Associates
Boston, Massachusetts, 02215
Henry Ford Health System
Detroit, Michigan, 48202
Kaiser-Permanente of Northern California
Oakland, California, 94612
About this study
Official title: Back Pain Outcomes Using Longitudinal Data (BOLD) Registry and Repository
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.
Read the 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.
- Conditions
- Low Back Pain
- Keywords
- low back pain, elderly, back pain, lumbar pain, over 65
- Medical subject headings
- Low Back Pain, Back Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Roland- Morris Disability Questionnaire
24-item back pain specific, functional status questionnaire
Measured: Baseline, 3, 6 and 12 month timepoints
Secondary outcomes (8)
Change in Pain Numerical Rating Scale (NRS)
Numerical rating score of pain intensity (0-10 scale)
Measured: Baseline, 3, 6 and 12 month timepoints
Change in Brief Pain Inventory
Pain Interference short form
Measured: Baseline, 3, 6 and 12 month timepoints
Change in Patient Expectation Regarding Recovery
Two questions measuring patient expectations
Measured: Baseline, 3, 6 and 12 month timepoints
Change in Patient Health Questionnaire-4 (PHQ-4)
Depression and Anxiety Scale
Measured: Baseline, 3, 6 and 12 month timepoints
Demographics
Demographic information
Measured: Baseline
Change in Euro-Qual-D (EQ-5D)
Five item general health-related quality of life measure
Measured: Baseline, 3, 6 and 12 month timepoints
Change in Falls Assessment
Two questions regarding frequency of falls and any injuries that resulted
Measured: Baseline, 3, 6 and 12 month timepoints
Electronic Medical Record Data
Imaging, health care utilization, pharmacy, laboratory data extracted from medical records
Measured: 12 months before and after index visit for back pain
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2013 (estimated)
- Study startSep 2010
- Primary completionMar 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,239 participants (actual)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Kaiser Permanente, Harvard Vanguard Medical Associates, Henry Ford Health System, Oregon Health and Science University
- Responsible party
- Principal investigator, Jeffrey G. Jarvik, MD, MPH, University of Washington
- Investigators
- Jeffrey Jarvik, MD, MPH, Principal investigator, University of WashingtonRick Deyo, MD, MPH, Principal investigator, Oregon Health and Science UniversityJanna Friedly, MD, Principal investigator, University of WashingtonPartrick Heagerty, PhD, Principal investigator, University of WashingtonLarry Kessler, ScD, Principal investigator, University of WashingtonSean Sullivan, PhD, Principal investigator, University of WashingtonJudy Turner, PhD, Principal investigator, University of WashingtonAndy Avins, MD, MPH, Principal investigator, Kaiser-Permanente of Northern CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01776242
- Sponsor's protocol ID
- 39009-EA
- Other IDs
- 101H5019222-01
- Acronym
- BOLD
- Status last verified
- Dec 2023
- First submitted
- 13 Jun 2012
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22554166Jarvik 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.
PubMed 24755158
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Back Pain Outcomes Using Longitudinal Data (BOLD) Registry and Repository
- ClinicalTrials.gov ID
- NCT01776242
- Acronym / sponsor ID
- BOLD / 39009-EA
- Conditions
- Low Back Pain
- Keywords
- low back pain, elderly, back pain, lumbar pain, over 65
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,239 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Kaiser Permanente, Harvard Vanguard Medical Associates, Henry Ford Health System, Oregon Health and Science University
- Study start
- Sep 2010
- Primary completion
- Mar 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 28 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Adults over age 65
Key inclusion criteria (3 listed)
- Age >= 65 years
- Primary care visit for low back pain based on ICD9 code
- No prior visits for low back pain within six months
Key exclusion criteria (9 listed)
- Prior lumbar spine surgery
- Developmental spine deformities
- Inflammatory spondyloarthropathy
- Known spinal malignancy or infection
- Primarily nerve compression-related symptoms
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Roland- Morris Disability Questionnaire
Time frame: Baseline, 3, 6 and 12 month timepoints
24-item back pain specific, functional status questionnaire
8 secondary outcomes
Change in Pain Numerical Rating Scale (NRS)
Time frame: Baseline, 3, 6 and 12 month timepoints
Change in Brief Pain Inventory
Time frame: Baseline, 3, 6 and 12 month timepoints
Change in Patient Expectation Regarding Recovery
Time frame: Baseline, 3, 6 and 12 month timepoints
Change in Patient Health Questionnaire-4 (PHQ-4)
Time frame: Baseline, 3, 6 and 12 month timepoints
Demographics
Time frame: Baseline
Change in Euro-Qual-D (EQ-5D)
Time frame: Baseline, 3, 6 and 12 month timepoints
Change in Falls Assessment
Time frame: Baseline, 3, 6 and 12 month timepoints
Electronic Medical Record Data
Time frame: 12 months before and after index visit for back pain
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Background: PubMed 22554166Jarvik 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.
- Derived from this study: PubMed 24755158Jarvik 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.
- Study related informationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey Jarvik, MD, MPH principal investigator
University of Washington
Rick Deyo, MD, MPH principal investigator
Oregon Health and Science University
Janna Friedly, MD principal investigator
University of Washington
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain, run by University of Washington at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Roland- Morris Disability Questionnaire (time frame: Baseline, 3, 6 and 12 month timepoints). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01776242, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2023.