Back Pain Outcomes Using Longitudinal Data (BOLD)

Low Back Pain Clinical Trial

— BOLD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01776242
• Other study ID #: 39009-EA
• Secondary ID: 101H5019222-01
• Status: Completed
• Start date: September 2010
• Est. completion date: September 2013

Study information

• Verified date: December 2023
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5239
• Est. completion date: September 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Locations

Country	Name	City	State
United States	Harvard Vanguard Medical Associates	Boston	Massachusetts
United States	Henry Ford Health System	Detroit	Michigan
United States	Kaiser-Permanente of Northern California	Oakland	California

Sponsors (5)

Lead Sponsor	Collaborator
University of Washington	Harvard Vanguard Medical Associates, Henry Ford Health System, Kaiser Permanente, Oregon Health and Science University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Roland- Morris Disability Questionnaire	24-item back pain specific, functional status questionnaire	Baseline, 3, 6 and 12 month timepoints
Secondary	Change in Pain Numerical Rating Scale (NRS)	Numerical rating score of pain intensity (0-10 scale)	Baseline, 3, 6 and 12 month timepoints
Secondary	Change in Brief Pain Inventory	Pain Interference short form	Baseline, 3, 6 and 12 month timepoints
Secondary	Change in Patient Expectation Regarding Recovery	Two questions measuring patient expectations	Baseline, 3, 6 and 12 month timepoints
Secondary	Change in Patient Health Questionnaire-4 (PHQ-4)	Depression and Anxiety Scale	Baseline, 3, 6 and 12 month timepoints
Secondary	Demographics	Demographic information	Baseline
Secondary	Change in Euro-Qual-D (EQ-5D)	Five item general health-related quality of life measure	Baseline, 3, 6 and 12 month timepoints
Secondary	Change in Falls Assessment	Two questions regarding frequency of falls and any injuries that resulted	Baseline, 3, 6 and 12 month timepoints
Secondary	Electronic Medical Record Data	Imaging, health care utilization, pharmacy, laboratory data extracted from medical records	12 months before and after index visit for back pain

External Links

•   Study related information