Quality of Life in Managing Chronic Pain
Health-Related Quality of Life Measures to Optimize Chronic Pain Management
1 other identifier
interventional
102
1 country
1
Brief Summary
This study evaluates the use of a health-related quality of life report based on the SPADE cluster (sleep disturbance, pain interference with activities, anxiety, depression, and low energy/fatigue) derived from the PROMIS-29 instrument in patients with chronic low back pain. Half of the participants will receive the report, while the other half will not.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 16, 2019
CompletedStudy Start
First participant enrolled
August 16, 2019
CompletedFirst Posted
Study publicly available on registry
August 19, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 14, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 14, 2020
CompletedFebruary 26, 2020
February 1, 2020
5 months
August 16, 2019
February 23, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
PROMIS-29 Quality of Life Measures
SPADE Cluster Score (acronym represents Sleep Disturbance, Pain Interference, Anxiety, Depression, and Low Energy/Fatigue subscales derived from the PROMIS-29). Each raw subscale score ranges from 4 to 20. Each subscale raw score is then converted to a population-normed "t-score," with a mean of 50 and standard deviation of 10. The SPADE Cluster Score is then computed as the mean of these five subscale t-scores. Higher t-scores on the SPADE Cluster and each of its component scales represent worse outcomes.
3 Months Post-Randomization
Secondary Outcomes (2)
Low Back Pain Intensity
3 Months Post-Randomization
Back-Related Disability
3 Months Post-Randomization
Other Outcomes (1)
Utility of the Health-Related Quality of Life Report
1 Month Post-Randomization
Study Arms (2)
Health-Related Quality of Life Report
EXPERIMENTALParticipants randomized to this arm will receive the Health-Related Quality of Life Report.
Wait List to Receive the Report
NO INTERVENTIONParticipants randomized to this arm will receive the Health-Related Quality of Life Report following completion of the study.
Interventions
Subject report and interpretation guide based on SPADE cluster scores
Eligibility Criteria
You may qualify if:
- Chronic Low Back Pain based on criteria established by the NIH Task Force on Research Standards for Chronic Low Back Pain AND SPADE Cluster Score ≥ 55
You may not qualify if:
- Absence of Chronic Low Back Pain OR SPADE Cluster Score \< 55
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of North Texas Health Science Center
Fort Worth, Texas, 76107, United States
Study Officials
- PRINCIPAL INVESTIGATOR
John C Licciardone, DO
University of North Texas Health Science Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 16, 2019
First Posted
August 19, 2019
Study Start
August 16, 2019
Primary Completion
January 14, 2020
Study Completion
January 14, 2020
Last Updated
February 26, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share