- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04060953
Quality of Life in Managing Chronic Pain
February 23, 2020 updated by: John C. Licciardone, D.O., M.S., M.B.A., University of North Texas Health Science Center
Health-Related Quality of Life Measures to Optimize Chronic Pain Management
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The health-related quality of life report provides participants with an overall score on the SPADE cluster and scores on each of its five component scales.
The recently released Federal Pain Research Strategy states that pain cannot be measured in isolation, but rather should be assessed in conjunction with other outcome measures in 'non-pain domains,' such as quality of life.
It recognizes that pain may be affected by, and affect, such patient attributes as sleep, mood, cognition, function, and quality of life.
Further, the report states that improvement in pain without concomitant improvement in other domains may not constitute a clinically meaningful outcome.
This study aims to assess the utility of a health-related quality of life report in improving quality of life, back pain intensity, and back-related disability in participants with chronic low back pain.
Study Type
Interventional
Enrollment (Actual)
102
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Fort Worth, Texas, United States, 76107
- University of North Texas Health Science Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 79 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
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
Exclusion Criteria:
Absence of Chronic Low Back Pain OR SPADE Cluster Score < 55
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Health-Related Quality of Life Report
Participants randomized to this arm will receive the Health-Related Quality of Life Report.
|
Subject report and interpretation guide based on SPADE cluster scores
|
No Intervention: Wait List to Receive the Report
Participants randomized to this arm will receive the Health-Related Quality of Life Report following completion of the study.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PROMIS-29 Quality of Life Measures
Time Frame: 3 Months Post-Randomization
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Low Back Pain Intensity
Time Frame: 3 Months Post-Randomization
|
Numerical Rating Scale for Pain (0-10).
|
3 Months Post-Randomization
|
Back-Related Disability
Time Frame: 3 Months Post-Randomization
|
Roland-Morris Disability Questionnaire (0-24).
|
3 Months Post-Randomization
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Utility of the Health-Related Quality of Life Report
Time Frame: 1 Month Post-Randomization
|
Survey of participants in the experimental treatment arm to measure the overall value of the report, various perceptions of it, and actions taken by participants in response to the report, including sharing it with their physicians or other health care providers.
|
1 Month Post-Randomization
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: John C Licciardone, DO, University of North Texas Health Science Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 16, 2019
Primary Completion (Actual)
January 14, 2020
Study Completion (Actual)
January 14, 2020
Study Registration Dates
First Submitted
August 16, 2019
First Submitted That Met QC Criteria
August 16, 2019
First Posted (Actual)
August 19, 2019
Study Record Updates
Last Update Posted (Actual)
February 26, 2020
Last Update Submitted That Met QC Criteria
February 23, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 300690
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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