Optimizing Chronic Pain Management Through Patient Engagement With Quality of Life Measures (OPTIQUAL)
Primary Purpose
Chronic Low Back Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Health-Related Quality of Life Report
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Low Back Pain focused on measuring Back Pain, Quality of Life, PROMIS-29, PRECISION Pain Research Registry
Eligibility Criteria
Inclusion Criteria:
- Chronic Low Back Pain AND SPADE Cluster Score ≥ 55
Exclusion Criteria:
- Absence of Chronic Low Back Pain OR SPADE Cluster Score < 55
Sites / Locations
- University of North Texas Health Science Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Health-Related Quality of Life Report
Wait List to Receive the Report
Arm Description
Participants randomized to this arm will receive the 2- page Health-Related Quality of Life Report.
Participants randomized to this arm will receive the 2- page Health-Related Quality of Life Report following completion of the study.
Outcomes
Primary Outcome Measures
PROMIS-29 Quality of Life Measures
SPADE Cluster Scores (population mean, 50)
Secondary Outcome Measures
Low Back Pain Intensity
Numerical Rating Scale for Pain (0-10)
Back-Related Disability
Roland-Morris Disability Questionnaire (0-24)
Full Information
NCT ID
NCT04168437
First Posted
November 15, 2019
Last Updated
May 18, 2022
Sponsor
University of North Texas Health Science Center
1. Study Identification
Unique Protocol Identification Number
NCT04168437
Brief Title
Optimizing Chronic Pain Management Through Patient Engagement With Quality of Life Measures
Acronym
OPTIQUAL
Official Title
Optimizing Chronic Pain Management Through Patient Engagement With Quality of Life Measures: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
November 26, 2019 (Actual)
Primary Completion Date
August 31, 2021 (Actual)
Study Completion Date
October 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of North Texas Health Science Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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 primarily 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. Another aspect of the study will be to determine how the health-related quality of life report may impact the physician-patient interaction. This will be assessed using validated measures of physician interpersonal manner, empathy, and communication style, as well as end-of-trial survey data acquired from participants assigned to the experimental group. The survey will include an overall assessment of the report, as well as specific actions attributed to the report.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain
Keywords
Back Pain, Quality of Life, PROMIS-29, PRECISION Pain Research Registry
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
331 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Health-Related Quality of Life Report
Arm Type
Experimental
Arm Description
Participants randomized to this arm will receive the 2- page Health-Related Quality of Life Report.
Arm Title
Wait List to Receive the Report
Arm Type
No Intervention
Arm Description
Participants randomized to this arm will receive the 2- page Health-Related Quality of Life Report following completion of the study.
Intervention Type
Other
Intervention Name(s)
Health-Related Quality of Life Report
Intervention Description
Two page report and interpretation guide based on SPADE cluster scores
Primary Outcome Measure Information:
Title
PROMIS-29 Quality of Life Measures
Description
SPADE Cluster Scores (population mean, 50)
Time Frame
3 Months Post-Randomization
Secondary Outcome Measure Information:
Title
Low Back Pain Intensity
Description
Numerical Rating Scale for Pain (0-10)
Time Frame
3 Months Post-Randomization
Title
Back-Related Disability
Description
Roland-Morris Disability Questionnaire (0-24)
Time Frame
3 Months Post-Randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Chronic Low Back Pain AND SPADE Cluster Score ≥ 55
Exclusion Criteria:
Absence of Chronic Low Back Pain OR SPADE Cluster Score < 55
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John C Licciardone, DO, MS, MBA
Organizational Affiliation
University of North Texas Health Science Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Texas Health Science Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76107
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Optimizing Chronic Pain Management Through Patient Engagement With Quality of Life Measures
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