Clinical trial NCT04168437: Optimizing Chronic Pain Management Through Patient Engagement With Quality of Life Measures
Official title: Optimizing Chronic Pain Management Through Patient Engagement With Quality of Life Measures: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low Back Pain
Keywords: Back Pain
Quality of Life
PROMIS-29
PRECISION Pain Research Registry
Lead sponsor: University of North Texas Health Science Center
Sponsor class: OTHER
First posted: 2019-11-19
Enrollment: 331
Sex: ALL
Minimum age (years): 21
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: PROMIS-29 Quality of Life Measures
timeFrame: 3 Months Post-Randomization
Secondary outcomes:
measure: Low Back Pain Intensity
timeFrame: 3 Months Post-Randomization
measure: Back-Related Disability
timeFrame: 3 Months Post-Randomization
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: University of North Texas Health Science Center
state: Texas
Study officials:
affiliation: University of North Texas Health Science Center
name: John C Licciardone, DO, MS, MBA
role: PRINCIPAL_INVESTIGATOR
References: