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Clinical Trials/NCT04168437
NCT04168437
Completed
Not Applicable

Optimizing Chronic Pain Management Through Patient Engagement With Quality of Life Measures: A Randomized Controlled Trial

University of North Texas Health Science Center1 site in 1 country331 target enrollmentNovember 26, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Low Back Pain
Sponsor
University of North Texas Health Science Center
Enrollment
331
Locations
1
Primary Endpoint
PROMIS-29 Quality of Life Measures
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 26, 2019
End Date
October 31, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

John C. Licciardone, D.O., M.S., M.B.A.

Principal Investigator

University of North Texas Health Science Center

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

Outcomes

Primary Outcomes

PROMIS-29 Quality of Life Measures

Time Frame: 3 Months Post-Randomization

SPADE Cluster Scores (population mean, 50)

Secondary Outcomes

  • Low Back Pain Intensity(3 Months Post-Randomization)
  • Back-Related Disability(3 Months Post-Randomization)

Study Sites (1)

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