Optimizing Chronic Pain Management Through Patient Engagement With Quality of Life Measures

Chronic Low Back Pain Clinical Trial

— OPTIQUAL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04168437
• Other study ID #: 2015-169
• Status: Completed
• Phase: N/A
• Start date: November 26, 2019
• Est. completion date: October 31, 2021

Study information

• Verified date: May 2022
• Source: University of North Texas Health Science Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 331
• Est. completion date: October 31, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 79 Years

Eligibility

Inclusion Criteria:

• Chronic Low Back Pain AND SPADE Cluster Score = 55

Exclusion Criteria:

• Absence of Chronic Low Back Pain OR SPADE Cluster Score < 55

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Chronic Pain
• Low Back Pain

Intervention

Other:
• Health-Related Quality of Life Report
Two page report and interpretation guide based on SPADE cluster scores

Locations

Country	Name	City	State
United States	University of North Texas Health Science Center	Fort Worth	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of North Texas Health Science Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PROMIS-29 Quality of Life Measures	SPADE Cluster Scores (population mean, 50)	3 Months Post-Randomization
Secondary	Low Back Pain Intensity	Numerical Rating Scale for Pain (0-10)	3 Months Post-Randomization
Secondary	Back-Related Disability	Roland-Morris Disability Questionnaire (0-24)	3 Months Post-Randomization