Quality of Life in Managing Chronic Pain

Chronic Low Back Pain Clinical Trial

Official title:

Health-Related Quality of Life Measures to Optimize Chronic Pain Management

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04060953
• Other study ID #: 300690
• Status: Completed
• Phase: N/A
• Start date: August 16, 2019
• Est. completion date: January 14, 2020

Study information

• Verified date: February 2020
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: January 14, 2020
• Est. primary completion date: January 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• Health-Related Quality of Life Report
Subject 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
Other	Utility of the Health-Related Quality of Life Report	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
Primary	PROMIS-29 Quality of Life Measures	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	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