Quality of Life in Managing Chronic Pain

Not Applicable

Completed

• Conditions: Chronic Low Back Pain
• Interventions: Other: Health-Related Quality of Life Report

• Registration Number: NCT04060953
• Lead Sponsor: University of North Texas Health Science Center

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 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.

Study Timeline

• Study Start: 2019-08-16
• Study First Submitted: 2019-08-16
• Study First Submitted QC: 2019-08-16
• Study First Posted: 2019-08-19
• Primary Completion: 2020-01-14
• Study Completion: 2020-01-14
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-23
• Last Update Posted: 2020-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Health-Related Quality of Life Report	Health-Related Quality of Life Report	Participants randomized to this arm will receive the Health-Related Quality of Life Report.

Primary Outcome Measures

Name	Time	Method
PROMIS-29 Quality of Life Measures	3 Months Post-Randomization	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.

Secondary Outcome Measures

Name	Time	Method
Low Back Pain Intensity	3 Months Post-Randomization	Numerical Rating Scale for Pain (0-10).
Back-Related Disability	3 Months Post-Randomization	Roland-Morris Disability Questionnaire (0-24).

Trial Locations

Locations (1)

University of North Texas Health Science Center; 🇺🇸 Fort Worth, Texas, United States