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Completed

NCT Number: NCT04168437

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

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.

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Key information

Age range

21 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Texas Health Science Center

Fort Worth, Texas, 76107, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Chronic Low Back Pain AND SPADE Cluster Score ≥ 55

Exclusion criteria

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

Treatment and study plan

Health-Related Quality of Life Report

Other

Two page report and interpretation guide based on SPADE cluster scores

Primary outcomes

  1. PROMIS-29 Quality of Life Measures

    Time frame: 3 Months Post-Randomization

    SPADE Cluster Scores (population mean, 50)

Secondary outcomes

  1. Low Back Pain Intensity

    Time frame: 3 Months Post-Randomization

    Numerical Rating Scale for Pain (0-10)

  2. Back-Related Disability

    Time frame: 3 Months Post-Randomization

    Roland-Morris Disability Questionnaire (0-24)

Sponsors and collaborators

Lead sponsor

University of North Texas Health Science Center

Other

Registry information

Official study title

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

Acronym: OPTIQUAL

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Nov 19, 2019
Registry last updated
May 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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