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Completed

NCT Number: NCT04060953

Quality of Life in Managing Chronic Pain

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

Conditions

Chronic Low Back Pain

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 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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Health-Related Quality of Life Report

Other

Subject 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 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 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).

Other outcomes

  1. Utility of the Health-Related Quality of Life Report

    Time frame: 1 Month Post-Randomization

    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.

Sponsors and collaborators

Lead sponsor

University of North Texas Health Science Center

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 19, 2019
Registry last updated
Feb 26, 2020

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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