Quality of Life in Managing Chronic Pain

University of North Texas Health Science Center102 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

102

Conditions

Chronic Low Back Pain

Interventions

Subject report and interpretation guide based on SPADE cluster scores

Eligibility

Sex: ALLMin age: 21 YearsMax age: 79 Years

Medical Language ↔ Plain English

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

Locations (1)

University of North Texas Health Science Center

Fort Worth, Texas, United States

Outcomes

Primary Outcomes

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.

Time frame: 3 Months Post-Randomization

Secondary Outcomes

Low Back Pain Intensity

Numerical Rating Scale for Pain (0-10).

Time frame: 3 Months Post-Randomization

Back-Related Disability

Roland-Morris Disability Questionnaire (0-24).

Time frame: 3 Months Post-Randomization

Data from ClinicalTrials.gov

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