Quality of Life in Managing Chronic Pain

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Chronic Low Back Pain

Intervention / Treatment
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* Other: Health-Related Quality of Life Report


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Health-Related Quality of Life Report<br>Participants randomized to this arm will receive the Health-Related Quality of Life Report. | Other: Health-Related Quality of Life Report<br>* Subject report and interpretation guide based on SPADE cluster scores<br>|
| No Intervention: Wait List to Receive the Report<br>Participants randomized to this arm will receive the Health-Related Quality of Life Report following completion of the study. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Low Back Pain Intensity | Numerical Rating Scale for Pain (0-10). | 3 Months Post-Randomization | 
| Back-Related Disability | Roland-Morris Disability Questionnaire (0-24). | 3 Months Post-Randomization |