Chronic Low Back Pain
Conditions
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.
Interventions
Subject report and interpretation guide based on SPADE cluster scores
Sponsors
University of North Texas Health Science Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 79 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Utility of the Health-Related Quality of Life Report | 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. |
Countries
United States
Outcome results
None listed