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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Health-Related Quality of Life Report | Experimental | Participants randomized to this arm will receive the 2- page Health-Related Quality of Life Report. |
|
| Wait List to Receive the Report | No Intervention | Participants randomized to this arm will receive the 2- page Health-Related Quality of Life Report following completion of the study. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Health-Related Quality of Life Report | Other | Two page report and interpretation guide based on SPADE cluster scores |
|
| Measure | Description | Time Frame |
|---|---|---|
| PROMIS-29 Quality of Life Measures | SPADE Cluster Scores (population mean, 50) | 3 Months Post-Randomization |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John C Licciardone, DO, MS, MBA | University of North Texas Health Science Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Texas Health Science Center | Fort Worth | Texas | 76107 | United States |
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| ID | Term |
|---|---|
| D001416 | Back Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 3 Months Post-Randomization |