Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Other |
Change in healthcare resource utilization- regulated prescriptions filled (after enrollment) |
The change in healthcare resource utilization, measured by counting the number of back-pain related regulated prescriptions filled from the baseline and the past 12 months after enrollment |
Month 12 |
|
Other |
Change in healthcare resource utilization- primary care visits (after enrollment) |
The change in healthcare resource utilization, measured by counting the number of back-pain related primary care visits from the baseline and the past 12 months after enrollment |
Month 12 |
|
Other |
Change in healthcare resource utilization- specialist visits (after enrollment) |
The change in healthcare resource utilization, measured by counting the number of back-pain related specialist visits from the baseline and the past 12 months after enrollment |
Month 12 |
|
Other |
Change in healthcare resource utilization- imaging (after enrollment) |
The change in healthcare resource utilization, measured by counting the number of back-pain related imaging from the baseline and the past 12 months after enrollment |
Month 12 |
|
Other |
Change in healthcare resource utilization- allied health visits (after enrollment) |
The change in healthcare resource utilization, measured by counting the number of back-pain related allied health visits from the baseline and the past 12 months after enrollment |
Month 12 |
|
Other |
Change in healthcare resource utilization- regulated prescriptions filled (before enrollment) |
The change in healthcare resource utilization, measured by counting the number of back-pain related regulated prescriptions filled from the past 12 months before enrollment and baseline. |
12 Month |
|
Other |
Change in healthcare resource utilization- primary care visits (before enrollment) |
The change in healthcare resource utilization, measured by counting the number of back-pain related primary care visits from the past 12 months before enrollment and baseline. |
12 Month |
|
Other |
Change in healthcare resource utilization- specialist visits (before enrollment) |
The change in healthcare resource utilization, measured by counting the number of back-pain related specialist visits from the past 12 months before enrollment and baseline. |
12 Month |
|
Other |
Change in healthcare resource utilization- imaging (before enrollment) |
The change in healthcare resource utilization, measured by counting the number of back-pain related imaging from the past 12 months before enrollment and baseline. |
12 Month |
|
Other |
Change in healthcare resource utilization- allied health visits (before enrollment) |
The change in healthcare resource utilization, measured by counting the number of back-pain related allied health visits from the past 12 months before enrollment and baseline. |
12 Month |
|
Primary |
Change in the pain level |
The change in the pain level between the baseline and 6-week follow-up will be evaluated using the Numeric Pain Rating Scale [0-10]. The 11-point numeric scale ranges from '0' representing "no pain" to '10' representing the "worst pain imaginable". |
Week 6 |
|
Primary |
Change in the pain level |
The change in the pain level between the baseline and 4-month follow-up will be evaluated using the Numeric Pain Rating Scale [0-10]. The 11-point numeric scale ranges from '0' representing "no pain" to '10' representing the "worst pain imaginable". |
Month 4 |
|
Primary |
Change in the pain level |
The change in the pain level between the baseline and 8-month follow-up will be evaluated using the Numeric Pain Rating Scale [0-10]. The 11-point numeric scale ranges from '0' representing "no pain" to '10' representing the "worst pain imaginable". |
Month 8 |
|
Primary |
Change in the pain level |
The change in the pain level between the baseline and 12-month follow-up will be evaluated using the Numeric Pain Rating Scale [0-10]. The 11-point numeric scale ranges from '0' representing "no pain" to '10' representing the "worst pain imaginable". |
Month 12 |
|
Secondary |
Change in the self-reported disability level - Questionnaire A |
The change in the self-reported disability between the baseline and 6-week follow-up will be evaluated using the Oswestry Disability Index [0-100 scale]. |
Week 6 |
|
Secondary |
Change in the self-reported disability level - Questionnaire A |
The change in the self-reported disability between the baseline and 4-month follow-up will be evaluated using the Oswestry Disability Index [0-100 scale]. |
Month 4 |
|
Secondary |
Change in the self-reported disability level - Questionnaire A |
The change in the self-reported disability between the baseline and 8-month follow-up will be evaluated using the Oswestry Disability Index [0-100 scale]. |
Month 8 |
|
Secondary |
Change in the self-reported disability level - Questionnaire A |
The change in the self-reported disability between the baseline and 12-month follow-up will be evaluated using the Oswestry Disability Index [0-100 scale]. |
Month 12 |
|
Secondary |
Change in the self-reported disability level - Questionnaire B |
The change in the self-reported disability between the baseline and 6-week follow-up will be evaluated using the Roland-Morris Low Back Pain and Disability Questionnaire Index [0-24 scale]. |
Week 6 |
|
Secondary |
Change in the self-reported disability level - Questionnaire B |
The change in the self-reported disability between the baseline and 4-month follow-up will be evaluated using the Roland-Morris Low Back Pain and Disability Questionnaire Index [0-24 scale]. |
Month 4 |
|
Secondary |
Change in the self-reported disability level - Questionnaire B |
The change in the self-reported disability between the baseline and 8-month follow-up will be evaluated using the Roland-Morris Low Back Pain and Disability Questionnaire Index [0-24 scale]. |
Month 8 |
|
Secondary |
Change in the self-reported disability level - Questionnaire B |
The change in the self-reported disability between the baseline and 12-month follow-up will be evaluated using the Roland-Morris Low Back Pain and Disability Questionnaire Index [0-24 scale]. |
Month 12 |
|