Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Other |
Brief Pain Inventory - Short form |
The Brief Pain Inventory (BPI) is considered the secondary outcome variable. The questionnaire assesses pain in two dimensions: pain intensity and pain interference with function, mood, sleep, and social life, and is a recommended core outcome measure in clinical trials of chronic pain. All items are scored from 0-10, with 0 indicating no pain or interference and 10 indicating worst imaginable pain/completely interference. Hence the sum 0-40 is averaged between the four items about pain intensity, and the sum 0-70 is averaged between the seven items about pain interference. |
This PROM is collected at baseline, 3- and 6 months follow up |
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Other |
Insomnia Severity Index |
To assess the patient's sleep quality, the Insomnia Severity Index (ISI) will be utilized. ISI includes seven questions that measure the severity of insomnia experienced over the past two weeks. Respondents assess the severity of difficulties in falling asleep, staying asleep, waking up too early, satisfaction with current sleep, as well as the degree of concern or anxiety caused by sleep problems. Additionally, the impact of sleep difficulties on daytime functioning and whether others notice any impairment related to the sleep issue are also addressed. A 5-point Likert scale (0-4) is used to rate the severity of each area based on the individual's experience. The total score ranges from 0 to 28, where a higher score indicates a greater severity of insomnia. |
This PROM is collected at baseline, 3- and 6 months follow up |
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Other |
Patient Health Questionnaire |
The PHQ-2 assesses the frequency of depressed mood and anhedonia over the past two weeks, resulting in a sum score ranging from 0 to 6 points. A score of 3 points indicates a sensitivity of 82.9% and a specificity of 90.0% for major depressive disorder. |
This PROM is collected at baseline, 3- and 6 months follow up |
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Other |
Generalized Anxiety Disorder |
Symptoms of anxiety were assessed using the Generalized Anxiety Disorder 2 (GAD-2), which comprises the first two questions of the GAD-7. Patients rated their levels of nervousness, anxiety, or worry, along with their ability to control worrying over the past two weeks. Responses were scored from 0 to 3, resulting in a total score ranging from 0 to 6, with higher scores indicating more pronounced symptoms of anxiety. GAD-2 is considered a covariate. |
This PROM is collected at baseline, 3- and 6 months follow up |
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Other |
Work ability score |
The Work Ability Score (WAS) is a single item of the Work Ability Index (WAI), which demonstrates a strong correlation with WAI, revealing similar associations with sick leave, health, and symptoms. In addition, previous research underscores the WAI as a significant prognostic factor for return to work among individuals on long-term sick leave due to pain. In this context, WAS is employed as a predictor for return to work.The scale is scored from 0-10, with higher scores indicating higher self-percieved work ability compared with life time best |
This PROM is collected at baseline, 3- and 6 months follow up |
|
Primary |
Multimorbidity Treatment Burden Questionnaire (MTBQ). |
The MTBQ is a 10-item self-report measure designed to assess the burden experienced by individuals with multiple health conditions. The ten items cover various aspects of treatment burden, such as managing one's own health, including self-monitoring and lifestyle changes, dealing with medication-related challenges (e.g., adherence and obtaining prescriptions), coordinating healthcare appointments, and managing dependency on others. Each item was scored on a scale ranging from 0 to 100. A higher total score on the questionnaire indicates a higher burden. The MTBQ has been shown to possess good content validity, construct validity, reliability, and responsiveness and has a valid version in Danish. |
This PROM is collected at baseline, 3- and 6 month follow up |
|
Secondary |
Health-related quality of life (EQ-5D-5L) |
A measure of health-related quality of life. The EQ-5D-5L assesses health status across five dimensions, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension was rated on a five-point ordinal scale ranging from 1 (indicating no problems) to 5 (indicating extreme difficulties). The questionnaire provides a reliable and valid measure of general health and quality of life and is a valid and responsive quality of life scale for patients with chronic low back pain.The minimal important difference for this outcome varies depending on the condition. |
This PROM is collected at baseline, 3- and 6 months follow up |
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