Real-time Treatment of Chronic Pain Using Digital Intelligence

ain intensity is assessed at baseline, Week 2, and Week 4 using a self-reported 11-point Numeric Rating Scale (0 = no pain; 10 = worst imaginable pain). The outcome represents the change in pain intensity over time, with greater reductions indicating clinical improvement.

Health-related quality of life is assessed using the Croatian-validated Short Form-36 questionnaire. The outcome represents the change in the Physical Functioning domain score (range 0-100; higher scores indicate better functioning) measured at baseline, Week 2, and Week 4. Greater increases in score indicate clinical improvement.

Health-related quality of life is assessed using the Croatian-validated Short Form-36 questionnaire. The outcome represents the change in the Physical Limitations domain score (range 0-100; higher scores indicate fewer physical limitations) measured at baseline, Week 2, and Week 4. Greater increases in score indicate clinical improvement.

Health-related quality of life is assessed using the Croatian-validated Short Form-36 questionnaire. The outcome represents the change in the Emotional Limitations domain score (range 0-100; higher scores indicate fewer emotional limitations) measured at baseline, Week 2, and Week 4. Greater increases in score indicate clinical improvement.

Health-related quality of life is assessed using the Croatian-validated Short Form-36 questionnaire. The outcome represents the change in the Energy and Vitality domain score (range 0-100; higher scores indicate greater energy and vitality) measured at baseline, Week 2, and Week 4. Greater increases in score indicate clinical improvement.

Health-related quality of life is assessed using the Croatian-validated Short Form-36 questionnaire. The outcome represents the change in the Psychological Health domain score (range 0-100; higher scores indicate better psychological well-being) measured at baseline, Week 2, and Week 4. Greater increases in score indicate clinical improvement.

Health-related quality of life is assessed using the Croatian-validated Short Form-36 questionnaire. The outcome represents the change in the Social Functioning domain score (range 0-100; higher scores indicate better social functioning) measured at baseline, Week 2, and Week 4. Greater increases in score indicate clinical improvement.

Health-related quality of life is assessed using the Croatian-validated Short Form-36 questionnaire. The outcome represents the change in the Physical Pain domain score (range 0-100; higher scores indicate less pain) measured at baseline, Week 2, and Week 4. Greater increases in score indicate clinical improvement.

Health-related quality of life is assessed using the Croatian-validated Short Form-36 questionnaire. The outcome represents the change in the General Health domain score (range 0-100; higher scores indicate better perceived health) measured at baseline, Week 2, and Week 4. Greater increases in score indicate clinical improvement.

Disability related to low back pain is assessed using the Croatian-validated version of the Oswestry Disability Index (ODI) 2.1a questionnaire. The outcome represents the change in the total ODI score (range 0-100; higher scores indicate greater disability) measured at baseline, Week 2, and Week 4. Greater decreases in score indicate clinical improvement.

Symptoms of depression are assessed using the Croatian-validated version of the Depression Anxiety Stress Scales-21 (DASS-21). The outcome represents the change in the Depression subscale score measured at baseline, Week 2, and Week 4. Higher scores indicate more severe depressive symptoms, and greater decreases in score indicate clinical improvement.

Symptoms of anxiety are assessed using the Croatian-validated version of the Depression Anxiety Stress Scales-21 (DASS-21). The outcome represents the change in the Anxiety subscale score measured at baseline, Week 2, and Week 4. Higher scores indicate more severe anxiety symptoms, and greater decreases in score indicate clinical improvement.

Stress symptoms are assessed using the Croatian-validated version of the Depression Anxiety Stress Scales-21 (DASS-21). The outcome represents the change in the Stress subscale score measured at baseline, Week 2, and Week 4. Higher scores indicate more severe stress symptoms, and greater decreases in score indicate clinical improvement.

Sleep quality is assessed using the Pittsburgh Sleep Quality Index (PSQI). The outcome represents the change in the Subjective Sleep Quality component score measured at baseline, Week 2, and Week 4. Higher scores indicate worse sleep quality, and greater decreases in score indicate clinical improvement.

Sleep latency is assessed using the Pittsburgh Sleep Quality Index (PSQI). The outcome represents the change in the Sleep Latency component score measured at baseline, Week 2, and Week 4. Higher scores indicate longer time to fall asleep and worse sleep, and greater decreases indicate clinical improvement.

Sleep duration is assessed using the PSQI. The outcome represents the change in the Sleep Duration component score measured at baseline, Week 2, and Week 4. Higher scores indicate shorter sleep duration and worse sleep, and greater decreases indicate clinical improvement.

Habitual Sleep Efficiency is assessed using the PSQI. The outcome represents the change in the Habitual Sleep Efficiency component score measured at baseline, Week 2, and Week 4. Higher scores indicate lower sleep efficiency and worse sleep, and greater decreases indicate clinical improvement.

Sleep Disturbances are assessed using the PSQI. The outcome represents the change in the Sleep Disturbances component score measured at baseline, Week 2, and Week 4. Higher scores indicate more frequent disturbances and worse sleep, and greater decreases indicate clinical improvement.

Use of Sleeping Medication is assessed using the PSQI. The outcome represents the change in the Use of Sleeping Medication component score measured at baseline, Week 2, and Week 4. Higher scores indicate more frequent medication use, and greater decreases indicate clinical improvement.

Daytime Dysfunction is assessed using the PSQI. The outcome represents the change in the Daytime Dysfunction component score measured at baseline, Week 2, and Week 4. Higher scores indicate greater daytime impairment, and greater decreases indicate clinical improvement.

Physical activity (step count) is measured using the Apple Watch wearable device. The outcome represents the average daily step count recorded and summarized for the assessment periods at baseline, Week 2, and Week 4. Higher values indicate greater physical activity.

Sleep quality (Sleep Score) is measured using sleep analysis data generated from sleep stage tracking recorded by the Apple Watch wearable device. The outcome represents the Sleep Score assessed and summarized at baseline, Week 2, and Week 4. Higher scores indicate better sleep quality.

Pain rumination is assessed using the Rumination subscale of the Pain Catastrophizing Scale (PCS), a validated self-report questionnaire measuring repetitive negative focus on pain. The outcome represents the change in the PCS Rumination subscale score measured at baseline, Week 2, and Week 4. Higher scores indicate greater rumination, and greater decreases indicate clinical improvement.

Pain magnification is assessed using the Magnification subscale of the Pain Catastrophizing Scale (PCS). The outcome represents the change in the PCS Magnification subscale score measured at baseline, Week 2, and Week 4. Higher scores indicate greater magnification of pain, and greater decreases indicate clinical improvement.

Pain-related helplessness is assessed using the Helplessness subscale of the Pain Catastrophizing Scale (PCS), a validated self-report questionnaire measuring perceived inability to cope with pain. The outcome represents the change in the PCS Helplessness subscale score measured at baseline, Week 2, and Week 4. Higher scores indicate greater helplessness, and greater decreases indicate clinical improvement.

Pain catastrophizing is assessed using the total score of the Pain Catastrophizing Scale (PCS). The outcome represents the change in the PCS total score measured at baseline, Week 2, and Week 4. Higher scores indicate greater pain catastrophizing, and greater decreases indicate clinical improvement.

Neuropathic pain features are assessed using the painDETECT questionnaire, a validated self-report screening instrument designed to identify neuropathic pain components. The outcome represents the change in the painDETECT total score measured at baseline, Week 2, and Week 4. Higher scores indicate a greater likelihood of neuropathic pain, and greater decreases indicate clinical improvement.

Anxiety symptoms assessed using the Hospital Anxiety and Depression Scale (HADS). The anxiety subscale (HADS-A) consists of 7 items, each scored from 0 to 3, with total scores ranging from 0 to 21. Higher scores indicate greater anxiety symptom severity.

Depressive symptoms assessed using the Hospital Anxiety and Depression Scale (HADS).

The depression subscale (HADS-D) consists of 7 items, each scored from 0 to 3, with total scores ranging from 0 to 21. Higher scores indicate greater depressive symptom severity.

Neck-related disability assessed using the Neck Disability Index (NDI), a 10-item patient- reported questionnaire evaluating the impact of neck pain on daily activities. Each item is

scored from 0 to 5, with total scores ranging from 0 to 50. Higher scores indicate greater neck- related disability.

Beliefs about the personal necessity of prescribed medication assessed using the Beliefs about Medicines Questionnaire (BMQ) at Baseline, Week 2, and Week 4. The BMQ-Specific Necessity subscale consists of 5 items evaluating patients' beliefs about the need for their medication to maintain health and control illness. Each item is rated on a 5-point Likert scale

(1 = strongly disagree to 5 = strongly agree), with total scores ranging from 5 to 25. Higher scores indicate stronger beliefs in the necessity of medication.

Concerns about prescribed medication assessed using the Beliefs about Medicines Questionnaire (BMQ) at Baseline, Week 2, and Week 4. The BMQ-Specific Concerns subscale consists of 5 items evaluating patients' worries about potential adverse effects and long-term consequences of medication. Each item is rated on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree), with total scores ranging from 5 to 25. Higher scores indicate greater concerns about medication.