Chronic Pain, Multidisciplinary Biopsychosocial Program, Quality of Life
Conditions
Keywords
digital intelligence, real-time pain treatment, chronic pain, pain management
Brief summary
This randomized controlled study will evaluate the effectiveness of real-time digital intelligence in the treatment of chronic pain. A total of 80 adult patients enrolled in a four-week multidisciplinary chronic pain programme will be randomly assigned to either standard treatment alone or standard treatment supported by a smartwatch and a mobile application for real-time monitoring of pain intensity, analgesic use, physical activity, and heart rate. Both groups will complete validated questionnaires assessing pain intensity, disability, quality of life, sleep, anxiety, depression, and treatment satisfaction at baseline, two weeks, and four weeks. The intervention group will additionally record daily pain scores and medication use via a mobile application and wear a smartwatch for continuous activity and heart rate monitoring. The study aims to determine whether real-time digital monitoring and physician availability improve clinical outcomes compared with standard multidisciplinary care alone.
Detailed description
\*\*Detailed Description\*\* This study is a prospective, randomized controlled trial designed to evaluate the added value of real-time digital intelligence in a structured, four-week multidisciplinary chronic pain programme. Eligible adult patients with chronic pain who are enrolled in the programme will be randomly assigned (1:1) to either standard multidisciplinary treatment or standard treatment supplemented with digital monitoring tools. Randomisation will be performed using computer-generated allocation. The control group will receive the usual four-week multidisciplinary intervention and complete validated outcome measures at baseline, week 2, and week 4. These measures will assess pain intensity, pain-related disability, quality of life, sleep quality, anxiety, depression, and treatment satisfaction. The intervention group will receive the same multidisciplinary treatment and assessment schedule. In addition, participants will use a smartwatch to continuously monitor physical activity and heart rate and a mobile application to record daily pain intensity, timing of regular analgesic therapy, and use of rescue medication. Study questionnaires will also be completed through the mobile application. Physicians will have continuous access to patient-reported data during the study period. The primary objective is to determine whether real-time digital monitoring improves clinical outcomes compared with standard multidisciplinary care alone. Secondary objectives include evaluating patient engagement, feasibility of implementation, and satisfaction with digitally supported pain management. Exclusion criteria include refusal to participate and inability to use a smartphone.
Interventions
BEHAVIORALtandard Treatment + Digital Monitoring (Intervention Group)
The intervention group will receive the same multidisciplinary treatment and assessment schedule. Participants will use a smartwatch to continuously monitor physical activity and heart rate
BEHAVIORALStandard Multidisciplinary Treatment (Control Group)
The control group will receive the usual four-week multidisciplinary intervention and complete validated outcome measures at baseline, week 2, and week 4. These measures will assess pain intensity, pain-related disability, quality of life, sleep quality, anxiety, depression, and treatment satisfaction.
Sponsors
Osijek University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-65 years Chronic low back pain significantly affecting disability and/or emotional distress * Active use of Croatian language * Signed informed consent
Exclusion criteria
* Age \<18 or \>65 * Acute pain * Previous participation in multidisciplinary program * Pregnancy or cancer-related pain * Psychotic disorders, moderate-severe cognitive impairment, urgent psychiatric conditions * PTSD symptoms, extreme fatigue, low motivation, low literacy * Allergic reactions to metal or silicone
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain intensity measured at baseline, Week 2, and Week 4 using the Numeric Rating Scale (0-10). | aseline, Week 2, and Week 4 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the SF-36 Physical Functioning domain score from baseline to Week 2 and Week 4. | baseline, Week 2, and Week 4 | 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. |
| Change in the SF-36 Physical Limitations domain score over time, measured at baseline, Week 2, and Week 4. | baseline, Week 2, and Week 4 | 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. |
| Change in the SF-36 Emotional Limitations domain score over time, measured at baseline, Week 2, and Week 4. | baseline, Week 2, and Week 4 | 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. |
| Change in the SF-36 Energy and Vitality domain score over time, measured at baseline, Week 2, and Week 4 | baseline, Week 2, and Week 4 | 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. |
| Change in the SF-36 Psychological Health domain score over time, measured at baseline, Week 2, and Week 4. | baseline, Week 2, and Week 4 | 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. |
| Change in the SF-36 Social Functioning domain score over time, measured at baseline, Week 2, and Week 4 | baseline, Week 2, and Week 4 | 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. |
| Change in the SF-36 Physical Pain domain score over time, measured at baseline, Week 2, and Week 4 | baseline, Week 2, and Week 4 | 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. |
| Change in the SF-36 General Health domain score from baseline to Week 2 and Week 4. | baseline, Week 2, and Week 4 | 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. |
| Change in Oswestry Disability Index (ODI) 2.1a total score from baseline to Week 2 and Week 4 | baseline, Week 2, and Week 4 | 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. |
| Change in Depression score measured by the Depression Anxiety Stress Scales-21 (DASS-21) from baseline to Week 2 and Week 4 | baseline to Week 2 and Week 4 | 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. |
| Change in Anxiety score measured by the Depression Anxiety Stress Scales-21 (DASS-21) from baseline to Week 2 and Week 4 | baseline to Week 2 and Week 4 | 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. |
| Change in Stress score measured by the Depression Anxiety Stress Scales-21 (DASS-21) from baseline to Week 2 and Week 4 | baseline, Week 2, and Week 4 | 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. |
| Change in Subjective Sleep Quality score measured by the Pittsburgh Sleep Quality Index (PSQI) from baseline to Week 2 and Week 4 | baseline to Week 2 and Week 4 | 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. |
| Change in Sleep Latency score measured by the PSQI from baseline to Week 2 and Week 4 | baseline, Week 2, and Week 4. | 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. |
| Change in Sleep Duration score measured by the PSQI from baseline to Week 2 and Week 4 | baseline, Week 2, and Week 4 | 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. |
| Change in Habitual Sleep Efficiency score measured by the PSQI from baseline to Week 2 and Week 4 | baseline, Week 2, and Week 4 | 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. |
| Change in Sleep Disturbances score measured by the PSQI from baseline to Week 2 and Week 4 | baseline, Week 2, and Week 4. | 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. |
| Change in Use of Sleeping Medication score measured by the PSQI from baseline to Week 2 and Week 4 | baseline, Week 2, and Week 4 | 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. |
| Change in Daytime Dysfunction score measured by the PSQI from baseline to Week 2 and Week 4 | baseline to Week 2 and Week 4 | 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) measured by Apple Watch at baseline, Week 2, and Week 4 | baseline, Week 2, and Week 4 | 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) measured by Apple Watch at baseline, Week 2, and Week 4 | baseline, Week 2, and Week 4. | 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. |
| Change in PCS Rumination subscale score from baseline to Week 2 and Week 4 | baseline, Week 2, and Week 4 | 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. |
| Change in PCS Magnification subscale score from baseline to Week 2 and Week 4 | baseline, Week 2, and Week 4 | 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. |
| Change in PCS Helplessness subscale score from baseline to Week 2 and Week 4 | baseline, Week 2, and Week 4 | 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. |
| Change in PCS total score from baseline to Week 2 and Week 4 | baseline, Week 2, and Week 4 | 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. |
| Change in painDETECT questionnaire total score from baseline to Week 2 and Week 4 | baseline, Week 2, and Week 4 | 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. |
| Change in anxiety symptoms measured by the Hospital Anxiety and Depression Scale - Anxiety subscale (HADS-A). | Baseline, Week 2, and Week 4. | 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. |
| Change in depressive symptoms measured by the Hospital Anxiety and Depression Scale - Depression subscale (HADS-D). | Baseline, Week 2, and Week 4. | 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. |
| Change in neck-related disability measured by the Neck Disability Index (NDI). | Baseline, Week 2, and Week 4. | 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 necessity of medication measured by the Beliefs about Medicines Questionnaire - Specific Necessity subscale (BMQ-Specific Necessity) at Baseline, Week 2, and Week 4. | Baseline, Week 2, and Week 4. | 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 medication measured by the Beliefs about Medicines Questionnaire - Specific Concerns subscale (BMQ-Specific Concerns) at Baseline, Week 2, and Week 4. | Baseline, Week 2, and Week 4. | 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. |
Countries
Croatia
Contacts
CONTACTIvan Radoš, assoc.prof
Outcome results
None listed