Real-time Treatment of Chronic Pain Using Digital Intelligence
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorOsijek University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-65 years Chronic low back pain significantly affecting disability and/or emotional distress
Active use of Croatian language
Signed informed consent
Disqualifiers
Age <18 or >65
Acute pain
Previous participation in multidisciplinary program
Pregnancy or cancer-related pain
Trial design
Design model
Parallel
Treatments tested in this trial
tandard Treatment + Digital Monitoring (Intervention Group)
BehavioralThe intervention group will receive the same multidisciplinary treatment and assessment schedule. Participants will use a smartwatch to continuously monitor physical activity and heart rate
Standard Multidisciplinary Treatment (Control Group)
BehavioralThe 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.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Standard Multidisciplinary Treatment + Digital MonitoringExperimental treatment 1 intervention
Group B: Standard Multidisciplinary Treatment (Control Group)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in pain intensity measured at baseline, Week 2, and Week 4 using the Numeric Rating Scale (0-10).
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.
Time frame
aseline, Week 2, and Week 4Secondary outcomes
1
Change in the SF-36 Physical Functioning domain score from baseline to 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.
Time frame
baseline, Week 2, and Week 42
Change in the SF-36 Physical Limitations domain score over time, measured at 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.
Time frame
baseline, Week 2, and Week 43
Change in the SF-36 Emotional Limitations domain score over time, measured at 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.
Time frame
baseline, Week 2, and Week 44
Change in the SF-36 Energy and Vitality domain score over time, measured at 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.
Time frame
baseline, Week 2, and Week 4Sponsors and contacts
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Source ClinicalTrials.gov
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