Real-time Treatment of Chronic Pain Using Digital Intelligence
Not yet recruitingNot applicableNCT07454811
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Effectiveness of Digital Intelligence-Supported Real-Time Management in Adults With Chronic Pain: A Randomised Controlled Trial
- Conditions
- Chronic Pain
- Multidisciplinary Biopsychosocial Program
- Quality of Life
- Interventions
- Behavioral: tandard Treatment + Digital Monitoring (Intervention Group)
- Behavioral: Standard Multidisciplinary Treatment (Control Group)
- Sponsor
- Osijek University Hospital
- Start date
- 2026-03-09
- Primary completion
- 2028-03-09
- Sex
- All
- Age range
- from 18 Years to 65 Years
- Results posted
- No results posted in this snapshot
- Countries
- Croatia
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07454811