No intervention
OtherObservational study with no intervention - Monitoring
NCT Number: NCT06044584
The pAIn-sense study aims to revolutionize the monitoring and treatment of chronic pain, a major health concern that significantly impacts psychological well-being and quality of life. Traditional approaches to pain management face challenges like unspecific drug use and high healthcare costs, and they often leave patients dissatisfied. PAIn-sense aims at comprehensively understanding pain from both physical and emotional perspectives. To accomplish this, the study will employ advanced Artificial Intelligence (AI) techniques and wearable sensing technology. The study aims to monitor patients continuously, during both day and night activities, to gather a multidimensional set of data on their physiological, psychosocial, and pain conditions.
Interested in participating?
Request Info18 year–80 year
All sexes
Observational
Unita Spinale ASL, Pietra Ligure, Savona, Italy
Chronic pain has long been known as one of the major health concerns, impacting psychological health, functioning, and quality of life. However, its treatment is complex and is challenged by a complex interplay between biological, psychological, and social factors. Common pain treatments present significant medical and technological limitations, reflected in unspecific drug usage and an extremely high number of medical examinations that patients face regularly, with a huge cost burden on the healthcare system. Furthermore, the overall efficacy of pain management is often limited (73% dissatisfaction with treatment), leaving the patient in poor life conditions. Designing individualized targeted therapies requires understanding each subject's multidimensional pain experience, taking into consideration both the physical and emotional aspects involved. However, today, the golden standard measurement for pain is self-reports, which inherently suffer from subjective differences in perception and reporting. Healthcare systems advocate for the discovery of biomarkers and reliable clinical trial endpoints for pain to foster diagnosis, monitor pain progression, assess new treatments, and personalized therapeutic response. Nevertheless, most of the evidence today comes from inpatient settings or controlled laboratory environments. The pAIn-sense study aims at providing a radically novel approach in the monitoring and treatment of pain patients: a novel telemonitoring system allowing to understand the real nature of the pain (emotional vs physical), leveraging the use of advanced Artificial Intelligence techniques and wearable sensing technology collecting biometric data, therefore enabling efficient personalized treatments.
To achieve this goal, the investigators will combine real patient data both from a physical and emotional perspective, to characterize the pain nature of patients and provide a tailored continuum-of-care.
The system will include:
The system will be used to monitor the patient during normal activities (day and night) while collecting physiological, psychosocial, and pain information.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Observational study with no intervention - Monitoring
Time frame: Up to one month
Reported trough a digital health platform by the patients. The level and its dynamic are monitored daily. The pain level is recorded through a score from 1 to 10 that is reported trough a digital health platform by the patients.
Time frame: Up to one month
Monitored using the wearable technology and software digital platforms. Questionnaires will be presented to the patients and will include anxiety, depression, fatigue, pain catastrophizing, sleep, awareness, pain efficacy, treatment expectation
Time frame: Up to one month
Measured and extracted from wearable technology worn continuously. Physiological biomarkers will include Skin Conductance (SC), blood volume pulse (BVP), Heart rate (HR), Brain signals (functional magnetic resonance imaging, electroencephalogram), movements (accelerometer, IMU), temperature.
Time frame: Up to one month
Identified using questionnaires. Scales are usually represented with values from 0 to 10 with 0 best outcome and 10 worst outcome.
Time frame: Up to one month
As described in each patient's constant pain therapy or reported by the patient on request using the platform. Medication will be measure in terms of rate of medications and changes during the protocols, times per day of intake, number of times a on-request medication is taken.
Time frame: Up to one month
Correlation between rehabilitation or physiotherapy attendance and pain
Time frame: Up to one month
Correlation between sleep, activity and other daily factors with pain (measured both from wearable technology and from patients report)
Time frame: Up to one month
Identification and classification of physiological and psychosocial markers, that characterize transition between acute pain and chronic pain
Time frame: Up to one month
QoL index done through questioners and how much pain interfere with the overall quality of life. Scales from 0 to 10, with 10 better outcome and 0 worst outcome.
Time frame: Up to one month
Changes in physiological biomarkers and pain perception following the intake of medication
Contact information is provided by the study sponsor or research team.
ETH Zurich
Other
Unveiling Physiological and Psychosocial Pain Components with an Artificial Intelligence Based Telemonitoring Tool (pAIn-sense)
Acronym: pAIn-sense
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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