Pain in Neurorehabilitation Through Wearable Devices: an Exploratory Study — PAINLESS  

Pain Clinical Trial

Official title: Pain Assessment in Neurorehabilitation Through Physiological Signals Recorded by Wearable Devices in Real-world Context: an Exploratory Study

Status Recruiting

Clinical Trial Summary

This exploratory interventional study aims at exploring the feasibility of using physiological signals recorded through wearable devices, together with artificial intelligence techniques, to assess pain automatically and objectively. Automatic methods to assess presence/absence of pain, discern nociceptive from neuropathic pain, and estimate the intensity of pain will be trained an tested on a population of multiple sclerosis patients undergoing neurorehabilitation.

Clinical Trial Description

In patients with Multiple Sclerosis (MS), pain is one of the most common symptoms. The pain described by MS patients is often diffuse, chronic, and debilitating, generally associated with psychological distress and decreased daily functioning.

The presence of pain adversely affects the neurorehabilitation process itself. Patients with pain may refuse to participate in therapy sessions or request to terminate early. However, the link between the frequency and/or intensity of pain and the rehabilitation process is largely unexplored. This is also exacerbated by the different sources of pain experienced by MS patients who require neurorehabilitative interventions.

In clinical practice, pain assessment is conducted mainly using self-administered questionnaires or scales. These tools however can be influenced by many factors, including emotional or cognitive aspects and cannot give an objective measure of the pain experience.

To date, there are no objective and simple-to-use clinical methods that allow objective quantification of the painful experience and a diagnostic differentiation between the two main types of pain, which are nociceptive pain (arising from nociceptive stimuli), and neuropathic pain (caused by a lesion or a pathology of the somatosensory nervous system). In this sense, wearable technologies which can continuously monitor physiological parameters related to pain can be used for the quantification of physiological measures related to pain experience.

AIMS: This study aims at exploring the feasibility of developing methods based on wearable sensors and artificial intelligence algorithms to assess pain objectively and automatically in patients undergoing neurorehabilitation. The specific objectives of this study are the following:

• To assess the feasibility of developing a differential diagnosis method to evaluate the absence or presence of pain

• To assess the feasibility of developing a regression model to evaluate the intensity of pain

• To assess the feasibility of developing a differential diagnosis method to discern the type of pain (i.e., nociceptive vs. neuropathic pain) ;

Related Conditions & MeSH terms

• Multiple Sclerosis
• Pain

• NCT number: NCT05747040
• Study type: Interventional
• Source: Azienda Usl di Bologna
• Contact: Fabio La Porta
• Phone: 0516225851
• Email: fabio.laporta@isnb.it
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2023
• Completion date: October 1, 2023