A New Treatment for Chronic Pain Combining Neuromodulation, Computer Assisted Training and Telemonitoring (TechNoPain)

A New Digital Technology-based Treatment for Chronic Pain Combining Neuromodulation, Computerassisted Training and Telemonitoring

Chronic pain (CP) is a leading cause of medical disability, healthcare expenditure, and reduced psychological well-being. Given the limited mobility, travel burden, and cost, access to care can be problematic for patients suffering from this disease, driving the recent shift toward care through telehealth programs. Given the complex interrelationship of physical and psychosocial aspects related to chronic pain, in this project the investigators propose to validate and investigate the effectiveness of new integrated health interventions by combining the technique of transcranial direct current stimulation (tDCS), complementary therapies and telemonitoring. The investigators hypothesize that this novel combined approach will provide a more effective strategy to overcome the classic barriers of pharmacological treatments and access to healthcare due to lack of mobility. To do this, the investigators will rely on a previously developed integrated platform that enables effective delivery of non-pharmacological interventions and outcome assessment. Many patients do not benefit from pharmacological and invasive treatments, leading to the development of alternative therapeutic options such as non-invasive brain stimulation (e.g. tDCS) and complementary interventions to improve physical and psychological well-being. These complementary interventions reduced pain intensity and psychological distress by improving individuals' ability to manage and cope with their pain. However, due to the multiple co-occurring factors associated with chronic pain, a multidisciplinary and integrated treatment approach is challenging. Technology ecosystems can be a reliable tool to achieve such a diverse personalized approach and evaluate their results. In a previous project, the investigators developed PainRE-Life, a dynamic and integrated technology ecosystem to enable continuity of care for CP patients, including personalized applications, training tools and telemonitoring tools for outcome assessment.

Study Overview

• Status: Not yet recruiting
• Conditions: Pain
• Intervention / Treatment: Device: tDCS; Other: EuleriaLab; Combination product: tDCS+EuleriaLab

• Study Type: Interventional
• Enrollment (Estimated): 126
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alberto Priori, PhD; Phone Number: +390250323232; Email: alberto.priori@unimi.it
• Study Contact Backup: Name: Roberta Ferrucci, PhD; Phone Number: +390255033621; Email: roberta.ferrucci@unimi.it

Study Locations

• Italy
  • Milan, Italy
    • Istituto Europeo Di Oncologia
    • Contact: Gabriella Pravettoni, PhD
  • Milan, Italy
    • Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico
    • Contact: Fabiana Ruggiero, PsYD
  • Milan, Italy
    • ASST-Santi Paolo e Carlo Hospital
    • Contact: Alberto Priori, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• patients with chronic pain (Fibromyalgia, Headache, Oncological Pain)
• Age > 18;
• Cognitive and motor skills sufficient to support a rehabilitation process mediated by an electronic device on a signed declaration by the clinician; -Having completed and signed the informed consent form, after a detailed explanation of the task and the tools used in the study.

Exclusion Criteria:

• Have started new pharmacological treatments or have changed therapies that act on pain for less than a month;
• Have a brain stimulator, heart marrow stimulator or pumps for intrathecal drug delivery;
• Respiratory, cardiac, metabolic or other conditions incompatible with at least 30 minutes of light or moderate intensity exercise therapy;
• Aphasia, dementia, or psychiatric comorbidity interfering with communication or rehabilitation program compliance;
• Severe cognitive deficits;
• Blindness or severe vision problems which may interfere with the use of the tablet;
• Presence of cranial bone breaches;
• Recurrent seizures not being treated;
• Insufficient knowledge of the Italian language and/or inability to understand verbal and written instructions;
• Concomitant participation in another study or clinical trial involving rehabilitation therapy (recreational therapy, occupational therapy, physiotherapy) or administration of an investigational drug

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A Group; Only tDCS treatment	Device: tDCS; Non invasive brain stimulation
Active Comparator: B Group; Only Motor Training	Other: EuleriaLab; Home Motor Training
Active Comparator: C Group; Both Treatment (tDCS+Motor Training)	Combination product: tDCS+EuleriaLab; Home based: Non invasive Neuromodulation treatment + Motor Training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale (VAS)	VAS is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (pain) orientated from the left (worst) to the right (best). The patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.	Baseline (Day 1), after 1 week of treatment (Day 5), at the end of the treatment (Day 19), one month follow up (month 1), 3 months follow up (month 3)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
12-item Short Form Survey (SF12)	Short Form Survey (SF-12) is a health-related quality of life assessment tool that measures patients' physical and mental health. The lowest possible value is 0 and the highest is 100. In general, the highest values indicate a better result and the lowest indicate a worse result.	Baseline (Day 1), after 1 week of treatment (Day 5), at the end of the treatment (Day 19), one month follow up (month 1), 3 months follow up (month 3)
Hospital Anxiety and Depression scale (HADS)	The HADS is a self-report rating scale of 14 items on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression (7 items for each subscale). The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0-21). 0-7 (Normal) 8-10 (Mild) 11-15 (Moderate) 16-21 (Severe)	Baseline (Day 1), after 1 week of treatment (Day 5), at the end of the treatment (Day 19), one month follow up (month 1), 3 months follow up (month 3)
Brief Pain Inventory (BPI)	This self-administered questionnaire assesses pain severity and its impact on quality of life through 15 questions. The patients responded using a 10-point Likert scale, with higher scores indicating greater pain severity and greater interference with that aspect of life.	Baseline (Day 1), after 1 week of treatment (Day 5), at the end of the treatment (Day 19), one month follow up (month 1), 3 months follow up (month 3)
Pain Catastrophizing Scale (PCS)	This self-administered questionnaire measures catastrophic thinking related to chronic pain. The patients rated how often they have 13 different thoughts and feelings while experiencing pain from 0 to 4. The total sum of the scores ranges between 0 and 52, with higher total scores indicating more catastrophic thinking.	Baseline (Day 1), after 1 week of treatment (Day 5), at the end of the treatment (Day 19), one month follow up (month 1), 3 months follow up (month 3)
Shared Decision-Making Questionnaire 9-Item (SDM-Q-9)	The SDM-Q-9 instrument was developed to assess the patient subjective experience of SDM according to nine stages on the decision-making process. It describes the experience of SDM through nine items which are scored on a six-point Likert scale from 0 (completely disagree) to 5 (completely agree).	Baseline (Day 1), after 1 week of treatment (Day 5), at the end of the treatment (Day 19), one month follow up (month 1), 3 months follow up (month 3)

Collaborators and Investigators

• Sponsor: ASST Santi Paolo e Carlo
• Collaborators: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico; University of Milan; Istituto Europeo di Oncologia
• Investigators: Principal Investigator: Alberto Priori, PhD, ASST-Santi Paolo e Carlo Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): January 31, 2026
• Study Completion (Estimated): April 30, 2026

Study Registration Dates

• First Submitted: March 4, 2024
• First Submitted That Met QC Criteria: March 8, 2024
• First Posted (Actual): March 12, 2024

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 8, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: tDCS; pain; neuromodulation; telemonitoring; motor training
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: 2022/ST/217

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: all IPD that underlie results in a publication
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No