Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Milan | OTHER |
| Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico | OTHER |
| Istituto Europeo di Oncologia | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A Group | Experimental | Only tDCS treatment |
|
| B Group | Active Comparator | Only Motor Training |
|
| C Group | Active Comparator | Both Treatment (tDCS+Motor Training) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tDCS+EuleriaLab | Combination Product | Home based: Non invasive Neuromodulation treatment + Motor Training |
|
| 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) |
| 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) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alberto Priori, PhD | Contact | +390250323232 | alberto.priori@unimi.it | |
| Roberta Ferrucci, PhD | Contact | +390255033621 | roberta.ferrucci@unimi.it |
| Name | Affiliation | Role |
|---|---|---|
| Alberto Priori, PhD | ASST-Santi Paolo e Carlo Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ASST-Santi Paolo e Carlo Hospital | Milan | Italy |
all IPD that underlie results in a publication
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| tDCS | Device | Non invasive brain stimulation |
|
| EuleriaLab | Other | Home Motor Training |
|
| 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) |
| Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico | Milan | Italy |
|
| Istituto Europeo di Oncologia | Milan | Italy |
|
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |