Clinical trial NCT06306053: A New Treatment for Chronic Pain Combining Neuromodulation, Computer Assisted Training and Telemonitoring
Official title: A New Digital Technology-based Treatment for Chronic Pain Combining Neuromodulation, Computerassisted Training and Telemonitoring
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pain
Keywords: neuromodulation
pain
telemonitoring
motor training
tDCS
Lead sponsor: ASST Santi Paolo e Carlo
Sponsor class: OTHER
Collaborators: name: University of Milan
name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
name: Istituto Europeo di Oncologia
First posted: 2024-03-12
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Visual Analogue Scale (VAS)
timeFrame: 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 outcomes:
measure: 12-item Short Form Survey (SF12)
timeFrame: 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: Hospital Anxiety and Depression scale (HADS)
timeFrame: 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: Brief Pain Inventory (BPI)
timeFrame: 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: Pain Catastrophizing Scale (PCS)
timeFrame: 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: Shared Decision-Making Questionnaire 9-Item (SDM-Q-9)
timeFrame: 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)
Other outcomes:
Locations:
city: Milan
country: Italy
facility: ASST-Santi Paolo e Carlo Hospital
city: Milan
country: Italy
facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
city: Milan
country: Italy
facility: Istituto Europeo di Oncologia
Study officials:
affiliation: ASST-Santi Paolo e Carlo Hospital
name: Alberto Priori, PhD
role: PRINCIPAL_INVESTIGATOR
References: