PainTechNoPainNCT06306053
A New Treatment for Chronic Pain Combining Neuromodulation, Computer Assisted Training and Telemonitoring
A study testing tDCS+EuleriaLab, tDCS and EuleriaLab in people with Pain, run by ASST Santi Paolo e Carlo at 3 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- tDCS+EuleriaLab, tDCS and EuleriaLab
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 3 sitesItaly
- Study dates
- 1 Apr 2024to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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
Trial locations and contacts
3 sites in 1 country.
Italy3 sites
ASST-Santi Paolo e Carlo Hospital
Milan
Alberto Priori, PhD
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan
Fabiana Ruggiero, PsYD
Istituto Europeo di Oncologia
Milan
Gabriella Pravettoni, PhD
About this study
Official title: 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCS+EuleriaLabCombination product
Home based: Non invasive Neuromodulation treatment + Motor Training
tDCSDevice
Non invasive brain stimulation
EuleriaLabOther
Home Motor Training
| Study group | Role | What they receive |
|---|---|---|
| A Group | Experimental | Only tDCS treatment Receives: Device: tDCS |
| B Group | Active comparator | Only Motor Training Receives: Other: EuleriaLab |
| C Group | Active comparator | Both Treatment (tDCS+Motor Training) Receives: Combination Product: tDCS+EuleriaLab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (5)
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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start1 Apr 2024 (estimated)
- Primary completion31 Jan 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ASST Santi Paolo e Carlo
- Sponsor type
- University, hospital or other
- Collaborators
- University of Milan, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Istituto Europeo di Oncologia
- Responsible party
- Principal investigator, Alberto Priori, ASST Santi Paolo e Carlo
- Investigators
- Alberto Priori, PhD, Principal investigator, ASST-Santi Paolo e Carlo Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06306053
- Sponsor's protocol ID
- 2022/ST/217
- Acronym
- TechNoPain
- Status last verified
- Mar 2024
- First submitted
- 4 Mar 2024
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Digital Technology-based Treatment for Chronic Pain Combining Neuromodulation, Computerassisted Training and Telemonitoring
- ClinicalTrials.gov ID
- NCT06306053
- Acronym / sponsor ID
- TechNoPain / 2022/ST/217
- Conditions
- Pain
- Keywords
- neuromodulation, pain, telemonitoring, motor training, tDCS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- ASST Santi Paolo e CarloUniversity, hospital or other
- Collaborators
- University of Milan, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Istituto Europeo di Oncologia
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 12 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A Group | Experimental | Device: tDCSOnly tDCS treatment |
| B Group | Active comparator | Other: EuleriaLabOnly Motor Training |
| C Group | Active comparator | Combination Product: tDCS+EuleriaLabBoth Treatment (tDCS+Motor Training) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tDCS+EuleriaLabHome based: Non invasive Neuromodulation treatment + Motor Training | Combination product | C Group |
| tDCSNon invasive brain stimulation | Device | A Group |
| EuleriaLabHome Motor Training | Other | B Group |
Primary outcome
Visual Analogue Scale (VAS)
Time frame: 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)
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.
5 secondary outcomes
12-item Short Form Survey (SF12)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alberto Priori, PhD principal investigator
ASST-Santi Paolo e Carlo Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS+EuleriaLab, tDCS and EuleriaLab in people with Pain, run by ASST Santi Paolo e Carlo at 3 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alberto Priori, PhD (+390250323232, alberto.priori@unimi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (VAS) (time frame: 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.