PainPAINLESSNCT05747040
Pain in Neurorehabilitation Through Wearable Devices: an Exploratory Study
A study testing monitoring in people with Pain and Multiple Sclerosis, run by Azienda Usl di Bologna at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pain, Multiple Sclerosis
- What is being tested?
- monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2023to 1 Oct 2023
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 75 years
- Diagnosis of Multiple Sclerosis for at least three months post-onset
- Prescription of a physiotherapy-based motor rehabilitation program
- Signature of the informed consent to participate in the study
Who cannot join
- Heart rhythm modifying disease and/or factors such as arrhythmogenic heart disease (e.g., atrial fibrillation), presence of pacemakers and/or use of drugs capable of affecting heart rhythm, such as beta blockers (C07) or other antiarrhythmic drugs (C01)
- Cognitive impairments that preclude the possibility of providing valid informed consent, such as a disorder of consciousness or confusional state, the latter defined by temporal and/or spatial disorientation detected during ordinary conversation. In case of doubt, a simple confusional state assessment test (4AT) will be administered before enrollment
- Language comprehension skills lower than 75% in an ordinary conversation due to aphasic disorder of severe deafness despite the use of a hearing aid. In case of doubt, a simple language comprehension test (token test) will be administered before enrollment
- Linguistic expression less than 75%. In case of doubt, a simple verbal fluency test (verbal fluency by phonemic category) will be administered before enrollment
- Severe psychiatric comorbidity that may interfere with adherence to the study protocol (e.g., severe personality disorders, severe psychomotor agitation)
- History or current use of narcotic drugs (including marijuana)
- Modification in the two weeks prior to enrollment or foreseeable modification during enrollment of any chronic pain management program, both pharmacological (cortisone for systemic use, H02; antirheumatics, M01; analgesics, N02; antiepileptics, N03; antidepressants tricyclics, N06AA; atypical antidepressants such as duloxetine or venlafaxine, N06AX) and non-pharmacological (e.g., acupuncture or other manual therapies, physical therapies, such as tecar therapy)
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Irccs - Istituto Delle Scienze Neurologiche
Bologna, 40139
Fabio La Porta, Md, 051 622 5111, fabiolaporta@mail.com
Fabio La Porta, 051 622 5111, fabiolaporta@mail.com
About this study
Official title: Pain Assessment in Neurorehabilitation Through Physiological Signals Recorded by Wearable Devices in Real-world Context: an Exploratory Study
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.
Read the detailed 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)
- Conditions
- Pain, Multiple Sclerosis
- Being tested
- monitoring
- Keywords
- Pain assessment, physiological signals, wearable sensors, artificial intelligence, machine learning
- Medical subject headings
- Pain, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
monitoringDiagnostic test
The intervention consists of 48-h monitoring by using two types of monitoring: an objective monitoring, through a class IIa wearable medical device recording four physiological signals, and a subjective monitoring through a questionnaire developed with Microsoft Forms that can be compiled with a smartphone. The monitoring will be conducted during a motor neurorehabilitation treatment, 24 hours before and 24 hours after the treatment at the participant's home. Besides this monitoring, stratification questionnaires will be administered to each participant to be stratified in one of the three categories (absence of pain, nociceptive pain, or neuropathic pain) based on the following timeline:
t0: baseline t1: pre-treatment t2: post-treatment t3: follow-up
| Study group | Role | What they receive |
|---|---|---|
| 48-h monitoring | Other | The intervention consists of 48-h monitoring by using two types of monitoring: an objective monitoring, through a class IIa wearable medical device recording four physiological signals, and a subjective monitoring through a questionnaire developed with Microsoft Forms that can be compiled with a smartphone. The monitoring will be conducted during a motor neurorehabilitation treatment, 24 hours before and 24 hours after the treatment at the participant's home. Besides this monitoring, stratification questionnaires will be administered to each participant to be stratified in one of the three categories (absence of pain, nociceptive pain, or neuropathic pain) based on the following timeline:
* t0: baseline
* t1: pre-treatment
* t2: post-treatment
* t3: follow-up Receives: Diagnostic Test: monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of registrations
Number of concurrent physiological signal registrations and pain assessments through CRF monitoring questionnaire and CRF monitoring questionnaire-intervention. Diagnostic performance of the classifier (i.e., sensitivity, specificity, predictive value) against the gold standard (outcomes from CRF monitoring questionnaire and CRF monitoring questionnaire-intervention).
Measured: The monitoring will be conducted during the intervention time frame [48 hours]
Secondary outcomes (1)
regression model - intensity of pain
Number of concurrent physiological signal registrations and pain assessments through CRF monitoring questionnaire and CRF monitoring questionnaire-intervention. Coefficient of determination of the regression model against the gold standard (outcomes from CRF monitoring questionnaires and CRF monitoring questionnaires-intervention).
Measured: 24 hours before and 24 hours after the treatment at the participant's home
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study start1 Feb 2023
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Usl di Bologna
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05747040
- Sponsor's protocol ID
- 001.2022.ISNB.NeuroRehab.MR-NR
- Acronym
- PAINLESS
- Status last verified
- Feb 2023
- First submitted
- 2 Jan 2023
- Last updated
- 28 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Moscato S, Orlandi S, Di Gregorio F, Lullini G, Pozzi S, Sabattini L, Chiari L, La Porta F. Feasibility interventional study investigating PAIN in neurorehabilitation through wearabLE SensorS (PAINLESS): a study protocol. BMJ Open. 2023 Nov 22;13(11):e073534. doi: 10.1136/bmjopen-2023-073534.
PubMed 37993169
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Assessment in Neurorehabilitation Through Physiological Signals Recorded by Wearable Devices in Real-world Context: an Exploratory Study
- ClinicalTrials.gov ID
- NCT05747040
- Acronym / sponsor ID
- PAINLESS / 001.2022.ISNB.NeuroRehab.MR-NR
- Conditions
- Pain, Multiple Sclerosis
- Keywords
- Pain assessment, physiological signals, wearable sensors, artificial intelligence, machine learning
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Azienda Usl di BolognaOther government
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 28 Feb 2023 (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.
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.
Detailed 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)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 48-h monitoring | Other | Diagnostic Test: monitoringThe intervention consists of 48-h monitoring by using two types of monitoring: an objective monitoring, through a class IIa wearable medical device recording four physiological signals, and a subjective monitoring through a questionnaire developed with Microsoft Forms that can be compiled with a smartphone. The monitoring will be conducted during a motor neurorehabilitation treatment, 24 hours before and 24 hours after the treatment at the participant's home. Besides this monitoring, stratification questionnaires will be administered to each participant to be stratified in one of the three categories (absence of pain, nociceptive pain, or neuropathic pain) based on the following timeline: * t0: baseline * t1: pre-treatment * t2: post-treatment * t3: follow-up |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 18 and 75 years
- Diagnosis of Multiple Sclerosis for at least three months post-onset
- Prescription of a physiotherapy-based motor rehabilitation program
- Signature of the informed consent to participate in the study
Key exclusion criteria (7 listed)
- Heart rhythm modifying disease and/or factors such as arrhythmogenic heart disease (e.g., atrial fibrillation), presence of pacemakers and/or use of drugs capable of affecting heart rhythm, such as beta blockers (C07) or other antiarrhythmic drugs (C01)
- Cognitive impairments that preclude the possibility of providing valid informed consent, such as a disorder of consciousness or confusional state, the latter defined by temporal and/or spatial disorientation detected during ordinary conversation. In case of doubt, a simple confusional state assessment test (4AT) will be administered before enrollment
- Language comprehension skills lower than 75% in an ordinary conversation due to aphasic disorder of severe deafness despite the use of a hearing aid. In case of doubt, a simple language comprehension test (token test) will be administered before enrollment
- Linguistic expression less than 75%. In case of doubt, a simple verbal fluency test (verbal fluency by phonemic category) will be administered before enrollment
- Severe psychiatric comorbidity that may interfere with adherence to the study protocol (e.g., severe personality disorders, severe psychomotor agitation)
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 |
|---|---|---|
| monitoringThe intervention consists of 48-h monitoring by using two types of monitoring: an objective monitoring, through a class IIa wearable medical device recording four physiological signals, and a subjective monitoring through a questionnaire developed with Microsoft Forms that can be compiled with a smartphone. The monitoring will be conducted during a motor neurorehabilitation treatment, 24 hours before and 24 hours after the treatment at the participant's home. Besides this monitoring, stratification questionnaires will be administered to each participant to be stratified in one of the three categories (absence of pain, nociceptive pain, or neuropathic pain) based on the following timeline: t0: baseline t1: pre-treatment t2: post-treatment t3: follow-up | Diagnostic test | 48-h monitoring |
Primary outcome
Number of registrations
Time frame: The monitoring will be conducted during the intervention time frame [48 hours]
Number of concurrent physiological signal registrations and pain assessments through CRF monitoring questionnaire and CRF monitoring questionnaire-intervention. Diagnostic performance of the classifier (i.e., sensitivity, specificity, predictive value) against the gold standard (outcomes from CRF monitoring questionnaire and CRF monitoring questionnaire-intervention).
1 secondary outcome
regression model - intensity of pain
Time frame: 24 hours before and 24 hours after the treatment at the participant's home
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2023.
- Derived from this study: PubMed 37993169Moscato S, Orlandi S, Di Gregorio F, Lullini G, Pozzi S, Sabattini L, Chiari L, La Porta F. Feasibility interventional study investigating PAIN in neurorehabilitation through wearabLE SensorS (PAINLESS): a study protocol. BMJ Open. 2023 Nov 22;13(11):e073534. doi: 10.1136/bmjopen-2023-073534.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing monitoring in people with Pain and Multiple Sclerosis, run by Azienda Usl di Bologna at 1 site 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 4 inclusion and 7 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 28 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Fabio La Porta (0516225851, fabio.laporta@isnb.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of registrations (time frame: The monitoring will be conducted during the intervention time frame [48 hours]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05747040, which also lists 1 linked publication.
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 28 Feb 2023.