PainNCT00914173
Pain Monitoring Using Plurality of Non-invasive Physiological Measurement
A study testing Scanlaf Circulator and water bath and Medoc TSA 2000 in people with Pain, run by Medasense Biometrics Ltd at 1 site in Israel.
Trial summary
The clinical trial is intended to implement, validate performances and evaluate efficacy of the pain monitoring device for automated assessment of patient's pain level. The efficacy of the pain monitor will be tested by comparing its results to the patient pain reports towards a given pain stimuli. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Scanlaf Circulator and water bath and Medoc TSA 2000
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2008to Oct 2009
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy participant that response to pain stimuli
- Blood Pressure < (90,140), Heart Rate < 100pps
- Patient informed consent must be obtained
Who cannot join
- Not responding to pain stimuli (Hypoalgesia)
- Over responding to pain stimuli (Hyperalgesia)
- Classifying non pain stimuli as painful event (Allodynia)
- Medication/drugs were taken in the last week
- Usage of chronic medication in the last 3 months (not including contraceptive pills)
- Alcohol usage during the last 48 hours
Show all 9Show fewer
- Caffeine in the last 3 hours
- Pregnant women
- Inability to comply with the study protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-blind Randomized Clinical Trial to Assess the Efficacy of the Medasense's Non-Invasive Pain Monitor in Estimating the Pain Level Comparing to the Pain Stimuli and the Reported Pain Level on Healthy Subjects.
The clinical trial is intended to implement, validate performances and evaluate efficacy of the pain monitoring device for automated assessment of patient's pain level. The efficacy of the pain monitor will be tested by comparing its results to the patient pain reports towards a given pain stimuli.
Read the detailed description
Pain is an unpleasant sensation, ranging from slight discomfort to intense suffering. However, since a great extent of pain is a subjective phenomenon, it has frequently defied objective, quantitative measurement. Traditionally, physicians have had to assess a patient's pain by relying on the patient's own description. Self-description is not only subjective by definition; it is often inaccurate, in part because it is difficult for subjects to precisely articulate their pain while in the midst of a pain experience. Moreover, the report might be impossible when the subject cannot communicate
Presently, in order to quantify pain, the care provider asks the patient to rate his/her pain intensity using one-dimensional scale usually scored from 0 to 10. This scale is known as Numeric Pain Scale. This and other measures are used by the care providers to estimate the correct treatment dose and or to track a treatment progress. Due to its impact on care provider decision to prescribe painkiller mediation, some patients also intentionally misrepresent the existence or extent of their pain. Yet, without any reliable basis for denying such prescriptions, physicians generally must assume that the claims are truthful, even when they may suspect a lack of sincerity. Otherwise, the care provider may be accused of inhumane treatment. Conversely, other patients may underreport their pain, again for a variety of reasons.
The presented clinical trial is intended to implement, validate performances and evaluate efficacy of the pain monitoring device for automated assessment of patient's pain level. During the trial, up to 100 healthy young adults will be voluntarily inflicted by pain stimuli. The pain stimuli will be thermal heat pain stimulus and cold water pain stimulus applied with different intensities. Plurality of Non-Invasive Physiological Measurements will be recorded from volunteers and their Numeric Pain Scale reports will be monitored before, during and after the pain induction. Additional information such as age, gender, ethnicity, etc. will be collected as well. The collected database will be used to implement the algorithm that applies modern signal processing and machine learning methods in order to differentiate between different pain levels. The algorithm will be later integrated into pain monitoring device. The efficacy of the algorithm of the pain monitor will be tested by comparing its results to the patient pain reports towards a given pain stimuli.
- Conditions
- Pain
- Being tested
- Scanlaf Circulator and water bath, Medoc TSA 2000
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scanlaf Circulator and water bathDevice
Also called Open Cold Water Bath
Cold Pressor Test
Medoc TSA 2000Device
Also called Medoc Advanced Medical Systems TSA-II System
Thermal stimuli pain
| Study group | Role | What they receive |
|---|---|---|
| Pain/No Pain Stimuli | Experimental | One Arm is used in this trial. The comparator is within the arm. The different types of stimuli levels and types are compared. Receives: Device: Scanlaf Circulator and water bath; Device: Medoc TSA 2000 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison between the pain monitoring device results and the subjective pain report measured by the numeric pain scale to a given pain stimulus (heat and cold)
Measured: one year
Secondary outcomes (1)
Collect database to implement the algorithm for the pain monitor to differ between different pain levels.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2009 (estimated)
- Study startNov 2008
- Primary completionOct 2009
- Study completionOct 2009
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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medasense Biometrics Ltd
- Sponsor type
- University, hospital or other
- Investigators
- Elon Eisenberg, Prof., Principal investigator, Pain Relief Unit, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00914173
- Sponsor's protocol ID
- Medasense001
- Status last verified
- Jan 2010
- First submitted
- 3 Jun 2009
- Last updated
- 28 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-blind Randomized Clinical Trial to Assess the Efficacy of the Medasense's Non-Invasive Pain Monitor in Estimating the Pain Level Comparing to the Pain Stimuli and the Reported Pain Level on Healthy Subjects.
- ClinicalTrials.gov ID
- NCT00914173
- Acronym / sponsor ID
- Medasense001
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Medasense Biometrics LtdUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 4 Jun 2009 (estimated)
- 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.
The clinical trial is intended to implement, validate performances and evaluate efficacy of the pain monitoring device for automated assessment of patient's pain level. The efficacy of the pain monitor will be tested by comparing its results to the patient pain reports towards a given pain stimuli.
Detailed description
Pain is an unpleasant sensation, ranging from slight discomfort to intense suffering. However, since a great extent of pain is a subjective phenomenon, it has frequently defied objective, quantitative measurement. Traditionally, physicians have had to assess a patient's pain by relying on the patient's own description. Self-description is not only subjective by definition; it is often inaccurate, in part because it is difficult for subjects to precisely articulate their pain while in the midst of a pain experience. Moreover, the report might be impossible when the subject cannot communicate
Presently, in order to quantify pain, the care provider asks the patient to rate his/her pain intensity using one-dimensional scale usually scored from 0 to 10. This scale is known as Numeric Pain Scale. This and other measures are used by the care providers to estimate the correct treatment dose and or to track a treatment progress. Due to its impact on care provider decision to prescribe painkiller mediation, some patients also intentionally misrepresent the existence or extent of their pain. Yet, without any reliable basis for denying such prescriptions, physicians generally must assume that the claims are truthful, even when they may suspect a lack of sincerity. Otherwise, the care provider may be accused of inhumane treatment. Conversely, other patients may underreport their pain, again for a variety of reasons.
The presented clinical trial is intended to implement, validate performances and evaluate efficacy of the pain monitoring device for automated assessment of patient's pain level. During the trial, up to 100 healthy young adults will be voluntarily inflicted by pain stimuli. The pain stimuli will be thermal heat pain stimulus and cold water pain stimulus applied with different intensities. Plurality of Non-Invasive Physiological Measurements will be recorded from volunteers and their Numeric Pain Scale reports will be monitored before, during and after the pain induction. Additional information such as age, gender, ethnicity, etc. will be collected as well. The collected database will be used to implement the algorithm that applies modern signal processing and machine learning methods in order to differentiate between different pain levels. The algorithm will be later integrated into pain monitoring device. The efficacy of the algorithm of the pain monitor will be tested by comparing its results to the patient pain reports towards a given pain stimuli.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pain/No Pain Stimuli | Experimental | Device: Scanlaf Circulator and water bath, Device: Medoc TSA 2000One Arm is used in this trial. The comparator is within the arm. The different types of stimuli levels and types are compared. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy participant that response to pain stimuli
- Blood Pressure < (90,140), Heart Rate < 100pps
- Patient informed consent must be obtained
Key exclusion criteria (9 listed)
- Not responding to pain stimuli (Hypoalgesia)
- Over responding to pain stimuli (Hyperalgesia)
- Classifying non pain stimuli as painful event (Allodynia)
- Medication/drugs were taken in the last week
- Usage of chronic medication in the last 3 months (not including contraceptive pills)
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 |
|---|---|---|
| Scanlaf Circulator and water bathAlso: Open Cold Water BathCold Pressor Test | Device | Pain/No Pain Stimuli |
| Medoc TSA 2000Also: Medoc Advanced Medical Systems TSA-II SystemThermal stimuli pain | Device | Pain/No Pain Stimuli |
Primary outcome
Comparison between the pain monitoring device results and the subjective pain report measured by the numeric pain scale to a given pain stimulus (heat and cold)
Time frame: one year
1 secondary outcome
Collect database to implement the algorithm for the pain monitor to differ between different pain levels.
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2010.
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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.
Elon Eisenberg, Prof. principal investigator
Pain Relief Unit, Rambam Health Care Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scanlaf Circulator and water bath and Medoc TSA 2000 in people with Pain, run by Medasense Biometrics Ltd at 1 site in Israel.
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 9 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: finished, as of the sponsor's last update on 28 Jan 2010. 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 Israel. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison between the pain monitoring device results and the subjective pain report measured by the numeric pain scale to a given pain stimulus (heat and cold) (time frame: one year). 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 28 Jan 2010.