Pain ThresholdsNCT07774429
Evaluation of Psychophysical Responses After Mechanical Stimulation.
A study of Pain Thresholds and Healthy Adult Participants, run by National Council of Scientific and Technical Research, Argentina at 1 site in Argentina.
Trial summary
This study evaluates the test-retest reliability of psychophysical responses to non-injurious sharp stimuli applied via a robotic system. The accurate assessment of acute mechanical pain, such as the pain associated with surgical incisions or non-suicidal self-injury, is challenging due to the subjectivity of pain and… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain Thresholds, Healthy Adult Participants
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteArgentina
- Study dates
- 1 Jun 2026to 1 Aug 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18 and 60 years.
- No history of chronic pain, neuromuscular disorders, or any disease that affects the nociceptive system and prevents its evaluation under normal conditions.
- Willingness and ability to fully understand the content and scope of the experiment and to comply with its instructions.
- Having signed the informed consent.
Who cannot join
- Pregnancy.
- History of chronic pain, neuromuscular disorders, or any disease that affects the nociceptive system and prevents its evaluation under normal conditions.
- History of addictive behavior, defined as abuse of alcohol, cannabis, opioids, or other drugs.
- History of mental illnesses.
- Presence of fever, tuberculosis, malignant tumors, infectious processes, or acute inflammatory processes.
- Use of analgesics within 24 hours prior to participation in the experiment.
- Skin lesions, scars, or dermatological conditions in the area of stimulus application.
- Lack of cooperation.
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Facultad de Ingeniería, UNER
Oro Verde, Entre Ríos Province, 3100
About this study
Official title: Evaluation of Psychophysical Responses After Mechanical Stimulation: a Reliability Study
This study evaluates the test-retest reliability of psychophysical responses to non-injurious sharp stimuli applied via a robotic system. The accurate assessment of acute mechanical pain, such as the pain associated with surgical incisions or non-suicidal self-injury, is challenging due to the subjectivity of pain and the risk of tissue damage with traditional mechanical stimulation methods. To overcome this barrier, researchers have developed a non-injurious sharp blade model that mimics the sensory characteristics of incisional pain without causing tissue damage. However, manual application of this blade introduces operator-dependent variability in force, speed, and duration. This study utilizes a novel robotic stimulator equipped with a non-injurious blade to deliver controlled stimuli. The experimental design involves healthy adult volunteers with two identical testing sessions separated by a minimum interval of 48 hours. During these sessions, participants undergo quantitative sensory testing (QST), including the evaluation of pain and tolerance thresholds using the robotic system on the ventral forearm. Additional measurements include pain threshold to pinprick stimulation, muscle stiffness, pain catastrophizing (Sullivan et al., 1995), and conditioned pain modulation.
These results will establish the precision and reliability of this robotic system that are required for further clinical and experimental pain research.
Read the detailed description
Pain is a global health problem involving physiological, psychological, and contextual dimensions that complicate its objective and reproducible evaluation, even in well-controlled environments. Acute mechanical pain, particularly pain associated with surgical incisions or cutting lesions, is of special clinical relevance. It constitutes a central component of postoperative pain and is frequently observed in non-suicidal self-injury contexts. Specifically, in individuals with Borderline Personality Disorder (BPD), over 80% report the use of cutting as an emotional tension regulation strategy. Given the complexity of evaluating this phenomenon, standardized Quantitative Sensory Testing (QST) is essential to determine the state of the somatosensory system in both patients and experimental models. QST measures the intensity at which a stimulus produces a specific sensory perception. However, traditional mechanical QST modalities (e.g., von Frey filaments, pinprick) have a critical limitation: strong stimuli can provoke actual tissue damage. To address this, a non-injurious sharp blade model was developed, allowing the reproduction of the initial sensory characteristics of incisional pain without causing injury (such as sharp pain, primary, and secondary hyperalgesia). While this model has been successfully tested in healthy volunteers and BPD patients, its manual application depends heavily on the operator, leading to involuntary fluctuations in speed, force, and duration. To solve this, a robotic system can apply these controlled mechanical stimuli, increasing precision, controlling the applied force, and allowing exact synchronization with electrophysiological recordings. The recent incorporation of an interchangeable head featuring the non-injurious blade model enables the first-ever exploration of non-injurious sharp mechanical stimulation applied via robotics.
The primary objective of this protocol is to evaluate the reliability of psychophysical responses to non-injurious sharp stimuli applied by the robotic system.
The sample size was determined based on the desired precision for estimating the repeatability of the system. Specifically, the objective was to estimate the within-subject standard deviation. The precision with which we can estimate the standard deviation depends on both the number of subjects N and the number of observations per subject M with a 95% confidence interval and a margin of error of ±25% was proposed, from which it is determined that the participation of N = 31 volunteers and M = 2 observations per volunteer is required. To account for a potential 5% dropout rate, the final recruited sample size is N = 33. The volunteers undergo two identical sessions: a baseline session and a re-evaluation session, separated by an interval of at least 48 hours.
During each sessions, the following procedures will be conducted:
Pain Catastrophizing Scale (PCS): A 13-item self-administered questionnaire (scored on a 0-4 Likert scale) to measure negative and exaggerated coping related to pain experiences, specifically assessing hopelessness, magnification, and rumination.
Muscle Stiffness: Non-invasive evaluation using a portable device (MyotonPRO) applying brief (15 ms) mechanical stimuli to automatically calculate muscle tone, stiffness, and elasticity in the forearm.
Pinprick Pain Threshold: Measured using a customized system
Robot-Controlled Blade Thresholds: The robotic system will apply the non-injurious blade (4 mm x 0.1 mm) to the ventral forearm at a constant speed of 5 mm/s. Following a familiarization stage, participants will use a push-button to indicate their Pain Threshold (when the tactile sensation becomes distinctly painful) and Tolerance Threshold (when the pain becomes unbearable or reaches the 5000 mN safety limit).
Conditioned Pain Modulation (CPM): After establishing baseline blade pain thresholds, participants will submerge their dominant hand up to the wrist in a cold water bath maintained below 4°C for up to two minutes. During immersion, participants will continuously rate their pain on a computerized Visual Analog Scale (VAS) from 0 to 100. Immediately after withdrawing the hand, the robotic blade thresholds will be re-evaluated to measure the descending pain inhibition system.
- Conditions
- Pain Thresholds, Healthy Adult Participants
- Being tested
- Robot-controlled non-injurious mechanical stimulation
- Keywords
- Quantitative Sensory Testing (QST), Robotic Stimulation, Pain Threshold, Mechanical Pain, Non-injurious Blade, Conditioned Pain Modulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot-controlled non-injurious mechanical stimulationOther
Application of controlled mechanical stimuli using a robotic system equipped with a non-injurious blade head (4 mm x 0.1 mm). The system applies progressive force at a constant speed of 5 mm/s on the ventral forearm to determine pain and tolerance thresholds.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Experimental | Healthy adult volunteers aged 18 to 60 will receive mechanical stimulation across two identical sessions. Receives: Other: Robot-controlled non-injurious mechanical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Threshold
The amount of force (in grams) at which a tactile sensation is perceived as painful, assessed using the robot-controlled non-injurious blade.
Measured: Day 1 and Day 3
Secondary outcomes (2)
Conditioned Pain Modulation effect on non-injurious blade pain threshold
The difference in non-injurious blade pain thresholds (in grams) measured before and immediately after the application of a cold-water conditioning stimulus. A positive difference indicates an effective descending pain inhibition response.
Measured: Day 1 and Day 3
Pinprick Pain Threshold
The amount of force (in grams) at which a tactile sensation is perceived as painful, assessed using a customized device stimulator, as a secondary comparison measure to the robot-controlled blade.
Measured: Day 1 and Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start1 Jun 2026
- Primary completion1 Aug 2026
- Study completion1 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ThresholdsStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Council of Scientific and Technical Research, Argentina
- Sponsor type
- Other government
- Collaborators
- Universidad Nacional de Entre Rios
- Responsible party
- Principal investigator, Christian Mista, National Council of Scientific and Technical Research, Argentina
- Investigators
- Christian Mista, Principal investigator, National Council of Scientific and Technical Research, Argentina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07774429
- Sponsor's protocol ID
- IS005392
- Status last verified
- Aug 2026
- First submitted
- 30 Jul 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Psychophysical Responses After Mechanical Stimulation: a Reliability Study
- ClinicalTrials.gov ID
- NCT07774429
- Acronym / sponsor ID
- IS005392
- Conditions
- Pain Thresholds, Healthy Adult Participants
- Keywords
- Quantitative Sensory Testing (QST), Robotic Stimulation, Pain Threshold, Mechanical Pain, Non-injurious Blade, Conditioned Pain Modulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- National Council of Scientific and Technical Research, ArgentinaOther government
- Collaborators
- Universidad Nacional de Entre Rios
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 1 Aug 2026 (actual)
- Study completion
- 1 Aug 2026 (actual)
- First posted
- 19 Aug 2026 (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 study evaluates the test-retest reliability of psychophysical responses to non-injurious sharp stimuli applied via a robotic system. The accurate assessment of acute mechanical pain, such as the pain associated with surgical incisions or non-suicidal self-injury, is challenging due to the subjectivity of pain and the risk of tissue damage with traditional mechanical stimulation methods. To overcome this barrier, researchers have developed a non-injurious sharp blade model that mimics the sensory characteristics of incisional pain without causing tissue damage. However, manual application of this blade introduces operator-dependent variability in force, speed, and duration. This study utilizes a novel robotic stimulator equipped with a non-injurious blade to deliver controlled stimuli. The experimental design involves healthy adult volunteers with two identical testing sessions separated by a minimum interval of 48 hours. During these sessions, participants undergo quantitative sensory testing (QST), including the evaluation of pain and tolerance thresholds using the robotic system on the ventral forearm. Additional measurements include pain threshold to pinprick stimulation, muscle stiffness, pain catastrophizing (Sullivan et al., 1995), and conditioned pain modulation.
These results will establish the precision and reliability of this robotic system that are required for further clinical and experimental pain research.
Detailed description
Pain is a global health problem involving physiological, psychological, and contextual dimensions that complicate its objective and reproducible evaluation, even in well-controlled environments. Acute mechanical pain, particularly pain associated with surgical incisions or cutting lesions, is of special clinical relevance. It constitutes a central component of postoperative pain and is frequently observed in non-suicidal self-injury contexts. Specifically, in individuals with Borderline Personality Disorder (BPD), over 80% report the use of cutting as an emotional tension regulation strategy. Given the complexity of evaluating this phenomenon, standardized Quantitative Sensory Testing (QST) is essential to determine the state of the somatosensory system in both patients and experimental models. QST measures the intensity at which a stimulus produces a specific sensory perception. However, traditional mechanical QST modalities (e.g., von Frey filaments, pinprick) have a critical limitation: strong stimuli can provoke actual tissue damage. To address this, a non-injurious sharp blade model was developed, allowing the reproduction of the initial sensory characteristics of incisional pain without causing injury (such as sharp pain, primary, and secondary hyperalgesia). While this model has been successfully tested in healthy volunteers and BPD patients, its manual application depends heavily on the operator, leading to involuntary fluctuations in speed, force, and duration. To solve this, a robotic system can apply these controlled mechanical stimuli, increasing precision, controlling the applied force, and allowing exact synchronization with electrophysiological recordings. The recent incorporation of an interchangeable head featuring the non-injurious blade model enables the first-ever exploration of non-injurious sharp mechanical stimulation applied via robotics.
The primary objective of this protocol is to evaluate the reliability of psychophysical responses to non-injurious sharp stimuli applied by the robotic system.
The sample size was determined based on the desired precision for estimating the repeatability of the system. Specifically, the objective was to estimate the within-subject standard deviation. The precision with which we can estimate the standard deviation depends on both the number of subjects N and the number of observations per subject M with a 95% confidence interval and a margin of error of ±25% was proposed, from which it is determined that the participation of N = 31 volunteers and M = 2 observations per volunteer is required. To account for a potential 5% dropout rate, the final recruited sample size is N = 33. The volunteers undergo two identical sessions: a baseline session and a re-evaluation session, separated by an interval of at least 48 hours.
During each sessions, the following procedures will be conducted:
Pain Catastrophizing Scale (PCS): A 13-item self-administered questionnaire (scored on a 0-4 Likert scale) to measure negative and exaggerated coping related to pain experiences, specifically assessing hopelessness, magnification, and rumination.
Muscle Stiffness: Non-invasive evaluation using a portable device (MyotonPRO) applying brief (15 ms) mechanical stimuli to automatically calculate muscle tone, stiffness, and elasticity in the forearm.
Pinprick Pain Threshold: Measured using a customized system
Robot-Controlled Blade Thresholds: The robotic system will apply the non-injurious blade (4 mm x 0.1 mm) to the ventral forearm at a constant speed of 5 mm/s. Following a familiarization stage, participants will use a push-button to indicate their Pain Threshold (when the tactile sensation becomes distinctly painful) and Tolerance Threshold (when the pain becomes unbearable or reaches the 5000 mN safety limit).
Conditioned Pain Modulation (CPM): After establishing baseline blade pain thresholds, participants will submerge their dominant hand up to the wrist in a cold water bath maintained below 4°C for up to two minutes. During immersion, participants will continuously rate their pain on a computerized Visual Analog Scale (VAS) from 0 to 100. Immediately after withdrawing the hand, the robotic blade thresholds will be re-evaluated to measure the descending pain inhibition system.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | Experimental | Other: Robot-controlled non-injurious mechanical stimulationHealthy adult volunteers aged 18 to 60 will receive mechanical stimulation across two identical sessions. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age between 18 and 60 years.
- No history of chronic pain, neuromuscular disorders, or any disease that affects the nociceptive system and prevents its evaluation under normal conditions.
- Willingness and ability to fully understand the content and scope of the experiment and to comply with its instructions.
- Having signed the informed consent.
Key exclusion criteria (8 listed)
- Pregnancy.
- History of chronic pain, neuromuscular disorders, or any disease that affects the nociceptive system and prevents its evaluation under normal conditions.
- History of addictive behavior, defined as abuse of alcohol, cannabis, opioids, or other drugs.
- History of mental illnesses.
- Presence of fever, tuberculosis, malignant tumors, infectious processes, or acute inflammatory processes.
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 |
|---|---|---|
| Robot-controlled non-injurious mechanical stimulationApplication of controlled mechanical stimuli using a robotic system equipped with a non-injurious blade head (4 mm x 0.1 mm). The system applies progressive force at a constant speed of 5 mm/s on the ventral forearm to determine pain and tolerance thresholds. | Other | Healthy Volunteers |
Primary outcome
Pain Threshold
Time frame: Day 1 and Day 3
The amount of force (in grams) at which a tactile sensation is perceived as painful, assessed using the robot-controlled non-injurious blade.
2 secondary outcomes
Conditioned Pain Modulation effect on non-injurious blade pain threshold
Time frame: Day 1 and Day 3
Pinprick Pain Threshold
Time frame: Day 1 and Day 3
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 24 Aug 2026.
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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.
Christian Mista principal investigator
National Council of Scientific and Technical Research, Argentina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Pain Thresholds and Healthy Adult Participants, run by National Council of Scientific and Technical Research, Argentina at 1 site in Argentina.
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 8 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 24 Aug 2026. 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 Argentina. 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?
Pain Threshold (time frame: Day 1 and Day 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 24 Aug 2026.