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COMPLETED
NCT07774429
NA

Evaluation of Psychophysical Responses After Mechanical Stimulation: a Reliability Study

Sponsor: National Council of Scientific and Technical Research, Argentina

View on ClinicalTrials.gov

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 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.

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

33

Start Date

2026-06-01

Completion Date

2026-08-01

Last Updated

2026-08-19

Healthy Volunteers

Yes

Interventions

OTHER

Robot-controlled non-injurious mechanical stimulation

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.

Locations (1)

Facultad de Ingeniería, UNER

Oro Verde, Entre Ríos Province, Argentina