The Power of Touch. Non-Invasive C-Tactile Stimulation for Chronic Osteoarthritis Pain

NACompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

July 6, 2023

Primary Completion Date

April 9, 2025

Study Completion Date

May 7, 2025

Conditions
Chronic Pain
Interventions
DEVICE

Interoceptive stimulation treatment with mechanical stimulation of C-LTMRs afferences

The intervention is a non-invasive interoceptive stimulation (affective touch) delivered to the left volar forearm. The stimulation is delivered using a device with a small tactile probe that touches the skin in a circular motion. The device is designed to induce maximum firing frequency in the peripheral C-Ts nervous afferents, which respond to low-force, low-velocity stimuli, specifically 3 cm/sec, 2.5mN. The stimulation will be delivered in 18 blocks, each consisting of 6 short periods of stimulation of varying durations presented in random order, with pauses of 6 seconds after every single stimulation, the entire stimulation protocol will have a total duration of 30 minutes.

DEVICE

Sham treatment

In the sham condition, patients will receive a similar stimulation with the interoceptive tactile device, however, the device will be turned on for only 3 seconds every minute, and consequently turned off for 57 seconds. The entire duration of the stimulation will be approximately 30 minutes, similar to the experimental condition.

Trial Locations (1)

20145

Cosimo Tuena, Milan

All Listed Sponsors
lead

Istituto Auxologico Italiano

OTHER