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

NCT06060028 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-05-20

No results posted yet for this study

Summary

Osteoarthritis (OA) is a degenerative disease with a prevalence of up to 30% among adults over 45 years old. Moreover, elderly people over 60 years are more prone to develop a chronification of pain symptomatology. Chronic pain in OA enormously restricts patients' ability to perform their daily activities, eliciting psychological distress and mood alterations, and producing massive socioeconomic consequences. For these reasons, any non-invasive drug-free treatment that decreases chronic pain in OA requires serious evaluation.

This study aims to investigate the effectiveness of noninvasive interoceptive stimulation (affective touch) in treating chronic pain associated with osteoarthritis (OA).

This study aims to investigate the effectiveness of noninvasive interoceptive stimulation (affective touch) in treating chronic pain associated with osteoarthritis (OA).

Conditions

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.

Sponsors & Collaborators

  • Istituto Auxologico Italiano

    lead OTHER

Principal Investigators

  • Daniele Di Lernia · Catholic University of the Sacred Heart of Milan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
45 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-06
Primary Completion
2025-04-09
Completion
2025-05-07

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06060028 on ClinicalTrials.gov