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

NCT06060028 | Completed

• 1 other identifier: 39A101
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Chronic Pain

Outcome Measures

Primary Outcomes (3)

• the pain subscale scores from Western Ontario and McMaster Universities OA Index (WOMAC)

  A higher WOMAC score represented worse symptom severity. Measures are assessed in a modified intention-to treat population for all participants randomly assigned to groups and who attended a baseline visit.

  the change from baseline to week 12 in the pain subscale scores of the WOMAC

• the physical function subscale scores of the Western Ontario and McMaster Universities OA Index (WOMAC)

  A higher WOMAC score represented worse symptom severity. Measures are assessed in a modified intention-to treat population for all participants randomly assigned to groups and who attended a baseline visit.

  Will be the change from baseline to week 12 in the physical function subscale scores of the Western Ontario and McMaster Universities OA Index (WOMAC).

• the patient global assessment (PGA) of osteoarthritis.

  Measures are assessed in a modified intention-to treat population for all participants randomly assigned to groups and who attended a baseline visit.

  Will be the change from baseline to week 12 in the patient global assessment (PGA)

Secondary Outcomes (2)

• Long term changes of inflammatory cytokine plasmatic levels

  the change from baseline to week 12

• Long term changes of stress/pain/anxiety-related hormone plasmatic levels cortisol and oxytocin

  the change from baseline to week 12

Other Outcomes (8)

• joint pain scores

  the change pre-intervention and immediately after the intervention

• rescue analgesic medication intake

  the change from baseline to week 12

• change in sympathetic activity

  the change pre-intervention and immediately after the intervention

Study Arms (2)

General Practitioner (GP) care plus interoceptive non-invasive tactile stimulation treatment

EXPERIMENTAL

Participants will receive General Practitioner (GP) care and interoceptive non-invasive tactile stimulation (affective touch) for 30 min two times a week for 12 weeks.

Device: Interoceptive stimulation treatment with mechanical stimulation of C-LTMRs afferences

GP care plus sham treatment

SHAM COMPARATOR

Participants will receive General Practitioner (GP) care and a sham stimulation for 30 min two times a week for 12 weeks.

Device: Sham treatment

Interventions

Interoceptive stimulation treatment with mechanical stimulation of C-LTMRs afferences DEVICE

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.

General Practitioner (GP) care plus interoceptive non-invasive tactile stimulation treatment

Sham treatment DEVICE

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.

GP care plus sham treatment

Eligibility Criteria

• Age: 45 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• osteoarthritis patients
• Age 45-90
• Diagnosis of OA ACR criteria
• Moderate-to-severe OA chronic pain.

You may not qualify if:

• other joint diseases
• trauma, or pain condition
• fibromyalgia
• BMI\>39 kg/m2.

Sponsors & Collaborators

• Istituto Auxologico Italiano: lead

Study Sites (1)

Cosimo Tuena

Milan, Lombardy, 20145, Italy

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Daniele Di Lernia

  Catholic University of the Sacred Heart of Milan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2023
• First Posted: September 29, 2023
• Study Start: July 6, 2023
• Primary Completion: April 9, 2025
• Study Completion: May 7, 2025
• Last Updated: May 20, 2025

Record last verified: 2025-05

Locations

IT (1)