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

The Power of Touch. Randomized,Double-blind, Sham-controlled Crossover Trial of Interoceptive Non-invasive Tactile Stimulation for the Treatment of Osteoarthritis Chronic Associated Pain

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).

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Device: Interoceptive stimulation treatment with mechanical stimulation of C-LTMRs afferences; Device: Sham treatment

Detailed Description

The current study aims to assess the long-term analgesic efficacy of interoceptive tactile stimulation in patients suffering from chronic moderate-to-severe osteoarthritis (OA) pain. The study will be a randomized, double-blind, sham-controlled crossover trial involving 60 OA patients with moderate-to-severe chronic pain. Patients will be randomly assigned to the treatment or control group and received interoceptive (affective touch) or control stimulation two days a week for 12 weeks. Patient will then undergo to a 4-week washout period, after that they will be assigned to the crossover treatment for another 12 weeks. The study will measure changes in pain and physical function, heart rate variability, as well as inflammatory and anti-inflammatory cytokines and medication intake, assessed at baseline, and at the end of each crossover phase. Follow-up measures will be assessed 4 weeks after the end of each crossover phase. Intermediate outcomes for pain and physical function, heart rate variability and medication intake will also be assessed after 4 and 8 weeks.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Lombardia
    • Milan, Lombardia, Italy, 20145
      • Cosimo Tuena

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: General Practitioner (GP) care plus interoceptive non-invasive tactile stimulation treatment; 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; 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.
Sham Comparator: GP care plus sham treatment; Participants will receive General Practitioner (GP) care and a sham stimulation for 30 min two times a week for 12 weeks.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Long term changes of inflammatory cytokine plasmatic levels	Interleukin-10 (IL-10), Tumor necrosis factor alpha or TNF-α, interleukin 1 family of cytokine, IL-1β, Interleukin-6 (IL-6), Interleukin-4 (IL4)	the change from baseline to week 12
Long term changes of stress/pain/anxiety-related hormone plasmatic levels cortisol and oxytocin	IL-10 and IL-4	the change from baseline to week 12

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
joint pain scores	Pain Numeric Rating Scale (NRS). Minimum score 0 (no pain); maximum score 10 (worst pain imaginable). The higher the score the higher the pain.	the change pre-intervention and immediately after the intervention
rescue analgesic medication intake	change of amount of rescue analgesic medication intake (the lower the better)	the change from baseline to week 12
change in sympathetic activity	change in sympathetic activity (Low-Frequency power band index)	the change pre-intervention and immediately after the intervention
Short term changes of inflammatory cytokine and hormone plasmatic levels	Interleukin-10 (IL-10), Tumor necrosis factor alpha or TNF-α, interleukin 1 family of cytokine or IL-1β, Interleukin-6(IL-6),Interleukin-4 (IL4), cortisol and oxytocin	the change pre-intervention and immediately after the intervention
the percentage of patients who responded to Western Ontario and McMaster Universities (WOMAC)	the percentage of patients who responded to treatment according to ≥30% and ≥50% changes at week 12 in the WOMAC pain and physical function subscale scores.	changes at week 12
pain diary	Pain weekly measures will be collected with a pain diary two days a week. In the dairy, patients will report pain ratings on the WOMAC pain subscale, to keep track of sudden variations in the symptomatology (i.e., flares) in the 48 hours preceding the treatment sessions.	two days a week in the 48 hours preceding the treatment sessions
change in parasympathetic activity	change in parasympathetic activity (rMSSD index)	the change pre-intervention and immediately after the intervention
change in parasympathetic	change in parasympathetic (HighFrequency power band index)	the change pre-intervention and immediately after the intervention

Collaborators and Investigators

• Sponsor: Istituto Auxologico Italiano
• Investigators: Principal Investigator: Daniele Di Lernia, Catholic University of the Sacred Heart of Milan

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2023
• Primary Completion (Actual): April 9, 2025
• Study Completion (Actual): May 7, 2025

Study Registration Dates

• First Submitted: September 7, 2023
• First Submitted That Met QC Criteria: September 22, 2023
• First Posted (Actual): September 29, 2023

Study Record Updates

• Last Update Posted (Estimated): May 20, 2025
• Last Update Submitted That Met QC Criteria: May 19, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Chronic Pain
• Other Study ID Numbers: 39A101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No