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

Chronic Pain Clinical Trial

— TouchStim  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06060028
• Other study ID #: 39A101
• Status: Recruiting
• Phase: N/A
• Start date: September 30, 2023
• Est. completion date: June 2025

Study information

• Verified date: October 2023
• Source: Istituto Auxologico Italiano
• Contact: Daniele Di Lernia
• Phone: +393922267850
• Email: daniele.dilernia[@]unicatt.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2025
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain
• Osteoarthritis

Intervention

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 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.

Locations

Country	Name	City	State
Italy	Cosimo Tuena	Milan	Lombardia

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Auxologico Italiano

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	rescue analgesic medication intake	change of amount of rescue analgesic medication intake (the lower the better)	the change from baseline to week 12
Other	change in sympathetic activity	change in sympathetic activity (Low-Frequency power band index)	the change pre-intervention and immediately after the intervention
Other	Short term changes of inflammatory cytokine and hormone plasmatic levels	Interleukin-10 (IL-10), Tumor necrosis factor alpha or TNF-a, interleukin 1 family of cytokine or IL-1ß, Interleukin-6(IL-6),Interleukin-4 (IL4), cortisol and oxytocin	the change pre-intervention and immediately after the intervention
Other	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
Other	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
Other	change in parasympathetic activity	change in parasympathetic activity (rMSSD index)	the change pre-intervention and immediately after the intervention
Other	change in parasympathetic	change in parasympathetic (HighFrequency power band index)	the change pre-intervention and immediately after the intervention
Primary	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
Primary	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).
Primary	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	Long term changes of inflammatory cytokine plasmatic levels	Interleukin-10 (IL-10), Tumor necrosis factor alpha or TNF-a, interleukin 1 family of cytokine, IL-1ß, Interleukin-6 (IL-6), Interleukin-4 (IL4)	the change from baseline to week 12
Secondary	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