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

Istituto Auxologico Italiano1 site in 1 country60 target enrollmentJuly 6, 2023

Overview

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).

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.

Registry

clinicaltrials.gov

Start Date

July 6, 2023

End Date

May 7, 2025

Last Updated

11 months ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Istituto Auxologico Italiano

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

Time Frame: the change from baseline to week 12 in the pain subscale scores of the 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 patient global assessment (PGA) of osteoarthritis.

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

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

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

Time Frame: 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).

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.

Secondary Outcomes

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)