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

Status Recruiting

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).

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06060028
Study type	Interventional
Source	Istituto Auxologico Italiano
Contact	Daniele Di Lernia
Phone	+393922267850
Email	daniele.dilernia@unicatt.it
Status	Recruiting
Phase	N/A
Start date	September 30, 2023
Completion date	June 2025

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms