Clinical trial NCT06060028: The Power of Touch. Non-Invasive C-Tactile Stimulation for Chronic Osteoarthritis Pain
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
First posted: 2023-09-29
Enrollment: 60
Sex: ALL
Minimum age (years): 45
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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).

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.

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.

Primary outcomes:
measure: the pain subscale scores from Western Ontario and McMaster Universities OA Index (WOMAC)
timeFrame: the change from baseline to week 12 in the pain subscale scores of the WOMAC
measure: the physical function subscale scores of the Western Ontario and McMaster Universities OA Index (WOMAC)
timeFrame: 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).
measure: the patient global assessment (PGA) of osteoarthritis.
timeFrame: Will be the change from baseline to week 12 in the patient global assessment (PGA)
Secondary outcomes:
measure: Long term changes of inflammatory cytokine plasmatic levels
timeFrame: the change from baseline to week 12
measure: Long term changes of stress/pain/anxiety-related hormone plasmatic levels cortisol and oxytocin
timeFrame: the change from baseline to week 12
Other outcomes:
measure: joint pain scores
timeFrame: the change pre-intervention and immediately after the intervention
measure: rescue analgesic medication intake
timeFrame: the change from baseline to week 12
measure: change in sympathetic activity
timeFrame: the change pre-intervention and immediately after the intervention
measure: Short term changes of inflammatory cytokine and hormone plasmatic levels
timeFrame: the change pre-intervention and immediately after the intervention
measure: the percentage of patients who responded to Western Ontario and McMaster Universities (WOMAC)
timeFrame: changes at week 12
measure: pain diary
timeFrame: two days a week in the 48 hours preceding the treatment sessions
measure: change in parasympathetic activity
timeFrame: the change pre-intervention and immediately after the intervention
measure: change in parasympathetic
timeFrame: the change pre-intervention and immediately after the intervention
Locations:
city: Milan
country: Italy
facility: Cosimo Tuena
state: Lombardia
Study officials:
affiliation: Catholic University of the Sacred Heart of Milan
name: Daniele Di Lernia
role: PRINCIPAL_INVESTIGATOR
References: