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

Istituto Auxologico Italiano

Status: Completed

Conditions: Chronic Pain

Treatments: Device: Interoceptive stimulation treatment with mechanical stimulation of C-LTMRs afferences; Device: Sham treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT06060028

39A101

Details and patient eligibility

About

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).

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 45 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

General Practitioner (GP) care plus interoceptive non-invasive tactile stimulation treatment

Experimental group

Description:

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.

Treatment:

Device: Interoceptive stimulation treatment with mechanical stimulation of C-LTMRs afferences

GP care plus sham treatment

Sham Comparator group

Description:

Participants will receive General Practitioner (GP) care and a sham stimulation for 30 min two times a week for 12 weeks.

Treatment:

Device: Sham treatment