The Power of Touch. Non-Invasive C-Tactile Stimulation for Chronic Osteoarthritis Pain
- Conditions
- Chronic Pain
- Interventions
- Device: Interoceptive stimulation treatment with mechanical stimulation of C-LTMRs afferencesDevice: Sham treatment
- Registration Number
- NCT06060028
- Lead Sponsor
- Istituto Auxologico Italiano
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- osteoarthritis patients
- Age 45-90
- Diagnosis of OA ACR criteria
- Moderate-to-severe OA chronic pain.
- other joint diseases
- trauma, or pain condition
- fibromyalgia
- BMI>39 kg/m2.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description General Practitioner (GP) care plus interoceptive non-invasive tactile stimulation treatment Interoceptive stimulation treatment with mechanical stimulation of C-LTMRs afferences 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. GP care plus sham treatment Sham treatment Participants will receive General Practitioner (GP) care and a sham stimulation for 30 min two times a week for 12 weeks.
- Primary Outcome Measures
Name Time Method the pain subscale scores from Western Ontario and McMaster Universities OA Index (WOMAC) 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. 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) 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 Outcome Measures
Name Time Method Long term changes of inflammatory cytokine plasmatic levels the change from baseline to week 12 Interleukin-10 (IL-10), Tumor necrosis factor alpha or TNF-α, interleukin 1 family of cytokine, IL-1β, Interleukin-6 (IL-6), Interleukin-4 (IL4)
Long term changes of stress/pain/anxiety-related hormone plasmatic levels cortisol and oxytocin the change from baseline to week 12 IL-10 and IL-4
Trial Locations
- Locations (1)
Cosimo Tuena
🇮🇹Milan, Lombardia, Italy