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

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT01659073` - Using Perfusion MRI to Measure the Dynamic Changes in Neural Activation Associated With Caloric Vestibular Stimulation	N/A
Recruiting	`NCT05914311` - Use of Dermabond in Mitigation of Spinal Cord Stimulation (SCS) Trial Lead Migration	N/A
Recruiting	`NCT05422456` - The Turkish Version of Functional Disability Inventory
Enrolling by invitation	`NCT05422443` - The Turkish Version of Pain Coping Questionnaire
Completed	`NCT05057988` - Virtual Empowered Relief for Chronic Pain	N/A
Completed	`NCT04385030` - Neurostimulation and Mirror Therapy in Traumatic Brachial Plexus Injury	N/A
Recruiting	`NCT06206252` - Can Medical Cannabis Affect Opioid Use?
Completed	`NCT05103319` - Simultaneous Application of Ketamine and Lidocaine During an Ambulatory Infusion Therapy as a Treatment Option in Refractory Chronic Pain Conditions
Completed	`NCT03687762` - Back on Track to Healthy Living Study	N/A
Completed	`NCT04171336` - Animal-assisted Therapy for Children and Adolescents With Chronic Pain	N/A
Completed	`NCT03179475` - Targin® for Chronic Pain Management in Patients With Spinal Cord Injury	Phase 4
Completed	`NCT03418129` - Neuromodulatory Treatments for Pain Management in TBI	N/A
Completed	`NCT03268551` - MEMO-Medical Marijuana and Opioids Study
Recruiting	`NCT06204627` - TDCS* and Laterality Trainnning in Patients With Chronic Neck Pain	N/A
Completed	`NCT05496205` - A SAD Study to Evaluate the Safety, Tolerability and PK/PD of iN1011-N17 in Healthy Volunteers	Phase 1
Completed	`NCT00983385` - Evaluation of Effectiveness and Tolerability of Tapentadol Hydrochloride in Subjects With Severe Chronic Low Back Pain Taking Either WHO Step I or Step II Analgesics or no Regular Analgesics	Phase 3
Recruiting	`NCT05118204` - Randomized Trial of Buprenorphine Microdose Inductions During Hospitalization	Phase 4
Terminated	`NCT03538444` - Repetitive Transcranial Magnetic Stimulation for Opiate Use Disorder	N/A
Not yet recruiting	`NCT05812703` - Biometrics and Self-reported Health Changes in Adults Receiving Behavioral Treatments for Chronic Pain
Completed	`NCT05036499` - PFI for Pain-Related Anxiety Among Hazardous Drinkers With Chronic Pain	N/A

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