Chronic PainTouchStimNCT06060028
The Power of Touch. Non-Invasive C-Tactile Stimulation for Chronic Osteoarthritis Pain
A study testing Interoceptive stimulation treatment with mechanical stimulation of C-LTMRs afferences in people with Chronic Pain, run by Istituto Auxologico Italiano at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 45 to 90 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Interoceptive stimulation treatment with mechanical stimulation of C-LTMRs afferences
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 6 Jul 2023to 7 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- osteoarthritis patients
- Age 45-90
- Diagnosis of OA ACR criteria
- Moderate-to-severe OA chronic pain.
Who cannot join
- other joint diseases
- trauma, or pain condition
- fibromyalgia
- BMI>39 kg/m2.
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read the 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.
- Conditions
- Chronic Pain
- Being tested
- Interoceptive stimulation treatment with mechanical stimulation of C-LTMRs afferences, Sham treatment
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interoceptive stimulation treatment with mechanical stimulation of C-LTMRs afferencesDevice
The intervention is a non-invasive interoceptive stimulation (affective touch) delivered to the left volar forearm. The stimulation is delivered using a device with a small tactile probe that touches the skin in a circular motion. The device is designed to induce maximum firing frequency in the peripheral C-Ts nervous afferents, which respond to low-force, low-velocity stimuli, specifically 3 cm/sec, 2.5mN. The stimulation will be delivered in 18 blocks, each consisting of 6 short periods of stimulation of varying durations presented in random order, with pauses of 6 seconds after every single stimulation, the entire stimulation protocol will have a total duration of 30 minutes.
Sham treatmentDevice
In the sham condition, patients will receive a similar stimulation with the interoceptive tactile device, however, the device will be turned on for only 3 seconds every minute, and consequently turned off for 57 seconds. The entire duration of the stimulation will be approximately 30 minutes, similar to the experimental condition.
| Study group | Role | What they receive |
|---|---|---|
| General Practitioner (GP) care plus interoceptive non-invasive tactile stimulation treatment | Experimental | 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. Receives: Device: Interoceptive stimulation treatment with mechanical stimulation of C-LTMRs afferences |
| GP care plus sham treatment | Sham comparator | Participants will receive General Practitioner (GP) care and a sham stimulation for 30 min two times a week for 12 weeks. Receives: Device: Sham treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
the pain subscale scores from 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.
Measured: the change from baseline to week 12 in the pain subscale scores of the WOMAC
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.
Measured: 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).
the patient global assessment (PGA) of osteoarthritis.
Measures are assessed in a modified intention-to treat population for all participants randomly assigned to groups and who attended a baseline visit.
Measured: Will be the change from baseline to week 12 in the patient global assessment (PGA)
Secondary outcomes (2)
Long term changes of inflammatory cytokine plasmatic levels
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)
Measured: the change from baseline to week 12
Long term changes of stress/pain/anxiety-related hormone plasmatic levels cortisol and oxytocin
IL-10 and IL-4
Measured: the change from baseline to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start6 Jul 2023
- Primary completion9 Apr 2025
- Study completion7 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Istituto Auxologico ItalianoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniele Di Lernia, Principal investigator, Catholic University of the Sacred Heart of Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06060028
- Sponsor's protocol ID
- 39A101
- Acronym
- TouchStim
- Status last verified
- May 2025
- First submitted
- 7 Sep 2023
- Last updated
- 20 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06060028
- Acronym / sponsor ID
- TouchStim / 39A101
- Conditions
- Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- 6 Jul 2023 (actual)
- Primary completion
- 9 Apr 2025 (actual)
- Study completion
- 7 May 2025 (actual)
- First posted
- 29 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General Practitioner (GP) care plus interoceptive non-invasive tactile stimulation treatment | Experimental | Device: Interoceptive stimulation treatment with mechanical stimulation of C-LTMRs afferencesParticipants 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 comparator | Device: Sham treatmentParticipants will receive General Practitioner (GP) care and a sham stimulation for 30 min two times a week for 12 weeks. |
Who may qualify
- Ages
- 45 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- osteoarthritis patients
- Age 45-90
- Diagnosis of OA ACR criteria
- Moderate-to-severe OA chronic pain.
Key exclusion criteria (4 listed)
- other joint diseases
- trauma, or pain condition
- fibromyalgia
- BMI>39 kg/m2.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interoceptive stimulation treatment with mechanical stimulation of C-LTMRs afferencesThe intervention is a non-invasive interoceptive stimulation (affective touch) delivered to the left volar forearm. The stimulation is delivered using a device with a small tactile probe that touches the skin in a circular motion. The device is designed to induce maximum firing frequency in the peripheral C-Ts nervous afferents, which respond to low-force, low-velocity stimuli, specifically 3 cm/sec, 2.5mN. The stimulation will be delivered in 18 blocks, each consisting of 6 short periods of stimulation of varying durations presented in random order, with pauses of 6 seconds after every single stimulation, the entire stimulation protocol will have a total duration of 30 minutes. | Device | General Practitioner (GP) care plus interoceptive non-invasive tactile stimulation treatment |
| Sham treatmentIn the sham condition, patients will receive a similar stimulation with the interoceptive tactile device, however, the device will be turned on for only 3 seconds every minute, and consequently turned off for 57 seconds. The entire duration of the stimulation will be approximately 30 minutes, similar to the experimental condition. | Device | GP care plus sham treatment |
Primary outcome
the pain subscale scores from Western Ontario and McMaster Universities OA Index (WOMAC)
Time frame: 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 physical function subscale scores of the Western Ontario and McMaster Universities OA Index (WOMAC)
Time frame: 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.
the patient global assessment (PGA) of osteoarthritis.
Time frame: 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.
2 secondary outcomes
Long term changes of inflammatory cytokine plasmatic levels
Time frame: the change from baseline to week 12
Long term changes of stress/pain/anxiety-related hormone plasmatic levels cortisol and oxytocin
Time frame: the change from baseline to week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
Related trials for Chronic Pain
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniele Di Lernia principal investigator
Catholic University of the Sacred Heart of Milan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interoceptive stimulation treatment with mechanical stimulation of C-LTMRs afferences in people with Chronic Pain, run by Istituto Auxologico Italiano at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the pain subscale scores from Western Ontario and McMaster Universities OA Index (WOMAC) (time frame: the change from baseline to week 12 in the pain subscale scores of the WOMAC). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2025.