Bluetooth Haptic Device for Pain

Overseen By Man Yee Suen, MMedSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Must not be taking: Beta blockers, Opioids

Disqualifiers: Chronic pain, Hearing loss, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a new Bluetooth Haptic Device (a wearable device using vibrations) can help manage pain. Participants will experience either an experimental vibrating frequency or a control frequency while receiving small pinpricks on their arms. The trial aims to determine how vibrations affect pain perception. It seeks healthy individuals with no history of chronic pain or neurological conditions and intact hearing.

As an unphased trial, this study offers participants the chance to contribute to innovative research that could lead to new pain management solutions.

Do I need to stop my current medications to join the trial?

Yes, you cannot participate if you are currently taking beta blockers, heart medications, or any prescription pain medications.

What prior data suggests that this Bluetooth Haptic Device is safe for evaluating pain thresholds?

Research has shown that the Bluetooth Haptic Device, which uses vibrations to interact with the skin, is generally safe. Studies have found that users tolerate this touch-based device well. Its advanced design ensures flexibility and safety, making it suitable for wearable technology. No reports of serious side effects have emerged from its use. This suggests the device is likely safe for healthy participants, as it aims to enhance comfort without causing harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Bluetooth Haptic Device for pain management because it offers a non-invasive option that uses vibration to potentially alleviate discomfort. Unlike traditional pain relief methods like medications or topical treatments, this device utilizes a novel approach by applying specific vibrating frequencies directly to the skin. This could minimize the need for drugs, reducing the risk of side effects and dependency. Additionally, the Bluetooth connectivity could allow for easy adjustment and customization of the device’s settings, making it a versatile option for individuals experiencing pain.

What evidence suggests that this Bluetooth Haptic Device is effective for pain?

Studies have shown promising results for the Bluetooth Haptic Device in managing pain. Research indicates that this device can significantly reduce pain by using vibrations to distract the brain from pain signals. In this trial, participants will be assigned to different arms to test the device's effectiveness. One arm will use the Bluetooth Haptic Device with an experimental vibrating frequency, while another will use a control vibrating frequency. A study found that patients using similar touch-based devices reported feeling less pain during medical procedures. Additionally, researchers are exploring these devices for reducing anxiety and distress, suggesting a calming effect that could aid in pain management. Overall, the Bluetooth Haptic Device's innovative approach to pain relief holds potential based on these initial findings. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults over 18 who speak English and have no hearing issues. It's not suitable for those with conditions that might interfere with the study or its results.

Inclusion Criteria

English speaking

I am over 18 years old.

My hearing is normal.

Exclusion Criteria

I have a history of long-term or sudden pain conditions.

I am currently experiencing nausea.

Is pregnant

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive interventions with Bluetooth Haptic Device and weighted pinprick stimuli

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

immediately after intervention

What Are the Treatments Tested in This Trial?

Interventions

• Bluetooth Haptic Device

Trial Overview The study tests if a Bluetooth haptic device can distract from pain caused by pinprick stimulators. Participants will experience both an experimental frequency and a control frequency in different sessions.

How Is the Trial Designed?

Group I: Bluetooth Haptic Device (Experimental Frequency) + Needle Sham Experimental Treatment 1 Intervention

Bluetooth Haptic Device with experimental vibrating frequency will be placed on the arm of the participant, with weighted pinpricks with fixed stimulus intensities will be applied.

Group II: Bluetooth Haptic Device (Control Frequency) + Needle Sham Placebo Group 1 Intervention

Bluetooth Haptic Device with control vibrating frequency will be placed on the arm of the participant, with weighted pinpricks with fixed stimulus intensities will be applied.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Published Research Related to This Trial

A systematic review of 14 high-quality randomized controlled trials found that digital health technologies significantly improve the management of chronic pain, particularly by enhancing patients' pain coping skills.

The studies also highlighted that these digital interventions lead to increased adherence to exercise, which is crucial for effective chronic pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital technologies in management of chronic pain - a systematic review. Hussain, A., Haroon, H., Ahmed, A., et al.[2022]

Chronic pain affects many people and comes with high costs, but access to effective behavioral interventions is limited due to barriers like a shortage of trained clinicians and inadequate insurance coverage.

Recent technological advancements present new opportunities to improve access to evidence-based pain education and treatments for both children and adults, potentially overcoming existing challenges in the healthcare system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Innovative treatment formats, technologies, and clinician trainings that improve access to behavioral pain treatment for youth and adults. Darnall, BD., Edwards, KA., Courtney, RE., et al.[2023]

The Haptigami is a novel 3-DoF fingertip haptic device that provides both vibrotactile and cutaneous force feedback, making it suitable for applications in virtual reality and rehabilitation.

Weighing only 13 g and measuring 36 x 25 x 26 mm, the Haptigami can generate significant force outputs (678 mN in compression and up to 400 mN in shear), showcasing its mechanical performance and potential for lightweight wearable technology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Haptigami: A Fingertip Haptic Interface With Vibrotactile and 3-DoF Cutaneous Force Feedback. Giraud, FH., Joshi, S., Paik, J.[2022]

A novel pressure-based tangible user interface (TUI) was developed to help individuals self-report pain intensity, showing reliable usability in studies with 28 participants who could effectively map squeeze pressure to pain levels.

The redesigned wearable version of the device, tested with 7 elderly participants, received positive feedback for its discreetness and usability, indicating strong potential for supporting chronic pain self-management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Keppi: A Tangible User Interface for Self-Reporting Pain. Adams, AT., Adams, P., Murnane, EL., et al.[2023]

The introduction of an exoskeleton-assisted hand rehabilitation system that incorporates fingertip cutaneous haptic stimulation significantly enhances user engagement during rehabilitation exercises, as shown by increased attention levels in participants.

The lightweight haptic actuators developed using soft material 3D printing techniques provide consistent and stable performance, suggesting that this innovative approach could lead to more effective rehabilitation outcomes for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Attention Enhancement for Exoskeleton-Assisted Hand Rehabilitation Using Fingertip Haptic Stimulation. Li, M., Chen, J., He, G., et al.[2021]

The study introduces a novel 3-DoF wearable haptic interface that applies force vectors directly to the fingertip, enhancing the richness of tactile feedback beyond traditional vibrotactile stimulation.

Validation through a curvature discrimination experiment showed that using this wearable device in conjunction with a standard haptic interface significantly improved performance, demonstrating its efficacy in enhancing tactile perception.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Towards wearability in fingertip haptics: a 3-DoF wearable device for cutaneous force feedback. Prattichizzo, D., Chinello, F., Pacchierotti, C., et al.[2014]

A new textile-electrode system for self-administered Phantom Motor Execution (PME) treatment showed promising results in reducing Phantom Limb Pain (PLP) for one patient, highlighting its potential efficacy for home use.

The patient reported not only reduced pain but also increased mobility and improved mental health, suggesting that factors like motivation and usability are important for the success of home-based treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Towards Implementation of a Home-Based Phantom Limb Pain Treatment Facilitated by Textile-Electrode System - A Case Study. Björkquist, A., Guo, L., Kristoffersen, MB., et al.[2023]

The Pain Tech Landscape (PTL) model was developed to align pain care needs with technological solutions, highlighting areas where technology can improve chronic pain management.

Current research primarily focuses on user-driven self-care applications, while areas like artificial intelligence and collaborative tools for pain management remain underdeveloped, suggesting opportunities for future innovation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mapping the Design Space of Technology-Based Solutions for Better Chronic Pain Care: Introducing the Pain Tech Landscape. Janevic, MR., Murnane, E., Fillingim, RB., et al.[2023]

The novel 3RRS wearable fingertip device effectively conveys stiffness information, achieving a just noticeable difference (JND) for stiffness of 208.5 ± 17.2 N/m, indicating its potential for precise tactile feedback.

In immersive virtual reality scenarios, users preferred interactions enhanced by the device's cutaneous feedback, although some found it slightly challenging to use, suggesting room for improvement in wearability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Three Revolute-Revolute-Spherical Wearable Fingertip Cutaneous Device for Stiffness Rendering. Chinello, F., Pacchierotti, C., Malvezzi, M., et al.[2018]

Wearable haptic devices have been shown to improve function in individuals with various sensory impairments, including those who are amputees, blind, or deaf, by providing sensory replacement or augmentation during rehabilitation.

Future development of these devices should prioritize clinical needs and focus on creating intuitive, energy-efficient, and biomechanically compliant designs for long-term use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Haptic wearables as sensory replacement, sensory augmentation and trainer - a review. Shull, PB., Damian, DD.[2019]

Citations

1. withpower.com withpower.com/trial/phase-pain-5-2024-bd649

Bluetooth Haptic Device for Pain · Info for Participants What data supports the effectiveness of the Bluetooth Haptic Device treatment for pain? The research highlights the potential of digital technologies to improve ...

2. nature.com nature.com/articles/s41598-024-53261-3

A novel theta-controlled vibrotactile brain–computer ... Patients increased their BCI performance, reflecting thought-driven control of neurofeedback, and showed a significant decrease in pain severity ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0956566324004378

Biosymbiotic haptic feedback - Sustained long term human ... These capabilities enable haptic feedback for robotic surgery training and posture correction over weeks of use with neural net computation.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8587551/

Low Back Pain—Behavior Correction by Providing Haptic ... This paper proposes a wearable device to monitor the back posture of the user and provide feedback when the participant is performing a possible hurtful ...

5. clinicaltrial.be clinicaltrial.be/en/details/451418?per_page=100&only_recruiting=0&only_eligible=0

Examining Bluetooth Haptic Device Use for Pain and Anxiet... This pragmatic, randomized study seeks to evaluate the applications of a novel vibrating device for reducing pediatric anxiety and distress during vascular ...

6. withpower.com withpower.com/trial/phase-anxiety-disorders-5-2024-415b6

Bluetooth Haptic Device for Reducing Anxiety and Pain The Bluetooth Haptic Device is unique because it uses vibrations to interact with the skin, providing a tactile (touch-based) experience to reduce anxiety ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06271642

Impact of Vibrating Device Distraction on Mechanical Pain ... Bluetooth Haptic Device with control vibrating frequency will be placed on the arm of the participant, with weighted pinpricks with fixed stimulus intensities ...

8. mdpi.com mdpi.com/2076-3417/10/24/8827

A Haptic Feedback Actuator Suitable for the Soft Wearable ... The actuator is very flexible and safe, and it is a good fit for wearable devices owing to its well-designed structure and advanced preparation ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11672320/

Cutaneous Electrohydraulic (CUTE) Wearable Devices for ... This article presents a system architecture for compact wearable devices that deliver salient and pleasant broad‐bandwidth haptic cues.