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

120 Participants Needed

Trial Summary

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 data supports the effectiveness of the Bluetooth Haptic Device treatment for pain?

The research highlights the potential of digital technologies to improve access to pain management, suggesting that innovative devices like the Bluetooth Haptic Device could be effective in managing chronic pain by increasing accessibility to treatment. Additionally, wearable devices for pain self-assessment have shown high receptivity among users, indicating that similar haptic devices might be well-received and beneficial for pain management. ^{1 2 3 4 5}

How does the Bluetooth Haptic Device for Pain differ from other treatments for pain?

The Bluetooth Haptic Device for Pain is unique because it uses a wearable fingertip haptic device to provide somatosensory feedback, which can enhance rehabilitation and control interfaces. Unlike traditional pain treatments, this device offers a novel approach by delivering vibrotactile and cutaneous force feedback, potentially improving user engagement and effectiveness in pain management. ^{6 7 8 9 10}

What is the purpose of this trial?

This is a prospective, crossover study of healthy participants evaluating the mechanical pain threshold for weighted pinprick stimuli.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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 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 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]

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]

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Innovative treatment formats, technologies, and clinician trainings that improve access to behavioral pain treatment for youth and adults. [2023]

2. Pakistan pubmed.ncbi.nlm.nih.gov

Digital technologies in management of chronic pain - a systematic review. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Keppi: A Tangible User Interface for Self-Reporting Pain. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Mapping the Design Space of Technology-Based Solutions for Better Chronic Pain Care: Introducing the Pain Tech Landscape. [2023]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Towards Implementation of a Home-Based Phantom Limb Pain Treatment Facilitated by Textile-Electrode System - A Case Study. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Attention Enhancement for Exoskeleton-Assisted Hand Rehabilitation Using Fingertip Haptic Stimulation. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Haptigami: A Fingertip Haptic Interface With Vibrotactile and 3-DoF Cutaneous Force Feedback. [2022]

8. England pubmed.ncbi.nlm.nih.gov

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

9. United States pubmed.ncbi.nlm.nih.gov

A Three Revolute-Revolute-Spherical Wearable Fingertip Cutaneous Device for Stiffness Rendering. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Towards wearability in fingertip haptics: a 3-DoF wearable device for cutaneous force feedback. [2014]