Impact of Bluetooth Haptics Device Distraction on Mechanical Pain Thresholds Induced by PinPrick Stimulators

Pain Clinical Trial

Official title:

Impact of Bluetooth Haptics Device Distraction on Mechanical Pain Thresholds Induced by PinPrick Stimulators

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06271642
• Other study ID #: 73822
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: May 31, 2025

Study information

• Verified date: February 2024
• Source: Stanford University
• Contact: Samuel Rodriguez, MD
• Phone: 650-723-5728
• Email: sr1[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: May 31, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Greater than 18 years of age
• English speaking
• Hearing intact

Exclusion Criteria:

• History of chronic pain or acute pain syndromes
• Currently has nausea
• Has hearing loss
• Is pregnant
• Is currently taking beta blockers, chronotropic heart medications, or opioids or other prescription pain medications

Related Conditions & MeSH terms

• Anxiety
• Pain

Intervention

Behavioral:
• Bluetooth Haptic Device (Experimental Frequency) + Needle Sham only
Participants will have the Bluetooth Haptic Device with experimental Frequency placed on their arm and randomized to a series of 4 different vibration patterns/frequencies. Mechanical pain threshold (MPT) will be measure using custom-made weighted pinprick stimuli as a set of five pinprick mechanical stimulators with fixed stimulus intensities (flat contact area of 0.2mm diameter) with forces of 32, 64, 128, 256, and 512mN. The stimulators will be applied at a rate of 2s on, 2s off in a randomized order on participants' forearms until the first sensation of pain is reached and will then be done in descending order until the sensation of pain disappears. This procedure will be repeated five times of ascending and descending stimuli served as pinprick pain threshold on 1 arm at 4 different frequencies/patterns in the BHD.
• Bluetooth Haptic Device (Control Frequency) + Needle Sham only
Participants will have the Bluetooth Haptic Device with control frequency placed on their arm. They will be randomized to a series of 4 different vibration patterns/frequencies. Mechanical pain threshold (MPT) will be measure using custom-made weighted pinprick stimuli as a set of five pinprick mechanical stimulators with fixed stimulus intensities (flat contact area of 0.2mm diameter) with forces of 32, 64, 128, 256, and 512mN. The stimulators will be applied at a rate of 2s on, 2s off in a randomized order on participants' forearms until the first sensation of pain is reached and will then be done in descending order until the sensation of pain disappears. This procedure will be repeated five times of ascending and descending stimuli served as pinprick pain threshold on 1 arm at 4 different frequencies/patterns in the BHD.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mechanical Pain Threshold	Mechanical Pain Threshold will be measured using custom-made weighted pinprick stimuli as a set of seven pinprick mechanical stimulators with fixed stimulus intensities (flat contact area of 0.2mm diameter) with forces of 8, 16, 32, 64, 128, 256, and 512mN.	immediately after intervention
Secondary	Mechanical pain sensitivity	Mechanical pain sensitivity will be taken immediately following each group of levels tests from 0-10; 0=no pain to 10=worst pain ever experienced.	immediately after intervention
Secondary	Anxiety scores	Anxiety level measured by a numerical rating scale (NRS) from 0-10. Scale ranges from 0-10, with higher scores indicating higher anxiety levels.	immediately after intervention