100 Participants Needed

NOICE Device for Pain

MS
TC
Overseen ByThomas Caruso, MD, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Stanford University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

Yes, you will need to stop taking any pain medications to participate in this trial.

What data supports the effectiveness of the NOICE device treatment for pain?

The NOICE device may be similar to the Nociception Level (NOL) index, which has been explored for assessing pain in various settings, such as postoperative care and chronic pain management. Studies have shown that multi-parameter technologies like the NOL index can help evaluate pain by monitoring physiological changes, suggesting potential effectiveness in pain assessment and management.12345

Is the NOICE Device generally safe for humans?

The available research highlights that adverse event (AE) reporting in nonpharmacologic pain treatments, like the NOICE Device, is often inadequate, meaning safety data might be incomplete or inconsistent. However, trials involving patients tend to report more detailed AE information than those with healthy volunteers.678910

How is the NOICE device treatment different from other pain treatments?

The NOICE device is unique because it likely uses a combination of mechanical stimulation, such as vibration, to reduce pain, which is different from traditional pain treatments that often rely on medications. This approach can provide pain relief without the side effects associated with drugs.1112131415

What is the purpose of this trial?

This is a prospective, randomized, crossover study on healthy volunteers evaluating the impact of spatial audio on heat pain threshold (HPT). The primary center for this study will be Lucile Packard Children's Hospital (Stanford University, Palo Alto, CA) and other Stanford affiliated sites.

Eligibility Criteria

This trial is for healthy volunteers interested in how spatial audio affects heat pain threshold. Specific eligibility criteria are not provided, but typically participants should be free from conditions that could interfere with the study.

Inclusion Criteria

My hearing is normal.
I speak English.

Exclusion Criteria

I am taking pain medication.
I am experiencing hearing loss.
I am taking medication that affects my heart rate.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo a crossover study to evaluate the impact of spatial audio on heat pain threshold using the NOICE device

15 minutes per session
2 sessions (in-person)

Follow-up

Participants are monitored for device satisfaction, anxiety levels, and system usability immediately after each intervention

immediately after intervention

Treatment Details

Interventions

  • NOICE device
Trial Overview The NOICE device's effectiveness on pain and anxiety is being tested. Participants will try the device with and without distraction to see if it changes their heat pain threshold. The study design allows each person to experience both scenarios.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: without NOICE then NOICE DeviceExperimental Treatment2 Interventions
Participant will conduct the experiment without using NOICE device first and then with NOICE device
Group II: NOICE Device then without NOICE deviceExperimental Treatment2 Interventions
Participant will conduct the experiment using NOICE device first and then without NOICE device

Find a Clinic Near You

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials
2,527
Recruited
17,430,000+

Findings from Research

A systematic review of nonpharmacologic pain treatment trials revealed significant inadequacies in adverse event (AE) reporting, with less than half of the trials detailing specific AE assessment methods.
AE reporting was more comprehensive in trials involving patients compared to those with healthy volunteers, indicating a need for improved adherence to reporting guidelines across all types of trials.
Adverse event reporting in nonpharmacologic, noninterventional pain clinical trials: ACTTION systematic review.Hunsinger, M., Smith, SM., Rothstein, D., et al.[2018]
A systematic review of 80 randomized controlled trials (RCTs) on noninvasive analgesic treatments revealed that adverse event (AE) reporting was often incomplete, with over 40% of trials not reporting any serious adverse events.
The review highlighted that trials involving participants with pain conditions and those sponsored by industry provided better AE data, indicating a need for improved consistency and thoroughness in AE reporting across all analgesic RCTs.
Adverse event assessment, analysis, and reporting in recent published analgesic clinical trials: ACTTION systematic review and recommendations.Smith, SM., Wang, AT., Katz, NP., et al.[2023]
In a study of Medicare beneficiaries averaging 80 years old, opioids were found to have a significantly higher risk of cardiovascular events and all-cause mortality compared to nonselective NSAIDs (nsNSAIDs).
Coxibs showed a reduced risk of gastrointestinal bleeding compared to nsNSAIDs, but both coxibs and nsNSAIDs had similar fracture risks, while opioids were associated with a much higher fracture risk.
The comparative safety of analgesics in older adults with arthritis.Solomon, DH., Rassen, JA., Glynn, RJ., et al.[2022]

References

Nociception level index variations in patients with complex regional pain syndrome: a pilot study. [2023]
Assessing individual outcomes during outpatient multidisciplinary chronic pain treatment by means of an augmented SF-36. [2004]
Exploration of a Multi-Parameter Technology for Pain Assessment in Postoperative Patients After Cardiac Surgery in the Intensive Care Unit: The Nociception Level Index (NOL)TM. [2022]
Analgesia Nociception Index Monitoring in the Evaluation of Postoperative Pain in Children: A Prospective Observational Pilot Study. [2023]
Acute pain therapy in postanesthesia care unit directed by skin conductance: a randomized controlled trial. [2022]
Adverse event reporting in nonpharmacologic, noninterventional pain clinical trials: ACTTION systematic review. [2018]
Adverse Events and Nocebo Effects in Inflammatory Bowel Disease: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. [2021]
Adverse event assessment, analysis, and reporting in recent published analgesic clinical trials: ACTTION systematic review and recommendations. [2023]
The comparative safety of analgesics in older adults with arthritis. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Adverse Event Reporting in Clinical Trials of Intravenous and Invasive Pain Treatments: An ACTTION Systematic Review. [2018]
Quantitative pinch stimulator for exploring evoked nociceptive responses: a pilot study. [2021]
Clinical pain evaluation with intraoral vibration device during local anesthetic injections. [2022]
13.United Statespubmed.ncbi.nlm.nih.gov
The efficacy of 95-Hz topical vibration in pain reduction for trigger finger injection: a placebo-controlled, prospective, randomized trial. [2021]
[Reduction of pain during intravenous cannulation in children: Buzzy application]. [2021]
Vibratory stimulation increase the electro-cutaneous sensory detection and pain thresholds in women but not in men. [2018]
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