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Transcutaneous Electrical Nerve Stimulator

Quell Wearable Device for Chronic Pain

N/A

Recruiting

Led By Robert N. Jamison, Ph.D.

Research Sponsored by Brigham and Women's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ages 21 and older

Average 4 or greater on pain intensity scale of 0 to 10

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3-month follow-up

Awards & highlights

Study Summary

This trial will test the effectiveness of a device called a Quell for people with multiple chronic pain conditions.

Who is the study for?

This trial is for adults over 21 with chronic pain from multiple conditions like headaches, joint or back pain. Participants need a smartphone to use specific apps and must understand English. They should have ongoing pain not due to progressive diseases like cancer or MS, rate their pain 4+ on a scale of 0-10, and meet certain sensitivity criteria.Check my eligibility

What is being tested?

The study tests the Quell device's effectiveness in relieving chronic pain through electrical nerve stimulation. It compares two intensities: high and low. Participants will use the device alongside mobile apps that track their experience.See study design

What are the potential side effects?

Potential side effects may include skin irritation where the device is worn, discomfort from electrical stimulation, muscle twitching, or an increase in pain if settings are not properly adjusted.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 21 years old or older.

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My average pain level is 4 or more on a scale of 0 to 10.

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I have been diagnosed with several chronic pain conditions.

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My pain has lasted for more than 3 months.

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My pain is not caused by any other worsening disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3-month follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3-month follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-month follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The Brief Pain Inventory Interference Scale (BPI)

Secondary outcome measures

Healthcare Utilization

Hospital Anxiety and Depression Scale (HADS)

MasterMyPain App

+8 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: High Intensity StimulationActive Control1 Intervention

Patients will be randomly assigned to the High Intensity Quell group and will receive higher intensity stimulation every day for 12 weeks.

Group II: Low Intensity StimulationPlacebo Group1 Intervention

Patients will be randomly assigned to the Low intensity Quell group and will receive lower intensity stimulation every day for 12 weeks.

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

NeuroMetrix, Inc.Industry Sponsor

6 Previous Clinical Trials

325 Total Patients Enrolled

Brigham and Women's HospitalLead Sponsor

1,615 Previous Clinical Trials

11,470,715 Total Patients Enrolled

19 Trials studying Chronic Pain

1,666 Patients Enrolled for Chronic Pain

Robert N. Jamison, Ph.D.Principal InvestigatorBrigham and Women's Hospital

Media Library

Quell Wearable Device (Transcutaneous Electrical Nerve Stimulator) Clinical Trial Eligibility Overview. Trial Name: NCT05540002 — N/A

Chronic Pain Research Study Groups: Low Intensity Stimulation, High Intensity Stimulation

Chronic Pain Clinical Trial 2023: Quell Wearable Device Highlights & Side Effects. Trial Name: NCT05540002 — N/A

Quell Wearable Device (Transcutaneous Electrical Nerve Stimulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05540002 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are permitted to participate in this experiment?

"Affirmative. According to clinicaltrials.gov, this study is currently recruiting participants who meet the criteria established on October 14th 2022 and modified as recently as November 10th 2022. 115 individuals are needed from a single research centre."

Answered by AI

Do I fulfill the criteria to be part of this research endeavor?

"This research project is recruiting 115 adults (21 years and older) with hypersensitivity. The key requirements for enrolment include: chronic pain related to multiple diagnoses, a score of four or more on the 0-10 pain intensity scale, possession of an iPhone/Android device and compatible applications, inability to attribute symptoms to any other progressing illness, meeting sensory hypersensitivity cutoffs based on QST assessment results, and speaking English fluently."

Answered by AI

Can adults over the age of 45 partake in this investigation?

"According to the requirements for enrolment, prospective participants must be between 21 and 99 years old. For those younger than 18 or over 65 there are 358 and 1127 trials respectively available."

Answered by AI

Is enrollment for this research experiment still available?

"This trial, which was initially posted on October 14th 2022 and recently updated on November 10th 2022, is currently recruiting potential participants."

Answered by AI

Who else is applying?

What state do they live in?

South Dakota

What site did they apply to?

Brigham and Women's Hospital Pain Management Center

What portion of applicants met pre-screening criteria?

Met criteria

How many prior treatments have patients received?

Why did patients apply to this trial?

I've tried over 3 plus drugs over the past 20 years and they would work for a while then stop. Sometimes I would have side effects that would cause me to stop taking it. Also I would get the affect of drowsiness and inability to wake up at a decent time.

PatientReceived no prior treatments

Recent research and studies

clinicaltrials.govStudy

Efficacy of the Quell Wearable Device for Chronic Overlapping Pain Conditions

Robert N. Jamison, PhD 2022. "Efficacy of the Quell Wearable Device for Chronic Overlapping Pain Conditions". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05540002.

All > Complex Regional Pain Syndrome > Allergy