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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
Must not have
Acute osteomyelitis or acute bone disease
Diagnosis of cancer or any other malignant disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3-month follow-up
Awards & highlights
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.
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.
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 belowSelect...
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a recent bone infection or disease.
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I have been diagnosed with cancer or another type of malignant disease.
Select...
I need urgent surgery for my pain condition.
Select...
I have open cuts or sores.
Select...
I have Reynaud's syndrome.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3-month follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3-month follow-up
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
The Brief Pain Inventory Interference Scale (BPI)
Secondary study objectives
Healthcare Utilization
Hospital Anxiety and Depression Scale (HADS)
MasterMyPain App
+8 moreTrial 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.
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Who is running the clinical trial?
NeuroMetrix, Inc.Industry Sponsor
6 Previous Clinical Trials
315 Total Patients Enrolled
1 Trials studying Chronic Pain
30 Patients Enrolled for Chronic Pain
Brigham and Women's HospitalLead Sponsor
1,653 Previous Clinical Trials
11,490,920 Total Patients Enrolled
20 Trials studying Chronic Pain
1,932 Patients Enrolled for Chronic Pain
Robert N. Jamison, Ph.D.Principal InvestigatorBrigham and Women's Hospital
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any severe illnesses that could affect my treatment.You have been found to be very sensitive to touch, heat, or cold based on testing.I have been diagnosed with cancer or another type of malignant disease.I have been diagnosed with several chronic pain conditions.I need urgent surgery for my pain condition.My pain has lasted for more than 3 months.I have chronic pain from conditions like headaches, joint, or back pain.You have been diagnosed with schizophrenia, delusional disorder, or other severe mental health conditions that may affect your ability to take part in the study.I am 21 years old or older.My average pain level is 4 or more on a scale of 0 to 10.I have a recent bone infection or disease.You are currently addicted to drugs like cocaine or heroin, and this could affect your ability to take part in the study.I own a smartphone and can download the required apps.I have open cuts or sores.My pain is not caused by any other worsening disease.I have Reynaud's syndrome.
Research Study Groups:
This trial has the following groups:- Group 1: Low Intensity Stimulation
- Group 2: High Intensity Stimulation
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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