Efficacy of the Quell Wearable Device for Chronic Overlapping Pain Conditions
CompletedNot applicableNCT05540002
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
This study will examine the pain-relieving effects of a transcutaneous electrical nerve stimulator device called a Quell for persons with multiple chronic overlapping pain conditions.
Study details
- Official title
- Efficacy of the Quell Wearable Device for Treatment of Central Sensitization-related Pain Among Persons With Chronic Overlapping Pain Conditions
- Conditions
- Chronic Pain
- Adults 21 and Older
- Multiple Chronic Overlapping Pain Conditions
- Hypersensitivity
- Interventions
- Device: High Intensity Quell
- Device: Low Intensity Quell
- Sponsor
- Brigham and Women's Hospital
- Collaborators
- NeuroMetrix, Inc.
- Start date
- 2022-10-14
- Primary completion
- 2024-09-19
- Sex
- All
- Age range
- from 21 Years to 99 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Ages 21 and older * Pain duration \> 3 months * Diagnosed by physician with multiple chronic pain conditions * Have chronic pain related to multiple chronic pain diagnoses (headaches, joint pain, back pain, or any of the other COPCs) * Average 4 or greater on pain intensity scale of 0 to 10 * Pain is not accounted for by any other progressive disease (e.g., cancer, MS) * Meets sensory hypersensitivity cutoffs based on QST-assessed evidence * Own a smartphone (iPhone or Android device) and can download the pain app (MasterMyPain) and the Quell Relief mobile app onto their device * Able to speak and understand English Exclusion Criteria: * Diagnosis of cancer or any other malignant disease * Acute osteomyelitis or acute bone disease * Present of past DSM-V diagnosis of schizophrenia, delusional disorder, psychotic disorder, or dissociative disorder that would be judged to interfere with study participation * Pregnancy * Any clinically unstable systemic illness judged to interfere with treatment * A pain condition requiring urgent surgery * An active substance use disorder, such as cocaine or IV heroin use that would interfere with study participation * Have an implanted cardiac pacemaker, defibrillator, or other implanted device. * Reynaud's syndrome * Open cuts/sores
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05540002