Efficacy of the Quell Wearable Device for Chronic Overlapping Pain Conditions

Last updated: February 28, 2025
Sponsor: Brigham and Women's Hospital
Overall Status: Completed

Phase

N/A

Condition

Chronic Pain

Allergy (Pediatric)

Allergy

Treatment

High Intensity Quell

Low Intensity Quell

Clinical Study ID

NCT05540002
2022P002083
  • Ages 21-99
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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

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, psychoticdisorder, or dissociative disorder that would be judged to interfere with studyparticipation

  • 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 wouldinterfere with study participation

  • Have an implanted cardiac pacemaker, defibrillator, or other implanted device.

  • Reynaud's syndrome

  • Open cuts/sores

Study Design

Total Participants: 115
Treatment Group(s): 2
Primary Treatment: High Intensity Quell
Phase:
Study Start date:
October 14, 2022
Estimated Completion Date:
September 19, 2024

Study Description

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. Participants will attend two quantitative sensory testing visits in order to determine their level of pain sensitivity, one at the beginning of the study and the second at the 3-month Follow-up session. Participants will be asked to test out the Quell device to check for sensation tolerance, and will then be randomized into one of the two treatment groups: the High Intensity Quell group or the Low Intensity Quell group. Participants will be asked to wear the device for at least 3 hours every day and to complete daily assessments, along with a total of three sets of questionnaires: one at the start of the study, the second 6 weeks from the date of consent, and the third 3 months after the date of consent. A member of the research staff will call participants once a week for a brief phone interview throughout the study. Participants will be in this study for 3 months.

Connect with a study center

  • Brigham and Women's Hospital Pain Management Center

    Chestnut Hill, Massachusetts 02467
    United States

    Site Not Available

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