Efficacy of the Quell Wearable Device for Chronic Overlapping Pain Conditions

Mass General Brigham

Status: Completed

Conditions: Chronic Pain; Hypersensitivity; Multiple Chronic Overlapping Pain Conditions; Adults 21 and Older

Treatments: Device: Low Intensity Quell; Device: High Intensity Quell

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05540002

2022P002083

Details and patient eligibility

About

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.

Full 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.

Enrollment: 115 patients

Sex: All

Ages: 21 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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115 participants in 2 patient groups

High Intensity Stimulation

Active Comparator group

Description:

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

Treatment:

Device: High Intensity Quell

Low Intensity Stimulation

Sham Comparator group

Description:

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

Treatment:

Device: Low Intensity Quell