Efficacy of the Quell Wearable Device for Fibromyalgia

Mass General Brigham

Status: Completed

Conditions: Fibromyalgia

Treatments: Device: Quell

Study type: Interventional

Funder types: Other

Identifiers

NCT03714425

2018P002392

Details and patient eligibility

About

This study is designed for patients with primary fibromyalgia (FM) pain. The overall aim of the study is to determine the effect of the high frequency Quell device to manage FM compared with a low frequency device. Investigators hypothesize that those assigned to using the high frequency Quell device will report reduced pain compared with those using the low frequency Quell device; with those using the high frequency device also showing more improvement in sleep, mood, and level of activity. Investigators also hypothesize that frequency of using the Quell (increased tolerability and adherence) will be correlated with greater reduction in pain.

Full description

The Quell is battery powered with rechargeable batteries and is strapped to participant's upper calf with a velcro band. It has been cleared by the FDA for safety. It is designed to improve fibromyalgia by the principles of transcutaneous electrical stimulation of nerves much like a traditional transcutaneous electrical nerve stimulator (TENS) unit. Investigators expect to enroll approximately 130 subjects in this study. Participants will be equally randomized to one of two experimental groups: High Frequency Quell group (N=65) or Low Frequency Quell group (N=65). This study hopes to find out whether low frequency or high frequency stimulation is most useful among persons with fibromyalgia.

Enrollment: 119 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. have chronic pain related to FM for > 3 months' duration
2. average 4 or greater on a pain intensity scale of 0 to 10
3. are able to speak and understand English
4. have a smartphone (Android or iPhone)

Exclusion criteria

1. diagnosis of cancer or any other malignant disease
2. acute osteomyelitis or acute bone disease
3. present or past DSM-V diagnosis of schizophrenia, delusional disorder, psychotic disorder, or dissociative disorder that would be judged to interfere with study participation
4. pregnancy
5. any clinically unstable systemic illness judged to interfere with treatment
6. a pain condition requiring urgent surgery
7. an active substance use disorder, such as cocaine or IV heroin use (positive on the Mini International Neuropsychiatric Interview; M.I.N.I. v.5.0), that would interfere with study participation
8. have an implanted cardiac pacemaker, defibrillator, or other implanted device

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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119 participants in 2 patient groups

High frequency device

Active Comparator group

Description:

Subjects will use high frequency Quell devices.

Treatment:

Device: Quell

Low frequency device

Sham Comparator group

Description:

Subjects will use low frequency Quell devices.

Treatment:

Device: Quell