Efficacy of the Quell Wearable Device for Fibromyalgia
Completed · Not applicable
Conditions studied: Fibromyalgia
In brief
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.
Key facts
- Study ID
- NCT03714425
- Run by
- Brigham and Women's Hospital
- People needed
- 119
- Starts
- 2019-02-01
- Expected to finish
- 2020-12-01
- Last updated by the study team
- 2022-08-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- have chronic pain related to FM for > 3 months' duration
- average 4 or greater on a pain intensity scale of 0 to 10
- are able to speak and understand English
- have a smartphone (Android or iPhone)
You may not qualify if…
- diagnosis of cancer or any other malignant disease
- acute osteomyelitis or acute bone disease
- present or 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 (positive on the Mini International Neuropsychiatric Interview; M.I.N.I. v.5.0), that would interfere with study participation
- have an implanted cardiac pacemaker, defibrillator, or other implanted device
Where it is running
- Brigham and Women's Hospital — Chestnut Hill, Massachusetts, United States
Full record on ClinicalTrials.gov
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