CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 119 enrolled
Drug / intervention
Quelldevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03714425
NCT03714425N/ACompleted
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Efficacy of the Quell Wearable Device for Fibromyalgia

Brigham and Women's Hospital·interventional·Posted Oct 22, 2018·Updated Aug 15, 2022

In Brief

A clinical study evaluating Quell for Fibromyalgia. Completed, enrolled 119 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFibromyalgia
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedOct 22, 2018
Enrollment StartFeb 1, 2019
Primary CompletionDec 1, 2020
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 7.7 years ago

Interventions

Quelldevice

Quell is a Transcutaneous Electrical Nerve Stimulator Device (TENS). The device will use nerve stimulation to treat chronic pain by sending signals to the brain that cause it to release natural opioids.