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NCT03714425 · ClinicalTrials.gov registry record · NA
Efficacy of the Quell Wearable Device for Fibromyalgia
A NA study, sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- NA
- Development phase
- 119
- Enrollment target
NCT03714425: Completed NA study, sponsored by Brigham and Women's Hospital.
NCT03714425 is a NA study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 119 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03714425, a NA study, has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 119 participants
- Enrollment target
Study 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.
Primary Outcome
The questionnaire reflects a patient's belief about the efficacy of treatment. The Patients' Global Impression of Change (PGIC) is a 7-point scale (1-7) depicting a patient's rating of overall improvement. Patients rate their change as 1="very much improved," 2="much improved," 3="minimally improved," 4="no change," 5="minimally worse," 6="much worse," or 7="very much worse." Lower values represent a better outcome.
Interventions
- DEVICE Quell
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 119 participants |
| Start Date | 2019-02-01 |
| Est. Completion | 2020-12-01 |
| Phase | NA |
What the finished NCT03714425 record still lists
NCT03714425 is an interventional study that assigns participants to a tested intervention. The registered 119 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 1 intervention - of which Quell is the first listed.
NCT03714425 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03714425 about?
NCT03714425 is a clinical study titled "Efficacy of the Quell Wearable Device for Fibromyalgia". 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 devic...
What is the current status of trial NCT03714425?
This trial is currently completed. It is a NA study. The enrollment target is 119 participants. The study started on 2019-02-01. Estimated completion is 2020-12-01.
What interventions are being tested in trial NCT03714425?
The interventions under investigation include: Quell (DEVICE).
Who is sponsoring clinical trial NCT03714425?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03714425's enrollment target sits among peer trials
119 803rd of 2000 higher than 1,198 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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