N/A
N=119
Efficacy of the Quell Wearable Device for Fibromyalgia
Fibromyalgia
Bottom Line
View on ClinicalTrials.gov: NCT03714425 ↗Enrolled (actual)
119
Serious AEs
0.0%
Results posted
Jun 2022
Primary outcome: Primary: Patients' Global Impression of Change — 3.58; 3.24 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Quell (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Brigham and Women's Hospital
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patients' Global Impression of Change |
3.58; 3.24 | — |
| SECONDARY The Brief Pain Inventory |
5.8; 5.5 | — |
| SECONDARY Revised Fibromyalgia Impact Questionnaire |
61.3; 52.8 | — |
| SECONDARY Pain Catastrophizing Scale |
21.5; 17.8 | — |
| SECONDARY Pain Disability Index |
39.4; 34.6 | — |
| SECONDARY Hospital Anxiety and Depression Scale |
18.5; 15.8 | <0.05 sig |
| SECONDARY Helpfulness Rating |
4.8; 4.8 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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)
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03714425). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.