Clinical trial NCT03714425: Efficacy of the Quell Wearable Device for Fibromyalgia
Official title: Efficacy of the Quell Wearable Device for Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2018-10-22
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: High frequency device vs. Low frequency device
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Patients' Global Impression of Change
timeFrame: 3 months
Secondary outcomes:
measure: The Brief Pain Inventory
timeFrame: Baseline, 3 months
measure: Revised Fibromyalgia Impact Questionnaire
timeFrame: Baseline, 3 months
measure: Pain Catastrophizing Scale
timeFrame: Baseline, 3 months
measure: Pain Disability Index
timeFrame: Baseline, 3 months
measure: Hospital Anxiety and Depression Scale
timeFrame: Baseline, 3 months
measure: Helpfulness Rating
timeFrame: Post-treatment at 3 months
Other outcomes:
Locations:
city: Chestnut Hill
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
References:
citation: Jamison RN, Edwards RR, Curran S, Wan L, Ross EL, Gilligan CJ, Gozani SN. Effects of Wearable Transcutaneous Electrical Nerve Stimulation on Fibromyalgia: A Randomized Controlled Trial. J Pain Res. 2021 Jul 24;14:2265-2282. doi: 10.2147/JPR.S316371. eCollection 2021.