Efficacy of the Quell Wearable Device for Fibromyalgia

NCT03714425 | Completed Results FDA Device

• 1 other identifier: 2018P002392
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (1)

• Patients' Global Impression of Change

  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.

  3 months

Secondary Outcomes (6)

• The Brief Pain Inventory

  Baseline, 3 months

• Revised Fibromyalgia Impact Questionnaire

  Baseline, 3 months

• Pain Catastrophizing Scale

  Baseline, 3 months

• Pain Disability Index

  Baseline, 3 months

• Hospital Anxiety and Depression Scale

  Baseline, 3 months

Study Arms (2)

High frequency device

ACTIVE COMPARATOR

Subjects will use high frequency Quell devices.

Device: Quell

Low frequency device

SHAM COMPARATOR

Subjects will use low frequency Quell devices.

Device: Quell

Interventions

Quell DEVICE

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.

High frequency device; Low frequency device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Chestnut Hill, Massachusetts, 02467, United States

Location

Related Publications (1)

• 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.

  PMID: 34335055 DERIVED

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Limitations and Caveats

There were several limitations. The study included a limited number of subjects. Subjects were only followed for 3 months. There was no in-person history or physical examination. Many chose not to tolerate the higher levels of stimulation. The subjects had other medical comorbidities. The symptom reporting was not required while the participants were using the TENS.

Results Point of Contact

• Title: Robert Jamison
• Organization: Brigham and Women's Hospital

rjamison@bwh.harvard.edu

617-732-9046

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anaesthesia, Harvard Medical School

Model Details: High frequency device vs. Low frequency device

Study Record Dates

• First Submitted: October 17, 2018
• First Posted: October 22, 2018
• Study Start: February 1, 2019
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: August 15, 2022
• Results First Posted: June 21, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)