Note: This study is currently only recruiting patients in the hospital.

If you are interested in being notified if this study begins recruiting from the general population, please use the 'I Am Interested' button below.

Are you suffering from fibromyalgia?

The purpose of the study is to examine the pain-relieving effects of a transcutaneous electrical nerve stimulator device call a Quell among adults with fibromyalgia.

Brigham and Women's Hospital Chronic Pain Fibromyalgia
2 visits over 3 months
Estimated Time Commitment
Male, Female, 21-years or older
May Be Eligible
Payment up to $100
May Be Offered
Survey, Office visit
May Be Required
 
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This project is not recruiting.

Overview

What we are studying

The purpose of the study is to examine the pain-relieving effects of a transcutaneous electrical nerve stimulator device call a Quell for persons with fibromyalgia. The Quell is a battery powered device with rechargeable batteries and is strapped to your upper calf with a velcro band. Patients will be assigned to one of two treatment groups by chance, like flipping a coin: (1) High Intensity group or (2) Low Intensity group. This study hopes to find out whether low intensity or high intensity stimulation is most useful among persons with fibromyalgia.


Why it is important


What we hope to accomplish

Principal Investigator

Robert N. Jamison, PhD

Brigham and Women's Hospital

Public Profile

Who can participate


  1. Adults 21 or older

  2. Diagnosed with fibromyalgia for > 3 months

  3. Pain score greater than 4 on average (0-10 scale)

  4. Able to speak and understand English

  5. Own a smart phone (iPhone/Android) and have Quell Relief app on the phone


 

Who cannot participate

(1) diagnosis of cancer or any other malignant disease


(2) acute osteomyelitis or acute bone disease


(3) present or past 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 that would interfere with study participation


(8) have an implanted cardiac pacemaker, defibrillator, or other implanted device

What you may be asked to do

It will take you about 3 months to complete this research study. However, you will only need to meet with the research assistant twice. You will be assigned to either use a High Intensity Quell stimulator or Low Intensity Quell stimulator by chance, like flipping a coin. We will ask that you wear it for at least 2 hours every day. Over the course of the 3 months, you will be asked to complete a total of three packets of questionnaires and we will administer weekly phone interviews throughout the study.


 


Project activities may include:

  • Survey
  • Office visit

Estimated Time Commitment

2 visits over 3 months

What You May Get

Payment and Quell device

Location

Brigham and Women's Hospital-Pain Management Center
850 Boylston St, Suite 320, Chestnut Hill MA 02467

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Travel

  • Parking available
  • Accessible by public transportation

Travel and Parking Details

Additional Information

ClinicalTrials.gov Identifier

NCT03714425


Participating Institutions


Funding Source

  • Industry
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