Efficacy of the Quell Wearable Device for Chronic Low Back Pain
CompletedNot applicableNCT02944513
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
This is a 1-year trial designed to gather information about the use of the Quell for persons with chronic musculoskeletal low back pain.
Study details
- Official title
- Efficacy of the Quell Wearable Device for Chronic Low Back Pain
- Conditions
- Interventions
- Device: Quell
- Sponsor
- Brigham and Women's Hospital
- Start date
- 2016-10
- Primary completion
- 2018-08
- Sex
- All
- Age range
- from 21 Years to 99 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Total sites listed
- 0
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * All participants will be adults age 21 or older and diagnosed with axial musculoskeletal back pain without radiculopathy. * Patients will be invited to participate if they own a smart phone (iPhone or Android device) and are able to download the pain app and the Quell Relief program app onto their device. * Patients will also be included if they: 1. have chronic pain 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. Exclusion Criteria: * Patients will be excluded from participation if they meet any of the following criteria: 1. diagnosis of cancer or any other malignant disease 2. acute osteomyelitis or acute bone disease 3. present or past Diagnostic and Statistical Manual-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. any prescription opioid use for pain 9. have an implanted cardiac pacemaker, defibrillator, or other implanted device. All subjects will be asked to not change their treatment during the study period.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02944513