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Efficacy of the Quell Wearable Device for Chronic Low Back Pain

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ClinicalTrials.gov Identifier: NCT02944513
Recruitment Status : Completed
First Posted : October 26, 2016
Results First Posted : February 26, 2019
Last Update Posted : April 25, 2022
Information provided by (Responsible Party):
Robert N. Jamison, PhD, Brigham and Women's Hospital

Tracking Information
First Submitted Date  ICMJE October 24, 2016
First Posted Date  ICMJE October 26, 2016
Results First Submitted Date  ICMJE January 15, 2019
Results First Posted Date  ICMJE February 26, 2019
Last Update Posted Date April 25, 2022
Actual Study Start Date  ICMJE October 2016
Actual Primary Completion Date August 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 26, 2019)
  • Pain Intensity (Average) [ Time Frame: 3 months ]
    Rate average pain intensity using visual analog scale on a scale of 0-10, where 0 is no pain and 10 is worst possible pain. Higher scores mean a worse outcome.
  • Average Pain Interference [ Time Frame: 3 months ]
    This measures the average pain interference with general activity, mood, walking ability, normal work, relations with others, sleep and enjoyment of life using visual analogue scale. On a scale of 0-10, 0 is no interference and 10 is extreme interference. Higher scores mean worse outcome.
  • Pain Disability Index [ Time Frame: 3 months ]
    The Pain Disability Index (PDI) a simple and rapid instrument for measuring the impact that pain has on the ability of a person to participate in essential life activities. For each of the 7 categories of life activity listed, a score of 0 means no disability at all, and a score of 10 signifies that all of the activities in which you would normally be involved have been totally disrupted or prevented by your pain. The minimal index is 0 and maximal index is 70. The higher the index the greater the person's disability due to pain meaning a worse outcome.
  • Pain Catastrophizing Scale [ Time Frame: 3 months ]
    Pain Catastrophizing Scale (PCS) has thirteen statements describing different thoughts and feelings that may be associated with pain. Using a 5-point scale from 0 (Not at all) to 4 (all the time), people indicate the degree to which they have these thoughts and feelings when they are experiencing pain. The sum has a minimum of 0 and a maximum of 52. Higher scores mean high levels of pain catastrophizing and worse outcome.
  • Hospital Anxiety and Depression Scale Total Score [ Time Frame: 3 months ]
    Hospital Anxiety and Depression Scale (HADS) is commonly used to determine the levels of anxiety and depression that a person is experiencing. The HADS is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. This outcome is a total score, which was calculated by adding the anxiety score and the depression score. Total score ranges from 0-42, with higher scores indicating a worse outcome.
Original Primary Outcome Measures  ICMJE
 (submitted: October 25, 2016)
Pain intensity [ Time Frame: 3 months ]
pain assessments on 0-10 scale
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 4, 2019)
Post-study Helpfulness Questionnaire [ Time Frame: 3 months ]
The questionnaire asked the participants to rate how helpful was the device for the low back pain on a scale of 0-10. 0 is not helpful at all and 10 is very helpful. Higher value means better outcome.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Efficacy of the Quell Wearable Device for Chronic Low Back Pain
Official Title  ICMJE Efficacy of the Quell Wearable Device for Chronic Low Back Pain
Brief Summary This is a 1-year trial designed to gather information about the use of the Quell for persons with chronic musculoskeletal low back pain.
Detailed Description Research Objectives: This is a 1-year trial designed to gather information about the use of the Quell for persons with chronic musculoskeletal low back pain. The investigators hypothesize that those assigned to using the device will report reduced back pain compared with those in the control condition; with those using the device also showing improvement in sleep, mood, and level of activity. The investigators hypothesize that frequency of using the Quell (increased tolerability and adherence) will be correlated with greater reduction in pain. The investigators hypothesize that the device will be safe to use and will demonstrate a reduction in healthcare utilization (reduced clinic and Emergency Department visits). Finally, based on preliminary analyses limited by few subject numbers, the investigators will investigate whether certain individuals report greater benefit from using the Quell than others and, in particular, would predict that those with more intense and longer duration of pain will demonstrate most benefit.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Low Back Pain
Intervention  ICMJE Device: Quell
Study Arms  ICMJE
  • Experimental: Experimental
    Subjects will receive the Quell device
    Intervention: Device: Quell
  • No Intervention: Control
    Subjects will not receive the Quell device
Publications * Jamison RN, Wan L, Edwards RR, Mei A, Ross EL. Outcome of a High-Frequency Transcutaneous Electrical Nerve Stimulator (hfTENS) Device for Low Back Pain: A Randomized Controlled Trial. Pain Pract. 2019 Jun;19(5):466-475. doi: 10.1111/papr.12764. Epub 2019 Feb 4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 4, 2019)
Original Estimated Enrollment  ICMJE
 (submitted: October 25, 2016)
Actual Study Completion Date  ICMJE August 2018
Actual Primary Completion Date August 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT02944513
Other Study ID Numbers  ICMJE 2016P002172
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Robert N. Jamison, PhD, Brigham and Women's Hospital
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Brigham and Women's Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Brigham and Women's Hospital
Verification Date April 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP