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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 : Not yet recruiting
First Posted : October 26, 2016
Last Update Posted : October 26, 2016
Sponsor:
Information provided by (Responsible Party):
Robert N. Jamison, PhD, Brigham and Women's Hospital

Brief Summary:
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 ED 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.

Condition or disease Intervention/treatment Phase
Low Back Pain Device: Quell Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 69 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : October 2016
Estimated Primary Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Experimental
Subjects will receive the Quell device
Device: Quell
No Intervention: Control
Subjects will not receive the Quell device



Primary Outcome Measures :
  1. Pain intensity [ Time Frame: 3 months ]
    pain assessments on 0-10 scale



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 smartphone 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 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. 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.

Responsible Party: Robert N. Jamison, PhD, Professor, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT02944513     History of Changes
Other Study ID Numbers: 2016P002172
First Posted: October 26, 2016    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms