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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
Sponsor:
Information provided by (Responsible Party):
Robert N. Jamison, PhD, Brigham and Women's Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Low Back Pain Device: Quell Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of the Quell Wearable Device for Chronic Low Back Pain
Actual Study Start Date : October 2016
Actual Primary Completion Date : August 2018
Actual Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

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


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 99 Years   (Adult, Older Adult)
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 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.
Contacts and Locations
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No Contacts or Locations Provided
  Study Documents (Full-Text)

Documents provided by Robert N. Jamison, PhD, Brigham and Women's Hospital:
Study Protocol and Statistical Analysis Plan  [PDF] July 1, 2016

More Information
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Publications of Results:

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Responsible Party: Robert N. Jamison, PhD, Professor, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT02944513    
Other Study ID Numbers: 2016P002172
First Posted: October 26, 2016    Key Record Dates
Results First Posted: February 26, 2019
Last Update Posted: April 25, 2022
Last Verified: April 2022
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations