Clinical trial NCT02944513: Efficacy of the Quell Wearable Device for Chronic Low Back Pain
Official title: Efficacy of the Quell Wearable Device for Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2016-10-26
Enrollment: 68
Sex: ALL
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Pain Intensity (Average)
timeFrame: 3 months
measure: Average Pain Interference
timeFrame: 3 months
measure: Pain Disability Index
timeFrame: 3 months
measure: Pain Catastrophizing Scale
timeFrame: 3 months
measure: Hospital Anxiety and Depression Scale Total Score
timeFrame: 3 months
Secondary outcomes:
measure: Post-study Helpfulness Questionnaire
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References:
citation: 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.