N/A
Completed N=68
Efficacy of the Quell Wearable Device for Chronic Low Back Pain
Source: ClinicalTrials.gov NCT02944513 ↗Enrolled (actual)
68
Serious AEs
0.0%
Results posted
Feb 2019
Primary outcomePrimary: Pain Intensity (Average) — 4.0; 5.7 score on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Intensity (Average) |
4.0; 5.7 | — |
| PRIMARY Average Pain Interference |
3.2; 5.4 | — |
| PRIMARY Pain Disability Index |
26.3; 34.9 | — |
| PRIMARY Pain Catastrophizing Scale |
13.9; 25.1 | — |
| PRIMARY Hospital Anxiety and Depression Scale Total Score |
15.2; 16.6 | — |
| SECONDARY Post-study Helpfulness Questionnaire |
4.7; NA | — |
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:
- have chronic pain for > 3 months' duration
- average 4 or greater on a pain intensity scale of 0 to 10
- are able to speak and understand English.
Exclusion Criteria
- Patients will be excluded from participation if they meet any of the following criteria:
- diagnosis of cancer or any other malignant disease
- acute osteomyelitis or acute bone disease
- 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
- pregnancy
- any clinically unstable systemic illness judged to interfere with treatment
- a pain condition requiring urgent surgery
- 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
- any prescription opioid use for pain
- have an implanted cardiac pacemaker, defibrillator, or other implanted device. All subjects will be asked to not change their treatment during the study period.
Data sourced from ClinicalTrials.gov (NCT02944513). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.