N/A
Completed N=115
Efficacy of the Quell Wearable Device for Chronic Overlapping Pain Conditions
Postoperative Pain · Adults 21 and Older · Multiple Chronic Overlapping Pain Conditions · Hypersensitivity
Source: ClinicalTrials.gov NCT05540002 ↗
Enrolled (actual)
115
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcomePrimary: The Brief Pain Inventory Interference Scale (BPI) — 5.7; 5.7 score on a scale
Summary
This study will examine the pain-relieving effects of a transcutaneous electrical nerve stimulator device called a Quell for persons with multiple chronic overlapping pain conditions.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Brief Pain Inventory Interference Scale (BPI) |
5.7; 5.7 | — |
| SECONDARY Pain Catastrophizing Scale (PCS) |
25.0; 24.8 | — |
| SECONDARY Pain Disability Index (PDI) |
38.3; 36.3 | — |
| SECONDARY Hospital Anxiety and Depression Scale (HADS) |
19.1; 16.9 | — |
| SECONDARY Pain Detect Neuropathic Pain Questionnaire (painDETECT) |
16.1; 16.5 | — |
| SECONDARY Symptom Impact Questionnaire (SIQR) |
115.8; 106.1 | — |
| SECONDARY Patient's Global Impression of Change (PGIC) |
4.2; 4.0 | — |
| SECONDARY Healthcare Utilization |
1.3; 1.6; 0.0; 0.1 | — |
| SECONDARY Satisfaction and Qualitative Questions |
7.6; 7.4 | — |
| SECONDARY Quantitative Sensory Testing (QST) |
0.6; 0.0 | — |
| SECONDARY The Brief Pain Inventory Pain Intensity Scale (BPI) |
-0.5; -1.0 | — |
| SECONDARY MasterMyPain App |
3.9; 5.1 | — |
Eligibility Criteria
Inclusion Criteria
- Ages 21 and older
- Pain duration > 3 months
- Diagnosed by physician with multiple chronic pain conditions
- Have chronic pain related to multiple chronic pain diagnoses (headaches, joint pain, back pain, or any of the other COPCs)
- Average 4 or greater on pain intensity scale of 0 to 10
- Pain is not accounted for by any other progressive disease (e.g., cancer, MS)
- Meets sensory hypersensitivity cutoffs based on QST-assessed evidence
- Own a smartphone (iPhone or Android device) and can download the pain app (MasterMyPain) and the Quell Relief mobile app onto their device
- Able to speak and understand English
Exclusion Criteria
- Diagnosis of cancer or any other malignant disease
- Acute osteomyelitis or acute bone disease
- Present of past DSM-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 that would interfere with study participation
- Have an implanted cardiac pacemaker, defibrillator, or other implanted device.
- Reynaud's syndrome
- Open cuts/sores
Data sourced from ClinicalTrials.gov (NCT05540002). 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.