Efficacy of the Quell Wearable Device for Chronic Overlapping Pain Conditions

Study Overview
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Brief Summary
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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.

Detailed Description
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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. Participants will attend two quantitative sensory testing visits in order to determine their level of pain sensitivity, one at the beginning of the study and the second at the 3-month Follow-up session. Participants will be asked to test out the Quell device to check for sensation tolerance, and will then be randomized into one of the two treatment groups: the High Intensity Quell group or the Low Intensity Quell group. Participants will be asked to wear the device for at least 3 hours every day and to complete daily assessments, along with a total of three sets of questionnaires: one at the start of the study, the second 6 weeks from the date of consent, and the third 3 months after the date of consent. A member of the research staff will call participants once a week for a brief phone interview throughout the study. Participants will be in this study for 3 months.

Official Title
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Efficacy of the Quell Wearable Device for Treatment of Central Sensitization-related Pain Among Persons With Chronic Overlapping Pain Conditions

Conditions
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Chronic Pain, Adults 21 and Older, Multiple Chronic Overlapping Pain Conditions, Hypersensitivity

Intervention / Treatment
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* Device: High Intensity Quell
* Device: Low Intensity Quell


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be equally randomized to one of the two treatment groups: the High Intensity Quell group or the Low Intensity Quell group. All groups will receive the same questionnaires and undergo quantitative sensory testing.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: High Intensity Stimulation<br>Patients will be randomly assigned to the High Intensity Quell group and will receive higher intensity stimulation every day for 12 weeks. | Device: High Intensity Quell<br>* Participants will receive 1 hour of continuous stimulation during each therapy session. Subjects are asked to complete a minimum of 3 sessions per day.<br>|
| Sham Comparator: Low Intensity Stimulation<br>Patients will be randomly assigned to the Low intensity Quell group and will receive lower intensity stimulation every day for 12 weeks. | Device: Low Intensity Quell<br>* Participants will receive only three 2-minute periods of stimulation (at 0, 28, 58 minutes) during each 60-minute therapeutic session. Subjects are asked to complete a minimum of 3 sessions per day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Brief Pain Inventory Interference Scale (BPI) | Measures and validates measures of pain intensity on a scale of 0-10 with higher scores meaning a worse outcome | Changes from Baseline to 3-month Follow-Up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Catastrophizing Scale (PCS) | Measures thoughts and feelings when patient is experiencing pain on a 13-item scale ranging from 0-52 with higher scores meaning a worse outcome and higher catastrophizing | Changes from Baseline to 3-month Follow-Up | 
| Pain Disability Index (PDI) | Rating scales designed to measure levels of pain disability, or the degree to which pain is preventing a patient from doing what they normally would be doing, or doing it as well as they normally would on a 7-item scale of 0-10 ranging from 0-70 with higher scores meaning a worse outcome | Changes from Baseline to 3-month Follow-Up | 
| Hospital Anxiety and Depression Scale (HADS) | Measures mood on a 14-item scale ranging from 0 to 42 with higher scores meaning a worse outcome | Changes from Baseline to 3-month Follow-Up | 
| Pain Detect Neuropathic Pain Questionnaire (painDETECT) | Measures the presence of neuropathic pain on a scale ranging from -1 to 38 on ratings of 'never to very strongly' with higher scores meaning a worse outcome | Changes from Baseline to 3-month Follow-Up | 
| Symptom Impact Questionnaire (SIQR) | Measures pain symptoms and function on a scale of 0-10 with scores ranging from 0 to-50 with higher scores meaning a worse outcome | Changes from Baseline to 3-month Follow-Up | 
| Patient's Global Impression of Change (PGIC) | Measures the subject's overall belief about the efficacy of treatment on a 7-point categorical verbal rating scale. The scale ranges from (1) no change or condition has gotten worse to (7) a great deal better and a considerable improvement that has made all the difference. | Changes from Baseline to 3-month Follow-Up | 
| Healthcare Utilization | Monthly clinic and ED visits | Changes from Baseline to 3-month Follow-Up | 
| Satisfaction and Qualitative Questions | Overall satisfaction questions developed for this study, specifically related to use of a pain management device | 3-month Follow-up | 
| Quantitative Sensory Testing (QST) | Set of psychophysical methods used to quantify somatosensory function | Changes from Baseline to 3-month Follow-Up | 
| The Brief Pain Inventory Pain Intensity Scale (BPI) | Worst, least, average and now pain on a scale of 0-10 with higher scores meaning a worse outcome | Changes from Baseline to 3-month Follow-Up | 
| MasterMyPain App | Daily ratings of pain related factors on smartphone pain app on a scale of 0-10 with higher scores meaning a worse outcome | Daily ratings over 3-months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Chronic Overlapping Pain Conditions, Adults 21 and older