Efficacy of the Quell Wearable Device for Fibromyalgia

Study Overview
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Brief Summary
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This study is designed for patients with primary fibromyalgia (FM) pain. The overall aim of the study is to determine the effect of the high frequency Quell device to manage FM compared with a low frequency device. Investigators hypothesize that those assigned to using the high frequency Quell device will report reduced pain compared with those using the low frequency Quell device; with those using the high frequency device also showing more improvement in sleep, mood, and level of activity. Investigators also hypothesize that frequency of using the Quell (increased tolerability and adherence) will be correlated with greater reduction in pain.

Detailed Description
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The Quell is battery powered with rechargeable batteries and is strapped to participant's upper calf with a velcro band. It has been cleared by the FDA for safety. It is designed to improve fibromyalgia by the principles of transcutaneous electrical stimulation of nerves much like a traditional transcutaneous electrical nerve stimulator (TENS) unit. Investigators expect to enroll approximately 130 subjects in this study. Participants will be equally randomized to one of two experimental groups: High Frequency Quell group (N=65) or Low Frequency Quell group (N=65). This study hopes to find out whether low frequency or high frequency stimulation is most useful among persons with fibromyalgia.

Official Title
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Efficacy of the Quell Wearable Device for Fibromyalgia

Conditions
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Fibromyalgia

Intervention / Treatment
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* Device: Quell


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: have chronic pain related to FM for > 3 months' duration average 4 or greater on a pain intensity scale of 0 to 10 are able to speak and understand English have a smartphone (Android or iPhone) Exclusion Criteria: diagnosis of cancer or any other malignant disease acute osteomyelitis or acute bone disease present or 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 (positive on the Mini International Neuropsychiatric Interview; M.I.N.I. v.5.0), that would interfere with study participation have an implanted cardiac pacemaker, defibrillator, or other implanted device

Ages Eligible for Study
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Minimum Age: 18 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: High frequency device vs. Low frequency device
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: High frequency device<br>Subjects will use high frequency Quell devices. | Device: Quell<br>* Quell is a Transcutaneous Electrical Nerve Stimulator Device (TENS). The device will use nerve stimulation to treat chronic pain by sending signals to the brain that cause it to release natural opioids.<br>|
| Sham Comparator: Low frequency device<br>Subjects will use low frequency Quell devices. | Device: Quell<br>* Quell is a Transcutaneous Electrical Nerve Stimulator Device (TENS). The device will use nerve stimulation to treat chronic pain by sending signals to the brain that cause it to release natural opioids.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients' Global Impression of Change | The questionnaire reflects a patient's belief about the efficacy of treatment. The Patients' Global Impression of Change (PGIC) is a 7-point scale (1-7) depicting a patient's rating of overall improvement. Patients rate their change as 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, or 7=very much worse. Lower values represent a better outcome. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Brief Pain Inventory | The Brief Pain Inventory assesses the severity of pain and its impact on functioning. Pain Severity Score is calculated by adding the scores for questions 2, 3, 4 and 5 and then dividing by 4. This gives a severity score out of 10 (0-10), where 0 means no pain and 10 is worst possible pain. Pain Interference Score is calculated by adding the scores for questions 8a, b, c, d, e, f and g and then dividing by 7. This gives an interference score out of 10 (0-10), where 0 means does not interfere and 10 means completely interferes. Lower values represent a better outcome. | Baseline, 3 months | 
| Revised Fibromyalgia Impact Questionnaire | The Revised Fibromyalgia Impact Questionnaire (FIQR) is an assessment and evaluation instrument developed to measure fibromyalgia (FM) patient status, progress and outcomes. The FIQR has 3 domains: function, overall impact and symptoms. FIQR has 21 individual questions and all questions are based on an 11-point numeric rating scale of 0 to 10, with 10 being 'worst'. The summed score for function (range 0 to 90) is divided by 3, the summed score for overall impact (range 0 to 20) is not changed, and the summed score for symptoms (range 0 to 100) is divided by 2. The total FIQR is the sum of the three domain scores. The total score of the FIQR ranges from 0 to 100. Lower values represent a better outcome. | Baseline, 3 months | 
| Pain Catastrophizing Scale | The Pain Catastrophizing Scale (PCS) instructions ask participants to reflect on past painful experiences, and to indicate the degree to which they experienced each of 13 thoughts or feelings when experiencing pain, on 5-point scales with the end points (0) not at all and (4) all the time. The total score is computed by summing responses to all 13 items (scale 0-4). PCS total scores range from 0 - 52. The higher the score, the more catastrophizing thoughts are present. Lower values represent a better outcome. | Baseline, 3 months | 
| Pain Disability Index | The Pain Disability Index is a simple and rapid instrument for measuring the impact that pain has on the ability of a person to participate in essential life activities. The total score is a sum of all 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 people would normally be involved have been totally disrupted or prevented by the pain. The total index ranges from 0 to 70. The higher the index the greater the person's disability due to pain. Lower values represent a better outcome. | Baseline, 3 months | 
| Hospital Anxiety and Depression Scale | The Hospital Anxiety and Depression Scale (HADS) was developed to assess depression and anxiety in patients. Responses are rated on a scale from 0 to 3, with higher scores indicating higher severity. The ratings of the 14 items are summed to yield a total score (0 to 42), or for each subscale separately (0 to 21). 0 to 7 for normal or no anxiety/depression, 8 to 10 for mild, 11 to 14 for moderate, and 12 to 21 for severe anxiety/depression. Lower values represent a better outcome. | Baseline, 3 months | 
| Helpfulness Rating | Self-report rating How helpful was the TENS for your fibromyalgia? 0=not at all helpful, 10=very helpful. | Post-treatment at 3 months |