Efficacy of the Quell Wearable Device for Fibromyalgia

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03714425

Enrollment

119

Registered

2018-10-22

Start date

2019-02-01

Completion date

2020-12-01

Last updated

2022-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgia

Brief summary

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

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.

Interventions

DEVICEQuell

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Intervention model description

High frequency device vs. Low frequency device

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. have chronic pain related to FM 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 4. have a smartphone (Android or iPhone)

Exclusion criteria

1. diagnosis of cancer or any other malignant disease 2. acute osteomyelitis or acute bone disease 3. present or past DSM-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. have an implanted cardiac pacemaker, defibrillator, or other implanted device

Design outcomes

Primary

Measure	Time frame	Description
Patients' Global Impression of Change	3 months	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.

Secondary

Measure	Time frame	Description
Revised Fibromyalgia Impact Questionnaire	Baseline, 3 months	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.
Pain Catastrophizing Scale	Baseline, 3 months	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.
The Brief Pain Inventory	Baseline, 3 months	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.
Hospital Anxiety and Depression Scale	Baseline, 3 months	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.
Helpfulness Rating	Post-treatment at 3 months	Self-report rating How helpful was the TENS for your fibromyalgia? 0=not at all helpful, 10=very helpful.
Pain Disability Index	Baseline, 3 months	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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
High Frequency Device Subjects will use high frequency Quell devices. Quell: 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.	62
Low Frequency Device Subjects will use low frequency Quell devices. Quell: 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.	57
Total	119

Baseline characteristics

Characteristic	Low Frequency Device	Total	High Frequency Device
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	5 Participants	10 Participants	5 Participants
Age, Categorical Between 18 and 65 years	52 Participants	109 Participants	57 Participants
Age, Continuous	52.3 years STANDARD_DEVIATION 13.8	50.4 years STANDARD_DEVIATION 13.5	48.3 years STANDARD_DEVIATION 13.1
Race (NIH/OMB) American Indian or Alaska Native	1 Participants	2 Participants	1 Participants
Race (NIH/OMB) Asian	0 Participants	1 Participants	1 Participants
Race (NIH/OMB) Black or African American	5 Participants	10 Participants	5 Participants
Race (NIH/OMB) More than one race	4 Participants	11 Participants	7 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	47 Participants	95 Participants	48 Participants
Region of Enrollment United States	57 participants	119 participants	62 participants
Sex: Female, Male Female	53 Participants	111 Participants	58 Participants
Sex: Female, Male Male	4 Participants	8 Participants	4 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 62	0 / 57
other Total, other adverse events	0 / 62	0 / 57
serious Total, serious adverse events	0 / 62	0 / 57

Outcome results

Primary

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.

Time frame: 3 months

Arm	Measure	Value (MEAN)
High Frequency Device	Patients' Global Impression of Change	3.58 score on a scale
Low Frequency Device	Patients' Global Impression of Change	3.24 score on a scale

Secondary

Helpfulness Rating

Self-report rating How helpful was the TENS for your fibromyalgia? 0=not at all helpful, 10=very helpful.

Time frame: Post-treatment at 3 months

Arm	Measure	Value (MEAN)	Dispersion
High Frequency Device	Helpfulness Rating	4.8 score on a scale	Standard Deviation 3.5
Low Frequency Device	Helpfulness Rating	4.8 score on a scale	Standard Deviation 2.6

Secondary

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.