Efficacy of the Quell Wearable Device for Chronic Overlapping Pain Conditions

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

115 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-14

Study Completion Date

2024-09-19

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.

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Neither the principal investigator, the co-investigators, the research assistant, or the subjects will know if they are given the high intensity Quell device or the low intensity Quell device.

Study Groups

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High Intensity Stimulation

Patients will be randomly assigned to the High Intensity Quell group and will receive higher intensity stimulation every day for 12 weeks.

Group Type ACTIVE_COMPARATOR

High Intensity Quell

Intervention Type DEVICE

Participants will receive 1 hour of continuous stimulation during each therapy session. Subjects are asked to complete a minimum of 3 sessions per day.

Low Intensity Stimulation

Patients will be randomly assigned to the Low intensity Quell group and will receive lower intensity stimulation every day for 12 weeks.

Group Type SHAM_COMPARATOR

Low Intensity Quell

Intervention Type DEVICE

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.

Interventions

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High Intensity Quell

Participants will receive 1 hour of continuous stimulation during each therapy session. Subjects are asked to complete a minimum of 3 sessions per day.

Intervention Type DEVICE

Low Intensity Quell

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.

Intervention Type DEVICE

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

Minimum Eligible Age

21 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No