Efficacy of the Quell Wearable Device for Chronic Overlapping Pain Conditions

Brigham and Women's Hospital115 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

115

Conditions

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

Interventions

High Intensity QuellDEVICE

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 QuellDEVICE

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.

Eligibility

Sex: ALLMin age: 21 YearsMax age: 99 Years

Medical Language ↔ Plain English

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

Locations (1)

Brigham and Women's Hospital Pain Management Center

Chestnut Hill, Massachusetts, United States

Outcomes

Primary Outcomes

The Brief Pain Inventory Interference Scale (BPI)

This is a validated measure of combined activity interference on a numerical scale of 0-10, with higher scores representing greater activity interference. We collected ratings on how much pain interfered over the past 24 hours with 1) General activity, 2) Mood, 3) Walking ability, 4) Normal work, 5) Relations with other people, 6) Sleep, and 7) Enjoyment of life on a scale of 0=does not interfere to 10=completely interferes. The table represents combined mean scores between groups. These ratings were collected at 3 months after start of the study.

Time frame: Between group differences at 3-months

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Changes from Baseline to 3-month Follow-Up

Data from ClinicalTrials.gov

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