Efficacy of the Quell Wearable Device for Chronic Overlapping Pain Conditions

Not Applicable

Completed

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

Interventions: Device: Low Intensity Quell
Device: High Intensity Quell

Registration Number: NCT05540002

Lead Sponsor: Brigham and Women's Hospital

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 115

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low Intensity Stimulation	Low Intensity Quell	Patients will be randomly assigned to the Low intensity Quell group and will receive lower intensity stimulation every day for 12 weeks.
High Intensity Stimulation	High Intensity Quell	Patients will be randomly assigned to the High Intensity Quell group and will receive higher intensity stimulation every day for 12 weeks.

Primary Outcome Measures

Name	Time	Method
The Brief Pain Inventory Interference Scale (BPI)	Between group differences at 3-months	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.

Secondary Outcome Measures

Name	Time	Method
Pain Catastrophizing Scale (PCS)	Changes from Baseline to 3-month Follow-Up	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
Pain Disability Index (PDI)	Changes from Baseline to 3-month Follow-Up	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
Hospital Anxiety and Depression Scale (HADS)	Changes from Baseline to 3-month Follow-Up	Measures mood on a 14-item scale ranging from 0 to 42 with higher scores meaning a worse outcome
Pain Detect Neuropathic Pain Questionnaire (painDETECT)	Changes from Baseline to 3-month Follow-Up	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
Symptom Impact Questionnaire (SIQR)	Changes from Baseline to 3-month Follow-Up	Measures 20 pain symptoms and function on a scale of 0-10 with scores ranging from 0 to 200 with higher scores meaning a worse outcome
Patient's Global Impression of Change (PGIC)	Changes from Baseline to 3-month Follow-Up	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.
Healthcare Utilization	Changes from Baseline to 3-month Follow-Up	Monthly clinic and ED visits
Satisfaction and Qualitative Questions	3-month Follow-up	A satisfaction questionnaire was developed for this study specifically related to use of the pain management device (Quell) and use of the study app. Ten items related to use of the device and five items were related to use of the smartphone study app all rated on a scale of 0 (worse) to 10 (better). Below are group differences on "How willing would you be to using the Quell in the future?" rated from 0=Not at all willing to 10=Very willing. This questionnaire was only administered at the end of the trial.
Quantitative Sensory Testing (QST)	Changes from Baseline to 3-month Follow-Up	Set of psychophysical methods used to quantify somatosensory function. Combined hypersensitivity measure that measures responses to repeated touch, mechanical/pressure pain assessment, and cold pain assessment. Overall sensitivity based on z scores categorized into high and low sensitivity. Higher scores represent less sensitivity. The mean score is 0.
The Brief Pain Inventory Pain Intensity Scale (BPI)	Changes from Baseline to 3-month Follow-Up	Average pain on a scale of 0-10 with higher scores meaning a worse outcome
MasterMyPain App	Daily ratings over 3-months	Daily ratings of pain related factors on smartphone pain app on a scale of 0-10 with higher scores meaning a worse outcome. Multiple daily assessments were averaged for mean and standard deviation scores.