Efficacy of the Quell Wearable Device for Chronic Overlapping Pain Conditions

Efficacy of the Quell Wearable Device for Treatment of Central Sensitization-related Pain Among Persons With 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.

Study Overview

• Status: Recruiting
• Conditions: Hypersensitivity; Chronic Pain; Adults 21 and Older; Multiple Chronic Overlapping Pain Conditions
• Intervention / Treatment: Device: High Intensity Quell; Device: Low Intensity Quell

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.

• Study Type: Interventional
• Enrollment (Anticipated): 115
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Robert N. Jamison, Ph.D.; Phone Number: 617-732-9046; Email: rjamison@bwh.harvard.edu
• Study Contact Backup: Name: Carlicia D. Nelson, BA; Phone Number: 617-732-9718; Email: cnelson18@bwh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Chestnut Hill, Massachusetts, United States, 02467
      • Recruiting
      • Brigham and Women's Hospital Pain Management Center
      • Contact: Robert N. Jamison, Ph.D.; Phone Number: 617-732-9046; Email: rjamison@bwh.harvard.edu
      • Contact: Carlicia D. Nelson, BA; Phone Number: 617-732-9718; Email: cnelson18@bwh.harvard.edu
      • Principal Investigator: Robert N. Jamison, Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 97 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Device: 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.
Sham Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Brief Pain Inventory Interference Scale (BPI)	Measures and validates measures of pain intensity on a scale of 0-10 with higher scores meaning a worse outcome	Changes from Baseline to 3-month Follow-Up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	Changes from Baseline to 3-month Follow-Up
Symptom Impact Questionnaire (SIQR)	Measures pain symptoms and function on a scale of 0-10 with scores ranging from 0 to-50 with higher scores meaning a worse outcome	Changes from Baseline to 3-month Follow-Up
Patient's Global Impression of Change (PGIC)	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.	Changes from Baseline to 3-month Follow-Up
Healthcare Utilization	Monthly clinic and ED visits	Changes from Baseline to 3-month Follow-Up
Satisfaction and Qualitative Questions	Overall satisfaction questions developed for this study, specifically related to use of a pain management device	3-month Follow-up
Quantitative Sensory Testing (QST)	Set of psychophysical methods used to quantify somatosensory function	Changes from Baseline to 3-month Follow-Up
The Brief Pain Inventory Pain Intensity Scale (BPI)	Worst, least, average and now pain on a scale of 0-10 with higher scores meaning a worse outcome	Changes from Baseline to 3-month Follow-Up
MasterMyPain App	Daily ratings of pain related factors on smartphone pain app on a scale of 0-10 with higher scores meaning a worse outcome	Daily ratings over 3-months

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: NeuroMetrix, Inc.
• Investigators: Principal Investigator: Robert N. Jamison, Ph.D., Brigham and Women's Hospital

Publications and helpful links

Helpful Links

• Link to rally website to Quell COPCs

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2022
• Primary Completion (Anticipated): October 1, 2023
• Study Completion (Anticipated): October 1, 2024

Study Registration Dates

• First Submitted: September 12, 2022
• First Submitted That Met QC Criteria: September 12, 2022
• First Posted (Actual): September 14, 2022

Study Record Updates

• Last Update Posted (Actual): November 15, 2022
• Last Update Submitted That Met QC Criteria: November 10, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Multiple Chronic Overlapping Pain Conditions; Adults 21 and older
• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Pain; Neurologic Manifestations; Hypersensitivity; Disease; Chronic Pain
• Other Study ID Numbers: 2022P002083

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes