Efficacy of the Quell Wearable Device for Chronic Overlapping Pain Conditions

NCT05540002 | Completed Results FDA Device

• 1 other identifier: 2022P002083
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Multiple Chronic Overlapping Pain Conditions; Adults 21 and older

Outcome Measures

Primary Outcomes (1)

• 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.

  Between group differences at 3-months

Secondary Outcomes (11)

• Pain Catastrophizing Scale (PCS)

  Changes from Baseline to 3-month Follow-Up

• Pain Disability Index (PDI)

  Changes from Baseline to 3-month Follow-Up

• Hospital Anxiety and Depression Scale (HADS)

  Changes from Baseline to 3-month Follow-Up

• Pain Detect Neuropathic Pain Questionnaire (painDETECT)

  Changes from Baseline to 3-month Follow-Up

• Symptom Impact Questionnaire (SIQR)

  Changes from Baseline to 3-month Follow-Up

Study Arms (2)

High Intensity Stimulation

ACTIVE COMPARATOR

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

Low Intensity Stimulation

SHAM COMPARATOR

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

Interventions

High Intensity Quell 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.

High Intensity Stimulation

Low Intensity Quell 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.

Low Intensity Stimulation

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• NeuroMetrix, Inc.: collaborator

Study Sites (1)

Brigham and Women's Hospital Pain Management Center

Chestnut Hill, Massachusetts, 02467, United States

Location

Related Links

• Link to rally website to Quell COPCs

MeSH Terms

Conditions

Chronic Pain; Hypersensitivity

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Immune System Diseases

Limitations and Caveats

There were several limitations. The study included a limited number of subjects. Subjects were only followed for 3 months. The subjects had other medical comorbidities.

Results Point of Contact

• Title: Robert Jamison
• Organization: Brigham and Women's Hospital

rjamison@bwh.harvard.edu

617-732-9046

Study Officials

• Robert N. Jamison, Ph.D.

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: September 12, 2022
• First Posted: September 14, 2022
• Study Start: October 14, 2022
• Primary Completion: September 19, 2024
• Study Completion: September 19, 2024
• Last Updated: March 19, 2025
• Results First Posted: March 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)