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Completed

NCT Number: NCT05540002

Efficacy of the Quell Wearable Device for 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.

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Key information

Conditions

Chronic Pain Adults 21 and Older Hypersensitivity Immune System Diseases Multiple Chronic Overlapping Pain Conditions Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

21 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital Pain Management Center

Chestnut Hill, Massachusetts, 02467, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. The Brief Pain Inventory Interference Scale (BPI)

    Time frame: 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 outcomes

  1. Pain Catastrophizing Scale (PCS)

    Time frame: 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

  2. Pain Disability Index (PDI)

    Time frame: 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

  3. Hospital Anxiety and Depression Scale (HADS)

    Time frame: 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

  4. Pain Detect Neuropathic Pain Questionnaire (painDETECT)

    Time frame: 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

  5. Symptom Impact Questionnaire (SIQR)

    Time frame: 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

  6. Patient's Global Impression of Change (PGIC)

    Time frame: 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.

  7. Healthcare Utilization

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

    Monthly clinic and ED visits

  8. Satisfaction and Qualitative Questions

    Time frame: 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.

  9. Quantitative Sensory Testing (QST)

    Time frame: 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.

  10. The Brief Pain Inventory Pain Intensity Scale (BPI)

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

    Average pain on a scale of 0-10 with higher scores meaning a worse outcome

  11. MasterMyPain App

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • NeuroMetrix, Inc.

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Sep 14, 2022
Registry last updated
Mar 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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