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Efficacy of the Quell Wearable Device for Chronic Overlapping Pain Conditions

Primary Purpose

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

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High Intensity Quell
Low Intensity Quell
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring Multiple Chronic Overlapping Pain Conditions, Adults 21 and older

Eligibility Criteria

21 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Brigham and Women's Hospital Pain Management CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

High Intensity Stimulation

Low Intensity Stimulation

Arm Description

Patients will be randomly assigned to the High Intensity Quell group and will receive higher intensity stimulation every day for 12 weeks.

Patients will be randomly assigned to the Low intensity Quell group and will receive lower intensity stimulation every day for 12 weeks.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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
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
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
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.
Healthcare Utilization
Monthly clinic and ED visits
Satisfaction and Qualitative Questions
Overall satisfaction questions developed for this study, specifically related to use of a pain management device
Quantitative Sensory Testing (QST)
Set of psychophysical methods used to quantify somatosensory function
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
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

Full Information

First Posted
September 12, 2022
Last Updated
November 10, 2022
Sponsor
Brigham and Women's Hospital
Collaborators
NeuroMetrix, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05540002
Brief Title
Efficacy of the Quell Wearable Device for Chronic Overlapping Pain Conditions
Official Title
Efficacy of the Quell Wearable Device for Treatment of Central Sensitization-related Pain Among Persons With Chronic Overlapping Pain Conditions
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 14, 2022 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
NeuroMetrix, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Adults 21 and Older, Multiple Chronic Overlapping Pain Conditions, Hypersensitivity
Keywords
Multiple Chronic Overlapping Pain Conditions, Adults 21 and older

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantInvestigator
Masking Description
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.
Allocation
Randomized
Enrollment
115 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High Intensity Stimulation
Arm Type
Active Comparator
Arm Description
Patients will be randomly assigned to the High Intensity Quell group and will receive higher intensity stimulation every day for 12 weeks.
Arm Title
Low Intensity Stimulation
Arm Type
Sham Comparator
Arm Description
Patients will be randomly assigned to the Low intensity Quell group and will receive lower intensity stimulation every day for 12 weeks.
Intervention Type
Device
Intervention Name(s)
High Intensity Quell
Intervention Description
Participants will receive 1 hour of continuous stimulation during each therapy session. Subjects are asked to complete a minimum of 3 sessions per day.
Intervention Type
Device
Intervention Name(s)
Low Intensity Quell
Intervention Description
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 Outcome Measure Information:
Title
The Brief Pain Inventory Interference Scale (BPI)
Description
Measures and validates measures of pain intensity on a scale of 0-10 with higher scores meaning a worse outcome
Time Frame
Changes from Baseline to 3-month Follow-Up
Secondary Outcome Measure Information:
Title
Pain Catastrophizing Scale (PCS)
Description
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
Title
Pain Disability Index (PDI)
Description
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
Title
Hospital Anxiety and Depression Scale (HADS)
Description
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
Title
Pain Detect Neuropathic Pain Questionnaire (painDETECT)
Description
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
Title
Symptom Impact Questionnaire (SIQR)
Description
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
Time Frame
Changes from Baseline to 3-month Follow-Up
Title
Patient's Global Impression of Change (PGIC)
Description
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.
Time Frame
Changes from Baseline to 3-month Follow-Up
Title
Healthcare Utilization
Description
Monthly clinic and ED visits
Time Frame
Changes from Baseline to 3-month Follow-Up
Title
Satisfaction and Qualitative Questions
Description
Overall satisfaction questions developed for this study, specifically related to use of a pain management device
Time Frame
3-month Follow-up
Title
Quantitative Sensory Testing (QST)
Description
Set of psychophysical methods used to quantify somatosensory function
Time Frame
Changes from Baseline to 3-month Follow-Up
Title
The Brief Pain Inventory Pain Intensity Scale (BPI)
Description
Worst, least, average and now pain on a scale of 0-10 with higher scores meaning a worse outcome
Time Frame
Changes from Baseline to 3-month Follow-Up
Title
MasterMyPain App
Description
Daily ratings of pain related factors on smartphone pain app on a scale of 0-10 with higher scores meaning a worse outcome
Time Frame
Daily ratings over 3-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Robert N. Jamison, Ph.D.
Phone
617-732-9046
Email
rjamison@bwh.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Carlicia D. Nelson, BA
Phone
617-732-9718
Email
cnelson18@bwh.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert N. Jamison, Ph.D.
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital Pain Management Center
City
Chestnut Hill
State/Province
Massachusetts
ZIP/Postal Code
02467
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert N. Jamison, Ph.D.
Phone
617-732-9046
Email
rjamison@bwh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Carlicia D. Nelson, BA
Phone
617-732-9718
Email
cnelson18@bwh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Robert N. Jamison, Ph.D.

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://rally.massgeneralbrigham.org/study/_quellcopcs
Description
Link to rally website to Quell COPCs

Learn more about this trial

Efficacy of the Quell Wearable Device for Chronic Overlapping Pain Conditions

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