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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05540002
Other study ID # 2022P002083
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 14, 2022
Est. completion date October 2024

Study information

Verified date April 2024
Source Brigham and Women's Hospital
Contact Robert N. Jamison, Ph.D.
Phone 617-732-9046
Email rjamison@bwh.harvard.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Recruiting
Enrollment 115
Est. completion date October 2024
Est. primary completion date October 2024
Accepts healthy volunteers No
Gender All
Age group 21 Years to 99 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
United States Brigham and Women's Hospital Pain Management Center Chestnut Hill Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Brigham and Women's Hospital NeuroMetrix, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary Healthcare Utilization Monthly clinic and ED visits Changes from Baseline to 3-month Follow-Up
Secondary Satisfaction and Qualitative Questions Overall satisfaction questions developed for this study, specifically related to use of a pain management device 3-month Follow-up
Secondary Quantitative Sensory Testing (QST) Set of psychophysical methods used to quantify somatosensory function Changes from Baseline to 3-month Follow-Up
Secondary 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
Secondary 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
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