Efficacy of the Quell Wearable Device for Chronic Overlapping Pain Conditions

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05540002
• Other study ID #: 2022P002083
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Chronic Pain
• Disease
• Hypersensitivity

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

External Links

•   Link to rally website to Quell COPCs