Quell Opioid Reduction and Pain Relief in Patients With C... | NCT02809846

Name	Class
NeuroMetrix, Inc.	INDUSTRY

Quell Opioid Reduction and Pain Relief in Patients With C... | NCT02809846 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Quell Device	Active Comparator	Quell is a class II medical device with FDA 510(k) clearance for the symptomatic relief and management of chronic intractable pain, without a prescription. It operates by using an electrical stimulator to activate peripheral sensory nerves and trigger analgesia.	Device: Quell
Sham Quell Device	Sham Comparator	Identical to Active Comparator, but provides sub-therapeutic electronic stimulation.	Device: Sham Quell

Name	Type	Description	Arm Group Labels	Other Names
Quell	Device		Quell Device
Sham Quell

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Daily Opioid Use Assessed as Recorded by the Subject in Their Analgesia Diary.	The primary end point of this study was the difference in the change in daily opioid use between the active device group and the sham device group, assessed at weeks 2, 4, 6, 8, and 10 of the study as recorded by the subject in their analgesia diary. Participants documented which medication was taken, how much, and at what time. Dose and type of opioid pain medication was converted to morphine milliequivalents (MME) using conversion factors published by the Centers for Medicare and Medicaid Services (CMS)and combined as a daily dose for each day in a subject's analgesia journal.	Weeks: 2,4,6,8,10

Contacts/Locations Module

Name	Affiliation	Role
Lase Ajayi, MD	Scripps	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Scripps Translational Science Institute		La Jolla	California	92037	United States

Arm/Group Information

ID	Title	Description
FG000	Quell Device	Quell is a class II medical device with FDA 510(k) clearance for the symptomatic relief and management of chronic intractable pain, without a prescription. It operates by using an electrical stimulator to activate peripheral sensory nerves and trigger analgesia. For the active device, a therapy session consisted of one hour of continuous stimulation with high frequency electric nerve stimulation varying between 60 and 100 Hz. Quell
FG001	Sham Quell Device	Identical to Active Comparator, but provides sub-therapeutic electronic stimulation.For the sham device, a therapy session consisted of three 2-minute periods of stimulation at 0, 28 and 58 minutes with a frequency that also varied between 60 and 100 Hz Sham Quell

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG00017 subjects FG00116 subjects
COMPLETED		FG0008 subjects FG0019 subjects
NOT COMPLETED		FG0009 subjects FG0017 subjects

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Quell Device	Quell is a class II medical device with FDA 510(k) clearance for the symptomatic relief and management of chronic intractable pain, without a prescription. It operates by using an electrical stimulator to activate peripheral sensory nerves and trigger analgesia. For the active device, a therapy session consisted of one hour of continuous stimulation with high frequency electric nerve stimulation varying between 60 and 100 Hz. Quell

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change in Daily Opioid Use Assessed as Recorded by the Subject in Their Analgesia Diary.

The primary end point of this study was the difference in the change in daily opioid use between the active device group and the sham device group, assessed at weeks 2, 4, 6, 8, and 10 of the study as recorded by the subject in their analgesia diary. Participants documented which medication was taken, how much, and at what time. Dose and type of opioid pain medication was converted to morphine milliequivalents (MME) using conversion factors published by the Centers for Medicare and Medicaid Services (CMS)and combined as a daily dose for each day in a subject's analgesia journal.

Posted

Mean

Standard Deviation

MME

Weeks: 2,4,6,8,10

ID	Title	Description
OG000	Quell Device	Quell is a class II medical device with FDA 510(k) clearance for the symptomatic relief and management of chronic intractable pain, without a prescription. It operates by using an electrical stimulator to activate peripheral sensory nerves and trigger analgesia. For the active device, a therapy session consisted of one hour of continuous stimulation with high frequency electric nerve stimulation varying between 60 and 100 Hz. Quell

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Quell Device	Quell is a class II medical device with FDA 510(k) clearance for the symptomatic relief and management of chronic intractable pain, without a prescription. It operates by using an electrical stimulator to activate peripheral sensory nerves and trigger analgesia. For the active device, a therapy session consisted of one hour of continuous stimulation with high frequency electric nerve stimulation varying between 60 and 100 Hz. Quell

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Device sensitivity	Skin and subcutaneous tissue disorders		Non-systematic Assessment	One subject in the sham device group had increased sensitivity to the device electrodes. These adverse effects did not cause any physical harm, 3 individuals discontinued the study early due to device intolerance.

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Lase Ajayi	Scripps TSRI	785.218.1643		tajayi@scripps.edu

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Dec 16, 2016	Jan 17, 2019	Prot_000.pdf
SAP	No	Yes	No	Statistical Analysis Plan	Jan 17, 2019	Jan 9, 2020	SAP_001.pdf

Condition Browse Module

ID	Term
D010146	Pain
D001943	Breast Neoplasms
D011471	Prostatic Neoplasms
D015179	Colorectal Neoplasms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D009371	Neoplasms by Site

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG0020
Asian	BG0000 BG0010 BG0020
Native Hawaiian or Other Pacific Islander	BG0000 BG0011 BG0021
Black or African American	BG0004 BG0010 BG0024
White	BG00011 BG00114 BG00225
More than one race	BG0000 BG0010 BG0020
Unknown or Not Reported	BG0002 BG0011 BG0023

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Initially, a sample size of 20 participants per treatment group (active and sham) was selected to achieve 90% power to find a 20% difference in mean percent change in opioid consumption between the two groups with an estimated standard deviation of 22% and 80% power to detect the same difference with a standard deviation of 19% at a two-sided alpha = 0.05	Mixed Models Analysis	Multivariable analysis with mixed effect regression models were used to assess the effect of treatment group on the primary and secondary outcomes.	<0.05	Sensitivity analyses comparing use of data from all participants with use of participants with complete data only was also performed. Agreement between different measures representing the same variable type was assessed using correlation analyses.													Other	Bivariate associations between variables were assessed using statistical methods appropriate for the variable types. Baseline characteristics (demographics, other morbidities, baseline medication use, pain intensity and QOL) were compared between the two treatment groups to assess effectiveness of randomization and identify important covariates for multivariable analyses. Associations between demographic variables and primary and secondary endpoints were examined.	Similar models were used to assess associations of treatment group with secondary endpoints. Model fit was assessed by Akaike's Information Criteria to determine optimal covariance structure.