Trial Outcomes & Findings for Efficacy of the Quell Wearable Device for Chronic Overlapping Pain Conditions (NCT NCT05540002)

NCT ID: NCT05540002

Last Updated: 2025-03-19

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 115 participants
• Primary outcome timeframe: Between group differences at 3-months
• Results posted on: 2025-03-19

Participant Flow

Participant milestones

Measure	High Intensity Stimulation Patients will be randomly assigned to the High Intensity Quell group and will receive higher intensity stimulation every day for 12 weeks. 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 Stimulation Patients will be randomly assigned to the Low intensity Quell group and will receive lower intensity stimulation every day for 12 weeks. 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.
Overall Study STARTED	58	57
Overall Study COMPLETED	52	50
Overall Study NOT COMPLETED	6	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy of the Quell Wearable Device for Chronic Overlapping Pain Conditions

Baseline characteristics by cohort

Measure	High Intensity Stimulation n=58 Participants Patients will be randomly assigned to the High Intensity Quell group and will receive higher intensity stimulation every day for 12 weeks. 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 Stimulation n=57 Participants Patients will be randomly assigned to the Low intensity Quell group and will receive lower intensity stimulation every day for 12 weeks. 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.	Total n=115 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	46 Participants n=5 Participants	41 Participants n=7 Participants	87 Participants n=5 Participants
Age, Categorical >=65 years	12 Participants n=5 Participants	16 Participants n=7 Participants	28 Participants n=5 Participants
Sex/Gender, Customized Female	52 Participants n=5 Participants	45 Participants n=7 Participants	97 Participants n=5 Participants
Sex/Gender, Customized Male	5 Participants n=5 Participants	12 Participants n=7 Participants	17 Participants n=5 Participants
Sex/Gender, Customized Other	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	52 Participants n=5 Participants	49 Participants n=7 Participants	101 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) White	43 Participants n=5 Participants	44 Participants n=7 Participants	87 Participants n=5 Participants
Race (NIH/OMB) More than one race	6 Participants n=5 Participants	2 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	High Intensity Stimulation n=58 Participants Patients will be randomly assigned to the High Intensity Quell group and will receive higher intensity stimulation every day for 12 weeks. 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 Stimulation n=57 Participants Patients will be randomly assigned to the Low intensity Quell group and will receive lower intensity stimulation every day for 12 weeks. 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.
The Brief Pain Inventory Interference Scale (BPI)	5.7 score on a scale Standard Deviation 1.7	5.7 score on a scale Standard Deviation 2.2

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	High Intensity Stimulation n=58 Participants Patients will be randomly assigned to the High Intensity Quell group and will receive higher intensity stimulation every day for 12 weeks. 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 Stimulation n=57 Participants Patients will be randomly assigned to the Low intensity Quell group and will receive lower intensity stimulation every day for 12 weeks. 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.
Pain Catastrophizing Scale (PCS)	25.0 score on a scale Standard Deviation 11.6	24.8 score on a scale Standard Deviation 13.3

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	High Intensity Stimulation n=58 Participants Patients will be randomly assigned to the High Intensity Quell group and will receive higher intensity stimulation every day for 12 weeks. 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 Stimulation n=57 Participants Patients will be randomly assigned to the Low intensity Quell group and will receive lower intensity stimulation every day for 12 weeks. 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.
Pain Disability Index (PDI)	38.3 score on a scale Standard Deviation 14.6	36.3 score on a scale Standard Deviation 16.8

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	High Intensity Stimulation n=58 Participants Patients will be randomly assigned to the High Intensity Quell group and will receive higher intensity stimulation every day for 12 weeks. 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 Stimulation n=57 Participants Patients will be randomly assigned to the Low intensity Quell group and will receive lower intensity stimulation every day for 12 weeks. 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.
Hospital Anxiety and Depression Scale (HADS)	19.1 score on a scale Standard Deviation 7.7	16.9 score on a scale Standard Deviation 7.8

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	High Intensity Stimulation n=58 Participants Patients will be randomly assigned to the High Intensity Quell group and will receive higher intensity stimulation every day for 12 weeks. 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 Stimulation n=57 Participants Patients will be randomly assigned to the Low intensity Quell group and will receive lower intensity stimulation every day for 12 weeks. 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.
Pain Detect Neuropathic Pain Questionnaire (painDETECT)	16.1 score on a scale Standard Deviation 7.6	16.5 score on a scale Standard Deviation 7.4

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	High Intensity Stimulation n=58 Participants Patients will be randomly assigned to the High Intensity Quell group and will receive higher intensity stimulation every day for 12 weeks. 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 Stimulation n=57 Participants Patients will be randomly assigned to the Low intensity Quell group and will receive lower intensity stimulation every day for 12 weeks. 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.
Symptom Impact Questionnaire (SIQR)	115.8 score on a scale Standard Deviation 37.4	106.1 score on a scale Standard Deviation 38.9

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	High Intensity Stimulation n=58 Participants Patients will be randomly assigned to the High Intensity Quell group and will receive higher intensity stimulation every day for 12 weeks. 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 Stimulation n=57 Participants Patients will be randomly assigned to the Low intensity Quell group and will receive lower intensity stimulation every day for 12 weeks. 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.
Patient's Global Impression of Change (PGIC)	4.2 score on a scale Standard Deviation 1.8	4.0 score on a scale Standard Deviation 2.0

SECONDARY outcome

Timeframe: Changes from Baseline to 3-month Follow-Up

Monthly clinic and ED visits

Outcome measures

Measure	High Intensity Stimulation n=58 Participants Patients will be randomly assigned to the High Intensity Quell group and will receive higher intensity stimulation every day for 12 weeks. 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 Stimulation n=57 Participants Patients will be randomly assigned to the Low intensity Quell group and will receive lower intensity stimulation every day for 12 weeks. 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.
Healthcare Utilization Clinic visits	1.3 Number of visits Standard Deviation 1.1	1.6 Number of visits Standard Deviation 1.7
Healthcare Utilization Hospital visits	0.0 Number of visits Standard Deviation 0.2	0.1 Number of visits Standard Deviation 0.2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	High Intensity Stimulation n=58 Participants Patients will be randomly assigned to the High Intensity Quell group and will receive higher intensity stimulation every day for 12 weeks. 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 Stimulation n=57 Participants Patients will be randomly assigned to the Low intensity Quell group and will receive lower intensity stimulation every day for 12 weeks. 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.
Satisfaction and Qualitative Questions	7.6 score on a 0-10 scale Standard Deviation 2.9	7.4 score on a 0-10 scale Standard Deviation 2.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	High Intensity Stimulation n=58 Participants Patients will be randomly assigned to the High Intensity Quell group and will receive higher intensity stimulation every day for 12 weeks. 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 Stimulation n=57 Participants Patients will be randomly assigned to the Low intensity Quell group and will receive lower intensity stimulation every day for 12 weeks. 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.
Quantitative Sensory Testing (QST)	0.6 score on a scale Standard Deviation 2.0	0.0 score on a scale Standard Deviation 2.0

SECONDARY outcome

Timeframe: Changes from Baseline to 3-month Follow-Up

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

Outcome measures

Measure	High Intensity Stimulation n=58 Participants Patients will be randomly assigned to the High Intensity Quell group and will receive higher intensity stimulation every day for 12 weeks. 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 Stimulation n=57 Participants Patients will be randomly assigned to the Low intensity Quell group and will receive lower intensity stimulation every day for 12 weeks. 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.
The Brief Pain Inventory Pain Intensity Scale (BPI)	-0.5 score on a scale Standard Deviation 2.5	-1.0 score on a scale Standard Deviation 2.3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	High Intensity Stimulation n=58 Participants Patients will be randomly assigned to the High Intensity Quell group and will receive higher intensity stimulation every day for 12 weeks. 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 Stimulation n=57 Participants Patients will be randomly assigned to the Low intensity Quell group and will receive lower intensity stimulation every day for 12 weeks. 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.
MasterMyPain App	3.9 score on a scale Standard Deviation 3.2	5.1 score on a scale Standard Deviation 3.3

Adverse Events

High Intensity Stimulation

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Low Intensity Stimulation

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	High Intensity Stimulation n=58 participants at risk Patients will be randomly assigned to the High Intensity Quell group and will receive higher intensity stimulation every day for 12 weeks. 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 Stimulation n=57 participants at risk Patients will be randomly assigned to the Low intensity Quell group and will receive lower intensity stimulation every day for 12 weeks. 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.
General disorders Related	15.5% 9/58 • During the 3-month trial	10.5% 6/57 • During the 3-month trial
General disorders Unrelated	17.2% 10/58 • During the 3-month trial	14.0% 8/57 • During the 3-month trial

Additional Information

Robert Jamison

Brigham and Women's Hospital

Phone: 617-732-9046

Email: rjamison@bwh.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place