Trial Outcomes & Findings for Efficacy of the Quell Wearable Device for Chronic Low Back Pain (NCT NCT02944513)

Last Updated: 2022-04-25

Results Overview

Rate average pain intensity using visual analog scale on a scale of 0-10, where 0 is no pain and 10 is worst possible pain. Higher scores mean a worse outcome.

Recruitment status

COMPLETED

Study phase

Target enrollment

68 participants

Primary outcome timeframe

3 months

Results posted on

2022-04-25

Participant Flow

Participant milestones

Participant milestones
Measure	Experimental Subjects will receive the Quell device at the baseline visit and will be asked to use the device every day for 3 months.	Control Subjects will not receive the Quell device at the baseline visit, but they will receive one after 3 months.
Overall Study STARTED	35	33
Overall Study COMPLETED	31	32
Overall Study NOT COMPLETED	4	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Experimental Subjects will receive the Quell device at the baseline visit and will be asked to use the device every day for 3 months.	Control Subjects will not receive the Quell device at the baseline visit, but they will receive one after 3 months.
Overall Study Withdrawal by Subject	4	1

Baseline Characteristics

Efficacy of the Quell Wearable Device for Chronic Low Back Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental n=35 Participants Subjects will receive the Quell device Quell	Control n=33 Participants Subjects will not receive the Quell device	Total n=68 Participants Total of all reporting groups
Age, Continuous	48 years STANDARD_DEVIATION 14 • n=5 Participants	45 years STANDARD_DEVIATION 11 • n=7 Participants	47 years STANDARD_DEVIATION 13 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	23 Participants n=7 Participants	41 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	10 Participants n=7 Participants	27 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	34 Participants n=5 Participants	31 Participants n=7 Participants	65 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 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	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) White	28 Participants n=5 Participants	25 Participants n=7 Participants	53 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Pain Duration	12.5 years STANDARD_DEVIATION 10.6 • n=5 Participants	13.9 years STANDARD_DEVIATION 13.4 • n=7 Participants	13.2 years STANDARD_DEVIATION 11.9 • n=5 Participants
Pain Average	5.2 units on a scale STANDARD_DEVIATION 1.7 • n=5 Participants	5.7 units on a scale STANDARD_DEVIATION 1.4 • n=7 Participants	5.5 units on a scale STANDARD_DEVIATION 1.6 • n=5 Participants
Weight	186.5 lbs STANDARD_DEVIATION 60.0 • n=5 Participants	175.0 lbs STANDARD_DEVIATION 51.9 • n=7 Participants	182.7 lbs STANDARD_DEVIATION 51.4 • n=5 Participants
BMI	30.2 kg/m^2 STANDARD_DEVIATION 6.0 • n=5 Participants	30.7 kg/m^2 STANDARD_DEVIATION 8.5 • n=7 Participants	30.4 kg/m^2 STANDARD_DEVIATION 7.2 • n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: For the experimental group, 35 subjects were consented, 4 subjects dropped out, 2 subjects did not complete the 3-month questionnaire, so 29 subjects were analyzed. For the control group, 33 subjects were consented, 1 subject dropped out, 1 subject did not complete the 3-month questionnaire, so 31 subjects were analyzed.

Rate average pain intensity using visual analog scale on a scale of 0-10, where 0 is no pain and 10 is worst possible pain. Higher scores mean a worse outcome.

Outcome measures

Outcome measures
Measure	Experimental n=29 Participants Subjects will receive the Quell device at the baseline visit and will be asked to use the device every day for 3 months.	Control n=31 Participants Subjects will not receive the Quell device at the baseline visit, but they will receive one after 3 months.
Pain Intensity (Average)	4.0 score on a scale Standard Deviation 2.5	5.7 score on a scale Standard Deviation 1.9

PRIMARY outcome

Timeframe: 3 months

This measures the average pain interference with general activity, mood, walking ability, normal work, relations with others, sleep and enjoyment of life using visual analogue scale. On a scale of 0-10, 0 is no interference and 10 is extreme interference. Higher scores mean worse outcome.

Outcome measures

Outcome measures
Measure	Experimental n=29 Participants Subjects will receive the Quell device at the baseline visit and will be asked to use the device every day for 3 months.	Control n=31 Participants Subjects will not receive the Quell device at the baseline visit, but they will receive one after 3 months.
Average Pain Interference	3.2 score on a scale Standard Deviation 3.0	5.4 score on a scale Standard Deviation 2.3

PRIMARY outcome

Timeframe: 3 months

The Pain Disability Index (PDI) a simple and rapid instrument for measuring the impact that pain has on the ability of a person to participate in essential life activities. For each of the 7 categories of life activity listed, a score of 0 means no disability at all, and a score of 10 signifies that all of the activities in which you would normally be involved have been totally disrupted or prevented by your pain. The minimal index is 0 and maximal index is 70. The higher the index the greater the person's disability due to pain meaning a worse outcome.

Outcome measures

Outcome measures
Measure	Experimental n=29 Participants Subjects will receive the Quell device at the baseline visit and will be asked to use the device every day for 3 months.	Control n=31 Participants Subjects will not receive the Quell device at the baseline visit, but they will receive one after 3 months.
Pain Disability Index	26.3 score on a scale Standard Deviation 19.0	34.9 score on a scale Standard Deviation 16.7

PRIMARY outcome

Timeframe: 3 months

Pain Catastrophizing Scale (PCS) has thirteen statements describing different thoughts and feelings that may be associated with pain. Using a 5-point scale from 0 (Not at all) to 4 (all the time), people indicate the degree to which they have these thoughts and feelings when they are experiencing pain. The sum has a minimum of 0 and a maximum of 52. Higher scores mean high levels of pain catastrophizing and worse outcome.

Outcome measures

Outcome measures
Measure	Experimental n=29 Participants Subjects will receive the Quell device at the baseline visit and will be asked to use the device every day for 3 months.	Control n=31 Participants Subjects will not receive the Quell device at the baseline visit, but they will receive one after 3 months.
Pain Catastrophizing Scale	13.9 score on a scale Standard Deviation 12.6	25.1 score on a scale Standard Deviation 13.8

PRIMARY outcome

Timeframe: 3 months

Hospital Anxiety and Depression Scale (HADS) is commonly used to determine the levels of anxiety and depression that a person is experiencing. The HADS is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. This outcome is a total score, which was calculated by adding the anxiety score and the depression score. Total score ranges from 0-42, with higher scores indicating a worse outcome.

Outcome measures

Outcome measures
Measure	Experimental n=29 Participants Subjects will receive the Quell device at the baseline visit and will be asked to use the device every day for 3 months.	Control n=31 Participants Subjects will not receive the Quell device at the baseline visit, but they will receive one after 3 months.
Hospital Anxiety and Depression Scale Total Score	15.2 score on a scale Standard Deviation 8.8	16.6 score on a scale Standard Deviation 7.6

SECONDARY outcome

Timeframe: 3 months

The questionnaire asked the participants to rate how helpful was the device for the low back pain on a scale of 0-10. 0 is not helpful at all and 10 is very helpful. Higher value means better outcome.

Outcome measures

Outcome measures
Measure	Experimental n=29 Participants Subjects will receive the Quell device at the baseline visit and will be asked to use the device every day for 3 months.	Control n=31 Participants Subjects will not receive the Quell device at the baseline visit, but they will receive one after 3 months.
Post-study Helpfulness Questionnaire	4.7 score on a scale Standard Deviation 3.4	NA score on a scale Standard Deviation NA For the control group, the subjects received the device after they completed study, so they could not complete the 3-month helpfulness questionnaire.

Adverse Events

Experimental

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Robert Jamison

Brigham and Women's Hospital

Phone: 617-732-9046

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place