Efficacy of the Quell Wearable Device for Chronic Low Back Pain

• Sponsor: Brigham and Women's Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02944513
• Collaborator: (none)
• Enrollment: 68
• Arms: 2
• Actual Duration (Months): 22

Study Details

Study Description

Brief Summary

This is a 1-year trial designed to gather information about the use of the Quell for persons with chronic musculoskeletal low back pain.

Condition or Disease	Intervention/Treatment	Phase
Low Back Pain	Device: Quell	N/A

Detailed Description

Research Objectives: This is a 1-year trial designed to gather information about the use of the Quell for persons with chronic musculoskeletal low back pain. The investigators hypothesize that those assigned to using the device will report reduced back pain compared with those in the control condition; with those using the device also showing improvement in sleep, mood, and level of activity. The investigators hypothesize that frequency of using the Quell (increased tolerability and adherence) will be correlated with greater reduction in pain. The investigators hypothesize that the device will be safe to use and will demonstrate a reduction in healthcare utilization (reduced clinic and Emergency Department visits). Finally, based on preliminary analyses limited by few subject numbers, the investigators will investigate whether certain individuals report greater benefit from using the Quell than others and, in particular, would predict that those with more intense and longer duration of pain will demonstrate most benefit.

Study Design

• Study Type: Interventional
• Actual Enrollment: 68 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Efficacy of the Quell Wearable Device for Chronic Low Back Pain
• Actual Study Start Date: Oct 1, 2016
• Actual Primary Completion Date: Aug 1, 2018
• Actual Study Completion Date: Aug 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental Subjects will receive the Quell device	Device: Quell
No Intervention: Control Subjects will not receive the Quell device

Outcome Measures

Primary Outcome Measures

1. Pain Intensity (Average) [3 months]

   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.

2. Average Pain Interference [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.

3. Pain Disability Index [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.

4. Pain Catastrophizing Scale [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.

5. Hospital Anxiety and Depression Scale Total Score [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.

Secondary Outcome Measures

1. Post-study Helpfulness Questionnaire [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• All participants will be adults age 21 or older and diagnosed with axial musculoskeletal back pain without radiculopathy.

• Patients will be invited to participate if they own a smart phone (iPhone or Android device) and are able to download the pain app and the Quell Relief program app onto their device.

• Patients will also be included if they:

1. have chronic pain for > 3 months' duration

2. average 4 or greater on a pain intensity scale of 0 to 10

3. are able to speak and understand English.

Exclusion Criteria:

• Patients will be excluded from participation if they meet any of the following criteria:

1. diagnosis of cancer or any other malignant disease

2. acute osteomyelitis or acute bone disease

3. present or past Diagnostic and Statistical Manual-V diagnosis of schizophrenia, delusional disorder, psychotic disorder, or dissociative disorder that would be judged to interfere with study participation

4. pregnancy

5. any clinically unstable systemic illness judged to interfere with treatment

6. a pain condition requiring urgent surgery

7. an active substance use disorder, such as cocaine or IV heroin use, (positive on the Mini International Neuropsychiatric Interview; M.I.N.I. v.5.0) that would interfere with study participation

8. any prescription opioid use for pain

9. have an implanted cardiac pacemaker, defibrillator, or other implanted device. All subjects will be asked to not change their treatment during the study period.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Brigham and Women's Hospital

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 1, 2016

More Information

Publications

None provided.

• Responsible Party: Robert N. Jamison, PhD, Professor, Brigham and Women's Hospital
• ClinicalTrials.gov Identifier: NCT02944513
• Other Study ID Numbers: 2016P002172
• First Posted: Oct 26, 2016
• Last Update Posted: Apr 25, 2022
• Last Verified: Apr 1, 2022

• Additional relevant MeSH terms: Back Pain; Low Back Pain

Study Results

Participant Flow

Arm/Group Title	Experimental	Control
Arm/Group Description	Subjects will receive the Quell device at the baseline visit and will be asked to use the device every day for 3 months.	Subjects will not receive the Quell device at the baseline visit, but they will receive one after 3 months.
Period Title: Overall Study
STARTED	35	33
COMPLETED	31	32
NOT COMPLETED	4	1

Baseline Characteristics

Arm/Group Title	Experimental	Control	Total
Arm/Group Description	Subjects will receive the Quell device Quell	Subjects will not receive the Quell device	Total of all reporting groups
Overall Participants	35	33	68
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	48 (14)	45 (11)	47 (13)
Sex: Female, Male (Count of Participants)
Female	18 51.4%	23 69.7%	41 60.3%
Male	17 48.6%	10 30.3%	27 39.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 2.9%	2 6.1%	3 4.4%
Not Hispanic or Latino	34 97.1%	31 93.9%	65 95.6%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 2.9%	0 0%	1 1.5%
Asian	2 5.7%	1 3%	3 4.4%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	2 5.7%	5 15.2%	7 10.3%
White	28 80%	25 75.8%	53 77.9%
More than one race	1 2.9%	0 0%	1 1.5%
Unknown or Not Reported	1 2.9%	2 6.1%	3 4.4%
Pain Duration (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	12.5 (10.6)	13.9 (13.4)	13.2 (11.9)
Pain Average (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	5.2 (1.7)	5.7 (1.4)	5.5 (1.6)
Weight (lbs) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [lbs]	186.5 (60.0)	175.0 (51.9)	182.7 (51.4)
BMI (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	30.2 (6.0)	30.7 (8.5)	30.4 (7.2)

Outcome Measures

1. Primary Outcome

Title	Pain Intensity (Average)
Description	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.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Experimental	Control
Arm/Group Description	Subjects will receive the Quell device at the baseline visit and will be asked to use the device every day for 3 months.	Subjects will not receive the Quell device at the baseline visit, but they will receive one after 3 months.
Measure Participants	29	31
Mean (Standard Deviation) [score on a scale]	4.0 (2.5)	5.7 (1.9)

2. Primary Outcome

Title	Average Pain Interference
Description	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.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Experimental	Control
Arm/Group Description	Subjects will receive the Quell device at the baseline visit and will be asked to use the device every day for 3 months.	Subjects will not receive the Quell device at the baseline visit, but they will receive one after 3 months.
Measure Participants	29	31
Mean (Standard Deviation) [score on a scale]	3.2 (3.0)	5.4 (2.3)

3. Primary Outcome

Title	Pain Disability Index
Description	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.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Experimental	Control
Arm/Group Description	Subjects will receive the Quell device at the baseline visit and will be asked to use the device every day for 3 months.	Subjects will not receive the Quell device at the baseline visit, but they will receive one after 3 months.
Measure Participants	29	31
Mean (Standard Deviation) [score on a scale]	26.3 (19.0)	34.9 (16.7)

4. Primary Outcome

Title	Pain Catastrophizing Scale
Description	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.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Experimental	Control
Arm/Group Description	Subjects will receive the Quell device at the baseline visit and will be asked to use the device every day for 3 months.	Subjects will not receive the Quell device at the baseline visit, but they will receive one after 3 months.
Measure Participants	29	31
Mean (Standard Deviation) [score on a scale]	13.9 (12.6)	25.1 (13.8)

5. Primary Outcome

Title	Hospital Anxiety and Depression Scale Total Score
Description	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.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Experimental	Control
Arm/Group Description	Subjects will receive the Quell device at the baseline visit and will be asked to use the device every day for 3 months.	Subjects will not receive the Quell device at the baseline visit, but they will receive one after 3 months.
Measure Participants	29	31
Mean (Standard Deviation) [score on a scale]	15.2 (8.8)	16.6 (7.6)

6. Secondary Outcome

Title	Post-study Helpfulness Questionnaire
Description	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.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Experimental	Control
Arm/Group Description	Subjects will receive the Quell device at the baseline visit and will be asked to use the device every day for 3 months.	Subjects will not receive the Quell device at the baseline visit, but they will receive one after 3 months.
Measure Participants	29	31
Mean (Standard Deviation) [score on a scale]	4.7 (3.4)	NA (NA)

Adverse Events

Time Frame	3 months
Arm/Group Title	Experimental		Control
Arm/Group Description	Subjects will receive the Quell device at the baseline visit and will be asked to use the device every day for 3 months.		Subjects will not receive the Quell device at the baseline visit, but they will receive one after 3 months.
All Cause Mortality
	Experimental		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/35 (0%)		0/33 (0%)
Serious Adverse Events
	Experimental		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/35 (0%)		0/33 (0%)
Other (Not Including Serious) Adverse Events
	Experimental		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/35 (0%)		0/33 (0%)

Limitations/Caveats

followed for only three months no active comparator treatment in the control group hard to know how other treatments or environmental factors might have affected the outcome of this study

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.