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Efficacy of the Quell Wearable Device for Chronic Low Back Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02944513
Recruitment Status : Completed
First Posted : October 26, 2016
Results First Posted : February 26, 2019
Last Update Posted : April 25, 2022
Sponsor:
Information provided by (Responsible Party):
Robert N. Jamison, PhD, Brigham and Women's Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Low Back Pain
Intervention Device: Quell
Enrollment 68
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Experimental Control
Hide 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
Reason Not Completed
Withdrawal by Subject             4             1
Arm/Group Title Experimental Control Total
Hide Arm/Group Description

Subjects will receive the Quell device

Quell

 Subjects will not receive the Quell device Total of all reporting groups
Overall Number of Baseline Participants 35 33 68
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 35 participants 33 participants 68 participants
48  (14) 45  (11) 47  (13)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 33 participants 68 participants
Female
18
  51.4%
23
  69.7%
41
  60.3%
Male
17
  48.6%
10
  30.3%
27
  39.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 33 participants 68 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%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 33 participants 68 participants
American Indian or Alaska Native
1
   2.9%
0
   0.0%
1
   1.5%
Asian
2
   5.7%
1
   3.0%
3
   4.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
   5.7%
5
  15.2%
7
  10.3%
White
28
  80.0%
25
  75.8%
53
  77.9%
More than one race
1
   2.9%
0
   0.0%
1
   1.5%
Unknown or Not Reported
1
   2.9%
2
   6.1%
3
   4.4%
Pain Duration  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 35 participants 33 participants 68 participants
12.5  (10.6) 13.9  (13.4) 13.2  (11.9)
Pain Average   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 35 participants 33 participants 68 participants
5.2  (1.7) 5.7  (1.4) 5.5  (1.6)
[1]
Measure Description: Average pain score on a scale of 0-10, where 0 is no pain and 10 is worst possible pain. Higher value means worse pain representing a worse outcome.
Weight  
Mean (Standard Deviation)
Unit of measure:  Lbs
Number Analyzed 35 participants 33 participants 68 participants
186.5  (60.0) 175.0  (51.9) 182.7  (51.4)
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 35 participants 33 participants 68 participants
30.2  (6.0) 30.7  (8.5) 30.4  (7.2)
1.Primary Outcome
Title Pain Intensity (Average)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 29 31
Mean (Standard Deviation)
Unit of Measure: score on a scale
4.0  (2.5) 5.7  (1.9)
2.Primary Outcome
Title Average Pain Interference
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 29 31
Mean (Standard Deviation)
Unit of Measure: score on a scale
3.2  (3.0) 5.4  (2.3)
3.Primary Outcome
Title Pain Disability Index
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 29 31
Mean (Standard Deviation)
Unit of Measure: score on a scale
26.3  (19.0) 34.9  (16.7)
4.Primary Outcome
Title Pain Catastrophizing Scale
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 29 31
Mean (Standard Deviation)
Unit of Measure: score on a scale
13.9  (12.6) 25.1  (13.8)
5.Primary Outcome
Title Hospital Anxiety and Depression Scale Total Score
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 29 31
Mean (Standard Deviation)
Unit of Measure: score on a scale
15.2  (8.8) 16.6  (7.6)
6.Secondary Outcome
Title Post-study Helpfulness Questionnaire
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 29 31
Mean (Standard Deviation)
Unit of Measure: score on a scale
4.7  (3.4) NA [1]   (NA)
[1]
For the control group, the subjects received the device after they completed study, so they could not complete the 3-month helpfulness questionnaire.
Time Frame 3 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Experimental Control
Hide 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 (%) Affected / at Risk (%)
Total   0/35 (0.00%)   0/33 (0.00%) 
Hide Serious Adverse Events
Experimental Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/35 (0.00%)   0/33 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Experimental Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/35 (0.00%)   0/33 (0.00%) 
  1. followed for only three months
  2. no active comparator treatment in the control group
  3. hard to know how other treatments or environmental factors might have affected the outcome of this study
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Robert Jamison
Organization: Brigham and Women's Hospital
Phone: 617-732-9046
EMail: rjamison@bwh.harvard.edu
Publications of Results:
Jamison RN, Wan L, Edwards RR, Mei A, Ross EL. Outcome of a High-Frequency Transcutaneous Electrical Nerve Stimulator (hfTENS) Device for Low Back Pain: A Randomized Controlled Trial. Pain Pract. 2019 Jun;19(5):466-475. doi: 10.1111/papr.12764. Epub 2019 Feb 4.
Layout table for additonal information
Responsible Party: Robert N. Jamison, PhD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT02944513    
Other Study ID Numbers: 2016P002172
First Submitted: October 24, 2016
First Posted: October 26, 2016
Results First Submitted: January 15, 2019
Results First Posted: February 26, 2019
Last Update Posted: April 25, 2022