An interventional study of Quell in Low Back Pain, sponsored by Brigham and Women's Hospital. Completed. Open to participants aged 21 Years to 99 Years. Per ClinicalTrials.gov, last updated 2022-04-25.
Sponsored by Brigham and Women's Hospital · Not applicable, Interventional, and Treatment
This is a 1-year trial designed to gather information about the use of the Quell for persons with chronic musculoskeletal low back pain.
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.
2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.
This study's enrollment of 68 is above the median of 60 across 1,941 interventional studies indexed under Back Pain.
Browse Back Pain studies →Brigham and Women's Hospital is the lead sponsor of 1,236 studies on the registry; 224 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 64 (55%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients will also be included if they:
Exclusion Criteria:
Patients will be excluded from participation if they meet any of the following criteria:
Subjects will receive the Quell device
Device: Quell
Subjects will not receive the Quell device
Pain Intensity (Average)
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
Average Pain Interference
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
Pain Disability Index
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
Pain Catastrophizing Scale
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
Hospital Anxiety and Depression Scale Total Score
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
Post-study Helpfulness Questionnaire
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
| Milestone | Experimental | Control |
|---|---|---|
| Started | 35 | 33 |
| Completed | 31 | 32 |
| Not completed | 4 | 1 |
| Withdrew: Withdrawal by subject | 4 | 1 |
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.
| score on a scale | Experimental | Control |
|---|---|---|
| Pain Intensity (Average) | 4.0 ± 2.5 | 5.7 ± 1.9 |
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.
| score on a scale | Experimental | Control |
|---|---|---|
| Average Pain Interference | 3.2 ± 3.0 | 5.4 ± 2.3 |
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.
| score on a scale | Experimental | Control |
|---|---|---|
| Pain Disability Index | 26.3 ± 19.0 | 34.9 ± 16.7 |
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.
| score on a scale | Experimental | Control |
|---|---|---|
| Pain Catastrophizing Scale | 13.9 ± 12.6 | 25.1 ± 13.8 |
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.
| score on a scale | Experimental | Control |
|---|---|---|
| Hospital Anxiety and Depression Scale Total Score | 15.2 ± 8.8 | 16.6 ± 7.6 |
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.
| score on a scale | Experimental | Control |
|---|---|---|
| Post-study Helpfulness Questionnaire | 4.7 ± 3.4 | NA ± NA |
Collected over 3 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Experimental | 0/35 (0%) | 0/35 (0%) | 0/35 (0%) |
| Control | 0/33 (0%) | 0/33 (0%) | 0/33 (0%) |
| Age, Continuous(years) | Experimental | Control | Total |
|---|---|---|---|
| Mean | 48 ± 14 | 45 ± 11 | 47 ± 13 |
| Sex: Female, Male(Participants) | Experimental | Control | Total |
|---|---|---|---|
| Female | 18 | 23 | 41 |
| Male | 17 | 10 | 27 |
| Ethnicity (NIH/OMB)(Participants) | Experimental | Control | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 2 | 3 |
| Not Hispanic or Latino | 34 | 31 | 65 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Experimental | Control | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 2 | 1 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 5 | 7 |
| White | 28 | 25 | 53 |
| More than one race | 1 | 0 | 1 |
| Unknown or Not Reported | 1 | 2 | 3 |
| Pain Duration(years) | Experimental | Control | Total |
|---|---|---|---|
| Mean | 12.5 ± 10.6 | 13.9 ± 13.4 | 13.2 ± 11.9 |
| Pain Average(units on a scale) | Experimental | Control | Total |
|---|---|---|---|
| Mean | 5.2 ± 1.7 | 5.7 ± 1.4 | 5.5 ± 1.6 |
| Weight(lbs) | Experimental | Control | Total |
|---|---|---|---|
| Mean | 186.5 ± 60.0 | 175.0 ± 51.9 | 182.7 ± 51.4 |
| BMI(kg/m^2) | Experimental | Control | Total |
|---|---|---|---|
| Mean | 30.2 ± 6.0 | 30.7 ± 8.5 | 30.4 ± 7.2 |
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Brigham and Women's Hospital