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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Subjects will receive the Quell device |
|
| Control | No Intervention | Subjects will not receive the Quell device |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quell | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months |
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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:
Exclusion Criteria:
Patients will be excluded from participation if they meet any of the following criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30636101 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental | Subjects will receive the Quell device at the baseline visit and will be asked to use the device every day for 3 months. |
| FG001 | Control | Subjects will not receive the Quell device at the baseline visit, but they will receive one after 3 months. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental | Subjects will receive the Quell device Quell |
| BG001 | Control | Subjects will not receive the Quell device |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Experimental | Subjects will receive the Quell device at the baseline visit and will be asked to use the device every day for 3 months. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Robert Jamison | Brigham and Women's Hospital | 617-732-9046 | rjamison@bwh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 1, 2016 | Apr 22, 2022 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| 3 months |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Pain Duration | Mean | Standard Deviation | years |
|
| Pain Average | 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. | Mean | Standard Deviation | units on a scale |
|
| Weight | Mean | Standard Deviation | lbs |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
Subjects will not receive the Quell device at the baseline visit, but they will receive one after 3 months. |
|
|
| Primary | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
|
|
| Primary | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
|
|
| Primary | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
|
|
| Primary | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
|
|
| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
|
|
| 0 |
| 35 |
| 0 |
| 35 |
| 0 |
| 35 |
| EG001 | Control | Subjects will not receive the Quell device at the baseline visit, but they will receive one after 3 months. | 0 | 33 | 0 | 33 | 0 | 33 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |