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| Name | Class |
|---|---|
| NeuroMetrix, Inc. | INDUSTRY |
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This study will examine the pain-relieving effects of a transcutaneous electrical nerve stimulator device called a Quell for persons with multiple chronic overlapping pain conditions.
This study will examine the pain-relieving effects of a transcutaneous electrical nerve stimulator device called a Quell for persons with multiple chronic overlapping pain conditions. Participants will attend two quantitative sensory testing visits in order to determine their level of pain sensitivity, one at the beginning of the study and the second at the 3-month Follow-up session. Participants will be asked to test out the Quell device to check for sensation tolerance, and will then be randomized into one of the two treatment groups: the High Intensity Quell group or the Low Intensity Quell group. Participants will be asked to wear the device for at least 3 hours every day and to complete daily assessments, along with a total of three sets of questionnaires: one at the start of the study, the second 6 weeks from the date of consent, and the third 3 months after the date of consent. A member of the research staff will call participants once a week for a brief phone interview throughout the study. Participants will be in this study for 3 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Intensity Stimulation | Active Comparator | Patients will be randomly assigned to the High Intensity Quell group and will receive higher intensity stimulation every day for 12 weeks. |
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| Low Intensity Stimulation | Sham Comparator | Patients will be randomly assigned to the Low intensity Quell group and will receive lower intensity stimulation every day for 12 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Intensity Quell | Device | Participants will receive 1 hour of continuous stimulation during each therapy session. Subjects are asked to complete a minimum of 3 sessions per day. |
| Measure | Description | Time Frame |
|---|---|---|
| The Brief Pain Inventory Interference Scale (BPI) | This is a validated measure of combined activity interference on a numerical scale of 0-10, with higher scores representing greater activity interference. We collected ratings on how much pain interfered over the past 24 hours with 1) General activity, 2) Mood, 3) Walking ability, 4) Normal work, 5) Relations with other people, 6) Sleep, and 7) Enjoyment of life on a scale of 0=does not interfere to 10=completely interferes. The table represents combined mean scores between groups. These ratings were collected at 3 months after start of the study. | Between group differences at 3-months |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Catastrophizing Scale (PCS) | Measures thoughts and feelings when patient is experiencing pain on a 13-item scale ranging from 0-52 with higher scores meaning a worse outcome and higher catastrophizing | Changes from Baseline to 3-month Follow-Up |
| Pain Disability Index (PDI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert N. Jamison, Ph.D. | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital Pain Management Center | Chestnut Hill | Massachusetts | 02467 | United States |
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| Label | URL |
|---|---|
| Link to rally website to Quell COPCs | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | High Intensity Stimulation | Patients will be randomly assigned to the High Intensity Quell group and will receive higher intensity stimulation every day for 12 weeks. High Intensity Quell: Participants will receive 1 hour of continuous stimulation during each therapy session. Subjects are asked to complete a minimum of 3 sessions per day. |
| FG001 | Low Intensity Stimulation | Patients will be randomly assigned to the Low intensity Quell group and will receive lower intensity stimulation every day for 12 weeks. Low Intensity Quell: Participants will receive only three 2-minute periods of stimulation (at 0, 28, 58 minutes) during each 60-minute therapeutic session. Subjects are asked to complete a minimum of 3 sessions per day. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | High Intensity Stimulation | Patients will be randomly assigned to the High Intensity Quell group and will receive higher intensity stimulation every day for 12 weeks. High Intensity Quell: Participants will receive 1 hour of continuous stimulation during each therapy session. Subjects are asked to complete a minimum of 3 sessions per day. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | The Brief Pain Inventory Interference Scale (BPI) | This is a validated measure of combined activity interference on a numerical scale of 0-10, with higher scores representing greater activity interference. We collected ratings on how much pain interfered over the past 24 hours with 1) General activity, 2) Mood, 3) Walking ability, 4) Normal work, 5) Relations with other people, 6) Sleep, and 7) Enjoyment of life on a scale of 0=does not interfere to 10=completely interferes. The table represents combined mean scores between groups. These ratings were collected at 3 months after start of the study. | Posted | Mean | Standard Deviation | score on a scale | Between group differences at 3-months |
|
During the 3-month trial
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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 | High Intensity Stimulation | Patients will be randomly assigned to the High Intensity Quell group and will receive higher intensity stimulation every day for 12 weeks. High Intensity Quell: Participants will receive 1 hour of continuous stimulation during each therapy session. Subjects are asked to complete a minimum of 3 sessions per day. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Related | General disorders | Non-systematic Assessment |
There were several limitations. The study included a limited number of subjects. Subjects were only followed for 3 months. The subjects had other medical comorbidities.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| 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 | Sep 7, 2022 | Dec 5, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Participants will be equally randomized to one of the two treatment groups: the High Intensity Quell group or the Low Intensity Quell group. All groups will receive the same questionnaires and undergo quantitative sensory testing.
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Neither the principal investigator, the co-investigators, the research assistant, or the subjects will know if they are given the high intensity Quell device or the low intensity Quell device.
| Low Intensity Quell | Device | Participants will receive only three 2-minute periods of stimulation (at 0, 28, 58 minutes) during each 60-minute therapeutic session. Subjects are asked to complete a minimum of 3 sessions per day. |
|
Rating scales designed to measure levels of pain disability, or the degree to which pain is preventing a patient from doing what they normally would be doing, or doing it as well as they normally would on a 7-item scale of 0-10 ranging from 0-70 with higher scores meaning a worse outcome |
| Changes from Baseline to 3-month Follow-Up |
| Hospital Anxiety and Depression Scale (HADS) | Measures mood on a 14-item scale ranging from 0 to 42 with higher scores meaning a worse outcome | Changes from Baseline to 3-month Follow-Up |
| Pain Detect Neuropathic Pain Questionnaire (painDETECT) | Measures the presence of neuropathic pain on a scale ranging from 1 to 38 on ratings of 'never to very strongly' with higher scores meaning a worse outcome | Changes from Baseline to 3-month Follow-Up |
| Symptom Impact Questionnaire (SIQR) | Measures 20 pain symptoms and function on a scale of 0-10 with scores ranging from 0 to 200 with higher scores meaning a worse outcome | Changes from Baseline to 3-month Follow-Up |
| Patient's Global Impression of Change (PGIC) | Measures the subject's overall belief about the efficacy of treatment on a 7-point categorical verbal rating scale. The scale ranges from (1) "no change or condition has gotten worse" to (7) "a great deal better and a considerable improvement that has made all the difference. | Changes from Baseline to 3-month Follow-Up |
| Healthcare Utilization | Monthly clinic and ED visits | Changes from Baseline to 3-month Follow-Up |
| Satisfaction and Qualitative Questions | A satisfaction questionnaire was developed for this study specifically related to use of the pain management device (Quell) and use of the study app. Ten items related to use of the device and five items were related to use of the smartphone study app all rated on a scale of 0 (worse) to 10 (better). Below are group differences on "How willing would you be to using the Quell in the future?" rated from 0=Not at all willing to 10=Very willing. This questionnaire was only administered at the end of the trial. | 3-month Follow-up |
| Quantitative Sensory Testing (QST) | Set of psychophysical methods used to quantify somatosensory function. Combined hypersensitivity measure that measures responses to repeated touch, mechanical/pressure pain assessment, and cold pain assessment. Overall sensitivity based on z scores categorized into high and low sensitivity. Higher scores represent less sensitivity. The mean score is 0. | Changes from Baseline to 3-month Follow-Up |
| The Brief Pain Inventory Pain Intensity Scale (BPI) | Average pain on a scale of 0-10 with higher scores meaning a worse outcome | Changes from Baseline to 3-month Follow-Up |
| MasterMyPain App | Daily ratings of pain related factors on smartphone pain app on a scale of 0-10 with higher scores meaning a worse outcome. Multiple daily assessments were averaged for mean and standard deviation scores. | Daily ratings over 3-months |
| BG001 |
| Low Intensity Stimulation |
Patients will be randomly assigned to the Low intensity Quell group and will receive lower intensity stimulation every day for 12 weeks. Low Intensity Quell: Participants will receive only three 2-minute periods of stimulation (at 0, 28, 58 minutes) during each 60-minute therapeutic session. Subjects are asked to complete a minimum of 3 sessions per day. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Low Intensity Stimulation | Patients will be randomly assigned to the Low intensity Quell group and will receive lower intensity stimulation every day for 12 weeks. Low Intensity Quell: Participants will receive only three 2-minute periods of stimulation (at 0, 28, 58 minutes) during each 60-minute therapeutic session. Subjects are asked to complete a minimum of 3 sessions per day. |
|
|
| Secondary | Pain Catastrophizing Scale (PCS) | Measures thoughts and feelings when patient is experiencing pain on a 13-item scale ranging from 0-52 with higher scores meaning a worse outcome and higher catastrophizing | Posted | Mean | Standard Deviation | score on a scale | Changes from Baseline to 3-month Follow-Up |
|
|
|
| Secondary | Pain Disability Index (PDI) | Rating scales designed to measure levels of pain disability, or the degree to which pain is preventing a patient from doing what they normally would be doing, or doing it as well as they normally would on a 7-item scale of 0-10 ranging from 0-70 with higher scores meaning a worse outcome | Posted | Mean | Standard Deviation | score on a scale | Changes from Baseline to 3-month Follow-Up |
|
|
|
| Secondary | Hospital Anxiety and Depression Scale (HADS) | Measures mood on a 14-item scale ranging from 0 to 42 with higher scores meaning a worse outcome | Posted | Mean | Standard Deviation | score on a scale | Changes from Baseline to 3-month Follow-Up |
|
|
|
| Secondary | Pain Detect Neuropathic Pain Questionnaire (painDETECT) | Measures the presence of neuropathic pain on a scale ranging from 1 to 38 on ratings of 'never to very strongly' with higher scores meaning a worse outcome | Posted | Mean | Standard Deviation | score on a scale | Changes from Baseline to 3-month Follow-Up |
|
|
|
| Secondary | Symptom Impact Questionnaire (SIQR) | Measures 20 pain symptoms and function on a scale of 0-10 with scores ranging from 0 to 200 with higher scores meaning a worse outcome | Posted | Mean | Standard Deviation | score on a scale | Changes from Baseline to 3-month Follow-Up |
|
|
|
| Secondary | Patient's Global Impression of Change (PGIC) | Measures the subject's overall belief about the efficacy of treatment on a 7-point categorical verbal rating scale. The scale ranges from (1) "no change or condition has gotten worse" to (7) "a great deal better and a considerable improvement that has made all the difference. | Posted | Mean | Standard Deviation | score on a scale | Changes from Baseline to 3-month Follow-Up |
|
|
|
| Secondary | Healthcare Utilization | Monthly clinic and ED visits | Posted | Mean | Standard Deviation | Number of visits | Changes from Baseline to 3-month Follow-Up |
|
|
|
| Secondary | Satisfaction and Qualitative Questions | A satisfaction questionnaire was developed for this study specifically related to use of the pain management device (Quell) and use of the study app. Ten items related to use of the device and five items were related to use of the smartphone study app all rated on a scale of 0 (worse) to 10 (better). Below are group differences on "How willing would you be to using the Quell in the future?" rated from 0=Not at all willing to 10=Very willing. This questionnaire was only administered at the end of the trial. | Posted | Mean | Standard Deviation | score on a 0-10 scale | 3-month Follow-up |
|
|
|
| Secondary | Quantitative Sensory Testing (QST) | Set of psychophysical methods used to quantify somatosensory function. Combined hypersensitivity measure that measures responses to repeated touch, mechanical/pressure pain assessment, and cold pain assessment. Overall sensitivity based on z scores categorized into high and low sensitivity. Higher scores represent less sensitivity. The mean score is 0. | Posted | Mean | Standard Deviation | score on a scale | Changes from Baseline to 3-month Follow-Up |
|
|
|
| Secondary | The Brief Pain Inventory Pain Intensity Scale (BPI) | Average pain on a scale of 0-10 with higher scores meaning a worse outcome | Posted | Mean | Standard Deviation | score on a scale | Changes from Baseline to 3-month Follow-Up |
|
|
|
| Secondary | MasterMyPain App | Daily ratings of pain related factors on smartphone pain app on a scale of 0-10 with higher scores meaning a worse outcome. Multiple daily assessments were averaged for mean and standard deviation scores. | Posted | Mean | Standard Deviation | score on a scale | Daily ratings over 3-months |
|
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| 0 |
| 58 |
| 0 |
| 58 |
| 19 |
| 58 |
| EG001 | Low Intensity Stimulation | Patients will be randomly assigned to the Low intensity Quell group and will receive lower intensity stimulation every day for 12 weeks. Low Intensity Quell: Participants will receive only three 2-minute periods of stimulation (at 0, 28, 58 minutes) during each 60-minute therapeutic session. Subjects are asked to complete a minimum of 3 sessions per day. | 0 | 57 | 0 | 57 | 14 | 57 |
| Unrelated | General disorders | Non-systematic Assessment |
|
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| D007154 | Immune System Diseases |