Adults 21 and Older, Chronic Pain, Hypersensitivity, Multiple Chronic Overlapping Pain Conditions
Conditions
Keywords
Multiple Chronic Overlapping Pain Conditions, Adults 21 and older
Brief summary
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.
Detailed description
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.
Interventions
DEVICEHigh 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.
DEVICELow 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.
Sponsors
NeuroMetrix, Inc.
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
21 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Ages 21 and older * Pain duration \> 3 months * Diagnosed by physician with multiple chronic pain conditions * Have chronic pain related to multiple chronic pain diagnoses (headaches, joint pain, back pain, or any of the other COPCs) * Average 4 or greater on pain intensity scale of 0 to 10 * Pain is not accounted for by any other progressive disease (e.g., cancer, MS) * Meets sensory hypersensitivity cutoffs based on QST-assessed evidence * Own a smartphone (iPhone or Android device) and can download the pain app (MasterMyPain) and the Quell Relief mobile app onto their device * Able to speak and understand English
Exclusion criteria
* Diagnosis of cancer or any other malignant disease * Acute osteomyelitis or acute bone disease * Present of past DSM-V diagnosis of schizophrenia, delusional disorder, psychotic disorder, or dissociative disorder that would be judged to interfere with study participation * Pregnancy * Any clinically unstable systemic illness judged to interfere with treatment * A pain condition requiring urgent surgery * An active substance use disorder, such as cocaine or IV heroin use that would interfere with study participation * Have an implanted cardiac pacemaker, defibrillator, or other implanted device. * Reynaud's syndrome * Open cuts/sores
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Brief Pain Inventory Interference Scale (BPI) | Between group differences at 3-months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Disability Index (PDI) | Changes from Baseline to 3-month Follow-Up | 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 |
| Hospital Anxiety and Depression Scale (HADS) | Changes from Baseline to 3-month Follow-Up | Measures mood on a 14-item scale ranging from 0 to 42 with higher scores meaning a worse outcome |
| Pain Detect Neuropathic Pain Questionnaire (painDETECT) | Changes from Baseline to 3-month Follow-Up | 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 |
| Symptom Impact Questionnaire (SIQR) | Changes from Baseline to 3-month Follow-Up | 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 |
| Patient's Global Impression of Change (PGIC) | Changes from Baseline to 3-month Follow-Up | 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. |
| Pain Catastrophizing Scale (PCS) | Changes from Baseline to 3-month Follow-Up | 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 |
| Satisfaction and Qualitative Questions | 3-month Follow-up | 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. |
| Quantitative Sensory Testing (QST) | Changes from Baseline to 3-month Follow-Up | 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. |
| The Brief Pain Inventory Pain Intensity Scale (BPI) | Changes from Baseline to 3-month Follow-Up | Average pain on a scale of 0-10 with higher scores meaning a worse outcome |
| MasterMyPain App | Daily ratings over 3-months | 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. |
| Healthcare Utilization | Changes from Baseline to 3-month Follow-Up | Monthly clinic and ED visits |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 58 |
| 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. | 57 |
| Total | 115 |
Baseline characteristics
| Characteristic | High Intensity Stimulation | Low Intensity Stimulation | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 12 Participants | 16 Participants | 28 Participants |
| Age, Categorical Between 18 and 65 years | 46 Participants | 41 Participants | 87 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 4 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 52 Participants | 49 Participants | 101 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 4 Participants | 6 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 7 Participants | 13 Participants |
| Race (NIH/OMB) More than one race | 6 Participants | 2 Participants | 8 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) White | 43 Participants | 44 Participants | 87 Participants |
| Sex/Gender, Customized Female | 52 Participants | 45 Participants | 97 Participants |
| Sex/Gender, Customized Male | 5 Participants | 12 Participants | 17 Participants |
| Sex/Gender, Customized Other | 1 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 58 | 0 / 57 |
| other Total, other adverse events | 19 / 58 | 14 / 57 |
| serious Total, serious adverse events | 0 / 58 | 0 / 57 |
Outcome results
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.
Time frame: Between group differences at 3-months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Intensity Stimulation | The Brief Pain Inventory Interference Scale (BPI) | 5.7 score on a scale | Standard Deviation 1.7 |
| Low Intensity Stimulation | The Brief Pain Inventory Interference Scale (BPI) | 5.7 score on a scale | Standard Deviation 2.2 |
Secondary
Healthcare Utilization
Monthly clinic and ED visits
Time frame: Changes from Baseline to 3-month Follow-Up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High Intensity Stimulation | Healthcare Utilization | Clinic visits | 1.3 Number of visits | Standard Deviation 1.1 |
| High Intensity Stimulation | Healthcare Utilization | Hospital visits | 0.0 Number of visits | Standard Deviation 0.2 |
| Low Intensity Stimulation | Healthcare Utilization | Clinic visits | 1.6 Number of visits | Standard Deviation 1.7 |
| Low Intensity Stimulation | Healthcare Utilization | Hospital visits | 0.1 Number of visits | Standard Deviation 0.2 |
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
Time frame: Changes from Baseline to 3-month Follow-Up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Intensity Stimulation | Hospital Anxiety and Depression Scale (HADS) | 19.1 score on a scale | Standard Deviation 7.7 |
| Low Intensity Stimulation | Hospital Anxiety and Depression Scale (HADS) | 16.9 score on a scale | Standard Deviation 7.8 |
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.
Time frame: Daily ratings over 3-months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Intensity Stimulation | MasterMyPain App | 3.9 score on a scale | Standard Deviation 3.2 |
| Low Intensity Stimulation | MasterMyPain App | 5.1 score on a scale | Standard Deviation 3.3 |
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
Time frame: Changes from Baseline to 3-month Follow-Up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Intensity Stimulation | Pain Catastrophizing Scale (PCS) | 25.0 score on a scale | Standard Deviation 11.6 |
| Low Intensity Stimulation | Pain Catastrophizing Scale (PCS) | 24.8 score on a scale | Standard Deviation 13.3 |
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
Time frame: Changes from Baseline to 3-month Follow-Up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Intensity Stimulation | Pain Detect Neuropathic Pain Questionnaire (painDETECT) | 16.1 score on a scale | Standard Deviation 7.6 |
| Low Intensity Stimulation | Pain Detect Neuropathic Pain Questionnaire (painDETECT) | 16.5 score on a scale | Standard Deviation 7.4 |
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
Time frame: Changes from Baseline to 3-month Follow-Up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Intensity Stimulation | Pain Disability Index (PDI) | 38.3 score on a scale | Standard Deviation 14.6 |
| Low Intensity Stimulation | Pain Disability Index (PDI) | 36.3 score on a scale | Standard Deviation 16.8 |
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.
Time frame: Changes from Baseline to 3-month Follow-Up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Intensity Stimulation | Patient's Global Impression of Change (PGIC) | 4.2 score on a scale | Standard Deviation 1.8 |
| Low Intensity Stimulation | Patient's Global Impression of Change (PGIC) | 4.0 score on a scale | Standard Deviation 2 |
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.
Time frame: Changes from Baseline to 3-month Follow-Up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Intensity Stimulation | Quantitative Sensory Testing (QST) | 0.6 score on a scale | Standard Deviation 2 |
| Low Intensity Stimulation | Quantitative Sensory Testing (QST) | 0.0 score on a scale | Standard Deviation 2 |
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.
Time frame: 3-month Follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Intensity Stimulation | Satisfaction and Qualitative Questions | 7.6 score on a 0-10 scale | Standard Deviation 2.9 |
| Low Intensity Stimulation | Satisfaction and Qualitative Questions | 7.4 score on a 0-10 scale | Standard Deviation 2.7 |
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
Time frame: Changes from Baseline to 3-month Follow-Up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Intensity Stimulation | Symptom Impact Questionnaire (SIQR) | 115.8 score on a scale | Standard Deviation 37.4 |
| Low Intensity Stimulation | Symptom Impact Questionnaire (SIQR) | 106.1 score on a scale | Standard Deviation 38.9 |
Secondary
The Brief Pain Inventory Pain Intensity Scale (BPI)
Average pain on a scale of 0-10 with higher scores meaning a worse outcome
Time frame: Changes from Baseline to 3-month Follow-Up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Intensity Stimulation | The Brief Pain Inventory Pain Intensity Scale (BPI) | -0.5 score on a scale | Standard Deviation 2.5 |
| Low Intensity Stimulation | The Brief Pain Inventory Pain Intensity Scale (BPI) | -1.0 score on a scale | Standard Deviation 2.3 |