Microcurrent Treatment for Chronic Debilitating Pain

Study Overview
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Brief Summary
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To compare the efficacy of standard pain treatment and placebo (a microcurrent faux treatment) as opposed to standard pain treatment and microcurrent therapy in any primary care patients over a three month period.

Detailed Description
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This study is not intended to be definitive and should be considered an exploratory randomized trial to determine conditions for which microcurrent is more effective. Thus, extensive subgroup analyses will be performed so that definitive trials can be developed. This is a single-blind study where subjects will not know if they are receiving microcurrent treatment.

Official Title
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Microcurrent Treatment for Chronic Debilitating Pain

Conditions
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Pain, Opioid Use

Intervention / Treatment
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* Procedure: Standard treatment + placebo
* Procedure: Standard treatment + Microcurrent Therapy


Participation Criteria
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Eligibility Criteria
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**Patients must be able to get care at Nellis Air Force Base (a military installation) in order to participate in this study** Inclusion Criteria: Male and female Active Duty members and DoD beneficiaries Age 18 years or older Chronic debilitating pain PROMIS-57 T score is 60 or above Exclusion Criteria: Pregnant Implanted pacemaker Spinal cord stimulator Illicit drug use including marijuana use Epilepsy or a history of seizures Other implanted device (e.g., insulin pump, opioid pump, or defibrillator) Chronic debilitating pain referred or recruited as measured by PROMIS-57 T score is below 60

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Standard treatment + placebo<br>Placing the microcurrent pads on the patient but not turning on the microcurrent box for 30 minutes once a week for 6 weeks | Procedure: Standard treatment + placebo<br>* Placebo microcurrent<br>|
| Experimental: Standard treatment + Microcurrent Therapy<br>100-300µA microcurrent delivered for 20-300 minutes, once a week for 6 weeks | Procedure: Standard treatment + Microcurrent Therapy<br>* Actual microcurrent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-Reported Outcomes Information System (PROMIS) -57 Profile standardized T-Scores | PROMIS measures provide a common metric: the T-score (mean = 50, standard deviation = 10). In most cases 50 equals the mean in the U.S. general population. PROMIS-57 is a collection of 8-item short forms assessing anxiety, depression, fatigue, pain interference, physical function, sleep disturbance, and ability to participate in social roles and activities as well as a single pain intensity item. | PRE-TREATMENT: time 0 (week 0) | 
| Patient-Reported Outcomes Information System (PROMIS) -57 Profile standardized T-Scores | PROMIS measures provide a common metric: the T-score (mean = 50, standard deviation = 10). In most cases 50 equals the mean in the U.S. general population. PROMIS-57 is a collection of 8-item short forms assessing anxiety, depression, fatigue, pain interference, physical function, sleep disturbance, and ability to participate in social roles and activities as well as a single pain intensity item. | PRE-TREATMENT: time 1 (week 1) | 
| Patient-Reported Outcomes Information System (PROMIS) -57 Profile standardized T-Scores | PROMIS measures provide a common metric: the T-score (mean = 50, standard deviation = 10). In most cases 50 equals the mean in the U.S. general population. PROMIS-57 is a collection of 8-item short forms assessing anxiety, depression, fatigue, pain interference, physical function, sleep disturbance, and ability to participate in social roles and activities as well as a single pain intensity item. | PRE-TREATMENT: time 2 (week 2) | 
| Patient-Reported Outcomes Information System (PROMIS) -57 Profile standardized T-Scores | PROMIS measures provide a common metric: the T-score (mean = 50, standard deviation = 10). In most cases 50 equals the mean in the U.S. general population. PROMIS-57 is a collection of 8-item short forms assessing anxiety, depression, fatigue, pain interference, physical function, sleep disturbance, and ability to participate in social roles and activities as well as a single pain intensity item. | PRE-TREATMENT: time 3 (week 3) | 
| Patient-Reported Outcomes Information System (PROMIS) -57 Profile standardized T-Scores | PROMIS measures provide a common metric: the T-score (mean = 50, standard deviation = 10). In most cases 50 equals the mean in the U.S. general population. PROMIS-57 is a collection of 8-item short forms assessing anxiety, depression, fatigue, pain interference, physical function, sleep disturbance, and ability to participate in social roles and activities as well as a single pain intensity item. | PRE-TREATMENT: time 4 (week 4) | 
| Patient-Reported Outcomes Information System (PROMIS) -57 Profile standardized T-Scores | PROMIS measures provide a common metric: the T-score (mean = 50, standard deviation = 10). In most cases 50 equals the mean in the U.S. general population. PROMIS-57 is a collection of 8-item short forms assessing anxiety, depression, fatigue, pain interference, physical function, sleep disturbance, and ability to participate in social roles and activities as well as a single pain intensity item. | PRE-TREATMENT: time 5 (week 5) | 
| Patient-Reported Outcomes Information System (PROMIS) -57 Profile standardized T-Scores | PROMIS measures provide a common metric: the T-score (mean = 50, standard deviation = 10). In most cases 50 equals the mean in the U.S. general population. PROMIS-57 is a collection of 8-item short forms assessing anxiety, depression, fatigue, pain interference, physical function, sleep disturbance, and ability to participate in social roles and activities as well as a single pain intensity item. | PRE-TREATMENT: time 6 (week 12) | 
| Patient-Reported Outcomes Information System (PROMIS) -57 Profile standardized T-Scores | PROMIS-57 is a collection of 8-item short forms assessing anxiety, depression, fatigue, pain interference, physical function, sleep disturbance, and ability to participate in social roles and activities as well as a single pain intensity item. | POST-TREATMENT: time 0 (week 0) | 
| Patient-Reported Outcomes Information System (PROMIS) -57 Profile standardized T-Scores | PROMIS-57 is a collection of 8-item short forms assessing anxiety, depression, fatigue, pain interference, physical function, sleep disturbance, and ability to participate in social roles and activities as well as a single pain intensity item. | POST-TREATMENT: time 1 (week 1) | 
| Patient-Reported Outcomes Information System (PROMIS) -57 Profile standardized T-Scores | PROMIS-57 is a collection of 8-item short forms assessing anxiety, depression, fatigue, pain interference, physical function, sleep disturbance, and ability to participate in social roles and activities as well as a single pain intensity item. | POST-TREATMENT: time 2 (week 2) | 
| Patient-Reported Outcomes Information System (PROMIS) -57 Profile standardized T-Scores | PROMIS-57 is a collection of 8-item short forms assessing anxiety, depression, fatigue, pain interference, physical function, sleep disturbance, and ability to participate in social roles and activities as well as a single pain intensity item. | POST-TREATMENT: time 3 (week 3) | 
| Patient-Reported Outcomes Information System (PROMIS) -57 Profile standardized T-Scores | PROMIS-57 is a collection of 8-item short forms assessing anxiety, depression, fatigue, pain interference, physical function, sleep disturbance, and ability to participate in social roles and activities as well as a single pain intensity item. | POST-TREATMENT: time 4 (week 4) | 
| Patient-Reported Outcomes Information System (PROMIS) -57 Profile standardized T-Scores | PROMIS-57 is a collection of 8-item short forms assessing anxiety, depression, fatigue, pain interference, physical function, sleep disturbance, and ability to participate in social roles and activities as well as a single pain intensity item. | POST-TREATMENT: time 5 (week 5) | 
| Patient-Reported Outcomes Information System (PROMIS) -57 Profile standardized T-Scores | PROMIS-57 is a collection of 8-item short forms assessing anxiety, depression, fatigue, pain interference, physical function, sleep disturbance, and ability to participate in social roles and activities as well as a single pain intensity item. | POST-TREATMENT: time 6 (week 12) | 
| Patient-Reported Outcomes Information System (PROMIS) -57 Profile standardized T-Scores | PROMIS-57 is a collection of 8-item short forms assessing anxiety, depression, fatigue, pain interference, physical function, sleep disturbance, and ability to participate in social roles and activities as well as a single pain intensity item. | SCREENING | 
| Measure Yourself Medical Outcome Profile (MYMOP) | MYMOP measures the outcomes that the patient considers the most important.The patient chooses one or two symptoms that they are seeking help with, and that they consider to be the most important. They also choose an activity of daily living that is limited or prevented by this problem. These choices are written down in the patient's own words and the patient scores them for severity over the past week on a seven-point scale. Lastly wellbeing is scored on a similar scale. Produces a 7-point scale (0=as good as it could be, 6=as bad as it could be) for individual items of Symptoms, Activity, and Wellbeing as well as the MYMOP profile score | PRE-TREATMENT: time 0 (week 0) | 
| Measure Yourself Medical Outcome Profile (MYMOP) | MYMOP measures the outcomes that the patient considers the most important.The patient chooses one or two symptoms that they are seeking help with, and that they consider to be the most important. They also choose an activity of daily living that is limited or prevented by this problem. These choices are written down in the patient's own words and the patient scores them for severity over the past week on a seven-point scale. Lastly wellbeing is scored on a similar scale. Produces a 7-point scale (0=as good as it could be, 6=as bad as it could be) for individual items of Symptoms, Activity, and Wellbeing as well as the MYMOP profile score | PRE-TREATMENT: time 1 (week 1) | 
| Measure Yourself Medical Outcome Profile (MYMOP) | MYMOP measures the outcomes that the patient considers the most important.The patient chooses one or two symptoms that they are seeking help with, and that they consider to be the most important. They also choose an activity of daily living that is limited or prevented by this problem. These choices are written down in the patient's own words and the patient scores them for severity over the past week on a seven-point scale. Lastly wellbeing is scored on a similar scale. Produces a 7-point scale (0=as good as it could be, 6=as bad as it could be) for individual items of Symptoms, Activity, and Wellbeing as well as the MYMOP profile score | PRE-TREATMENT: time 2 (week 2) | 
| Measure Yourself Medical Outcome Profile (MYMOP) | MYMOP measures the outcomes that the patient considers the most important.The patient chooses one or two symptoms that they are seeking help with, and that they consider to be the most important. They also choose an activity of daily living that is limited or prevented by this problem. These choices are written down in the patient's own words and the patient scores them for severity over the past week on a seven-point scale. Lastly wellbeing is scored on a similar scale. Produces a 7-point scale (0=as good as it could be, 6=as bad as it could be) for individual items of Symptoms, Activity, and Wellbeing as well as the MYMOP profile score | PRE-TREATMENT: time 3 (week 3) | 
| Measure Yourself Medical Outcome Profile (MYMOP) | MYMOP measures the outcomes that the patient considers the most important.The patient chooses one or two symptoms that they are seeking help with, and that they consider to be the most important. They also choose an activity of daily living that is limited or prevented by this problem. These choices are written down in the patient's own words and the patient scores them for severity over the past week on a seven-point scale. Lastly wellbeing is scored on a similar scale. Produces a 7-point scale (0=as good as it could be, 6=as bad as it could be) for individual items of Symptoms, Activity, and Wellbeing as well as the MYMOP profile score | PRE-TREATMENT: time 4 (week 4) | 
| Measure Yourself Medical Outcome Profile (MYMOP) | MYMOP measures the outcomes that the patient considers the most important.The patient chooses one or two symptoms that they are seeking help with, and that they consider to be the most important. They also choose an activity of daily living that is limited or prevented by this problem. These choices are written down in the patient's own words and the patient scores them for severity over the past week on a seven-point scale. Lastly wellbeing is scored on a similar scale. Produces a 7-point scale (0=as good as it could be, 6=as bad as it could be) for individual items of Symptoms, Activity, and Wellbeing as well as the MYMOP profile score | PRE-TREATMENT: time 5 (week 5) | 
| Measure Yourself Medical Outcome Profile (MYMOP) | MYMOP measures the outcomes that the patient considers the most important.The patient chooses one or two symptoms that they are seeking help with, and that they consider to be the most important. They also choose an activity of daily living that is limited or prevented by this problem. These choices are written down in the patient's own words and the patient scores them for severity over the past week on a seven-point scale. Lastly wellbeing is scored on a similar scale. Produces a 7-point scale (0=as good as it could be, 6=as bad as it could be) for individual items of Symptoms, Activity, and Wellbeing as well as the MYMOP profile score | PRE-TREATMENT: time 6 (week 12) | 
| Measure Yourself Medical Outcome Profile (MYMOP) | MYMOP measures the outcomes that the patient considers the most important.On follow-up questionnaires the wording of the previously chosen items is unchanged. Produces a 7-point scale (0=as good as it could be, 6=as bad as it could be) for individual items of Symptoms, Activity, and Wellbeing as well as the MYMOP profile score | POST-TREATMENT: time 0 (week 0) | 
| Measure Yourself Medical Outcome Profile (MYMOP) | MYMOP measures the outcomes that the patient considers the most important.On follow-up questionnaires the wording of the previously chosen items is unchanged. Produces a 7-point scale (0=as good as it could be, 6=as bad as it could be) for individual items of Symptoms, Activity, and Wellbeing as well as the MYMOP profile score | POST-TREATMENT: time 1 (week 1) | 
| Measure Yourself Medical Outcome Profile (MYMOP) | MYMOP measures the outcomes that the patient considers the most important.On follow-up questionnaires the wording of the previously chosen items is unchanged. Produces a 7-point scale (0=as good as it could be, 6=as bad as it could be) for individual items of Symptoms, Activity, and Wellbeing as well as the MYMOP profile score | POST-TREATMENT: time 2 (week 2) | 
| Measure Yourself Medical Outcome Profile (MYMOP) | MYMOP measures the outcomes that the patient considers the most important.On follow-up questionnaires the wording of the previously chosen items is unchanged. Produces a 7-point scale (0=as good as it could be, 6=as bad as it could be) for individual items of Symptoms, Activity, and Wellbeing as well as the MYMOP profile score | POST-TREATMENT: time 3 (week 3) | 
| Measure Yourself Medical Outcome Profile (MYMOP) | MYMOP measures the outcomes that the patient considers the most important.On follow-up questionnaires the wording of the previously chosen items is unchanged. Produces a 7-point scale (0=as good as it could be, 6=as bad as it could be) for individual items of Symptoms, Activity, and Wellbeing as well as the MYMOP profile score | POST-TREATMENT: time 4 (week 4) | 
| Measure Yourself Medical Outcome Profile (MYMOP) | MYMOP measures the outcomes that the patient considers the most important.On follow-up questionnaires the wording of the previously chosen items is unchanged. Produces a 7-point scale (0=as good as it could be, 6=as bad as it could be) for individual items of Symptoms, Activity, and Wellbeing as well as the MYMOP profile score | POST-TREATMENT: time 5 (week 5) | 
| Measure Yourself Medical Outcome Profile (MYMOP) | MYMOP measures the outcomes that the patient considers the most important.On follow-up questionnaires the wording of the previously chosen items is unchanged. Produces a 7-point scale (0=as good as it could be, 6=as bad as it could be) for individual items of Symptoms, Activity, and Wellbeing as well as the MYMOP profile score | POST-TREATMENT: time 6 (week 12) | 
| Defense and Veterans Pain Rating Scale (DVPRS) | The DVPRS consists of an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. It has been confirmed for reliability and validity in measuring both acute and chronic pain, and is currently the standard for pain measurement throughout DoD and VHA health systems. The DVPRS has demonstrated linear scale qualities allowing parametric methods to be used. | PRE-TREATMENT: time 0 (week 0) | 
| Defense and Veterans Pain Rating Scale (DVPRS) | The DVPRS consists of an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. It has been confirmed for reliability and validity in measuring both acute and chronic pain, and is currently the standard for pain measurement throughout DoD and VHA health systems. The DVPRS has demonstrated linear scale qualities allowing parametric methods to be used. | PRE-TREATMENT: time 1 (week 1) | 
| Defense and Veterans Pain Rating Scale (DVPRS) | The DVPRS consists of an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. It has been confirmed for reliability and validity in measuring both acute and chronic pain, and is currently the standard for pain measurement throughout DoD and VHA health systems. The DVPRS has demonstrated linear scale qualities allowing parametric methods to be used. | PRE-TREATMENT: time 2 (week 2) | 
| Defense and Veterans Pain Rating Scale (DVPRS) | The DVPRS consists of an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. It has been confirmed for reliability and validity in measuring both acute and chronic pain, and is currently the standard for pain measurement throughout DoD and VHA health systems. The DVPRS has demonstrated linear scale qualities allowing parametric methods to be used. | PRE-TREATMENT: time 3 (week 3) | 
| Defense and Veterans Pain Rating Scale (DVPRS) | The DVPRS consists of an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. It has been confirmed for reliability and validity in measuring both acute and chronic pain, and is currently the standard for pain measurement throughout DoD and VHA health systems. The DVPRS has demonstrated linear scale qualities allowing parametric methods to be used. | PRE-TREATMENT: time 4 (week 4) | 
| Defense and Veterans Pain Rating Scale (DVPRS) | The DVPRS consists of an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. It has been confirmed for reliability and validity in measuring both acute and chronic pain, and is currently the standard for pain measurement throughout DoD and VHA health systems. The DVPRS has demonstrated linear scale qualities allowing parametric methods to be used. | PRE-TREATMENT: time 5 (week 5) | 
| Defense and Veterans Pain Rating Scale (DVPRS) | The DVPRS consists of an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. It has been confirmed for reliability and validity in measuring both acute and chronic pain, and is currently the standard for pain measurement throughout DoD and VHA health systems. The DVPRS has demonstrated linear scale qualities allowing parametric methods to be used. | PRE-TREATMENT: time 6 (week 6) | 
| Defense and Veterans Pain Rating Scale (DVPRS) | The DVPRS consists of an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. It has been confirmed for reliability and validity in measuring both acute and chronic pain, and is currently the standard for pain measurement throughout DoD and VHA health systems. The DVPRS has demonstrated linear scale qualities allowing parametric methods to be used. | POST-TREATMENT: time 0 (week 0) | 
| Defense and Veterans Pain Rating Scale (DVPRS) | The DVPRS consists of an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. It has been confirmed for reliability and validity in measuring both acute and chronic pain, and is currently the standard for pain measurement throughout DoD and VHA health systems. The DVPRS has demonstrated linear scale qualities allowing parametric methods to be used. | POST-TREATMENT: time 1 (week 1) | 
| Defense and Veterans Pain Rating Scale (DVPRS) | The DVPRS consists of an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. It has been confirmed for reliability and validity in measuring both acute and chronic pain, and is currently the standard for pain measurement throughout DoD and VHA health systems. The DVPRS has demonstrated linear scale qualities allowing parametric methods to be used. | POST-TREATMENT: time 2 (week 2) | 
| Defense and Veterans Pain Rating Scale (DVPRS) | The DVPRS consists of an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. It has been confirmed for reliability and validity in measuring both acute and chronic pain, and is currently the standard for pain measurement throughout DoD and VHA health systems. The DVPRS has demonstrated linear scale qualities allowing parametric methods to be used. | POST-TREATMENT: time 3 (week 3) | 
| Defense and Veterans Pain Rating Scale (DVPRS) | The DVPRS consists of an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. It has been confirmed for reliability and validity in measuring both acute and chronic pain, and is currently the standard for pain measurement throughout DoD and VHA health systems. The DVPRS has demonstrated linear scale qualities allowing parametric methods to be used. | POST-TREATMENT: time 4 (week 4) | 
| Defense and Veterans Pain Rating Scale (DVPRS) | The DVPRS consists of an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. It has been confirmed for reliability and validity in measuring both acute and chronic pain, and is currently the standard for pain measurement throughout DoD and VHA health systems. The DVPRS has demonstrated linear scale qualities allowing parametric methods to be used. | POST-TREATMENT: time 5 (week 5) | 
| Defense and Veterans Pain Rating Scale (DVPRS) | The DVPRS consists of an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. It has been confirmed for reliability and validity in measuring both acute and chronic pain, and is currently the standard for pain measurement throughout DoD and VHA health systems. The DVPRS has demonstrated linear scale qualities allowing parametric methods to be used. | POST-TREATMENT: time 6 (week 6) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioids taken | Opioids taken measured in morphine equivalent units (MEU; milligrams) | screening, time 0 (week 0), time 1 (week 1), time 2 (week 2), time 3 (week 3), time 4 (week 4), time 5 (week 5), time 6 (week 12) |