- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04011176
Microcurrent Treatment for Chronic Debilitating Pain
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Nevada
-
Nellis Air Force Base, Nevada, United States, 89191
- Mike O'Callaghan Military Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
**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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Standard treatment + placebo
Placing the microcurrent pads on the patient but not turning on the microcurrent box for 30 minutes once a week for 6 weeks
|
Placebo microcurrent
|
Experimental: Standard treatment + Microcurrent Therapy
100-300µA microcurrent delivered for 20-300 minutes, once a week for 6 weeks
|
Actual microcurrent
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient-Reported Outcomes Information System (PROMIS) -57 Profile standardized T-Scores
Time Frame: PRE-TREATMENT: time 0 (week 0)
|
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
Time Frame: PRE-TREATMENT: time 1 (week 1)
|
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
Time Frame: PRE-TREATMENT: time 2 (week 2)
|
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
Time Frame: PRE-TREATMENT: time 3 (week 3)
|
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
Time Frame: PRE-TREATMENT: time 4 (week 4)
|
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
Time Frame: PRE-TREATMENT: time 5 (week 5)
|
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
Time Frame: PRE-TREATMENT: time 6 (week 12)
|
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
Time Frame: POST-TREATMENT: time 0 (week 0)
|
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
Time Frame: POST-TREATMENT: time 1 (week 1)
|
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
Time Frame: POST-TREATMENT: time 2 (week 2)
|
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
Time Frame: POST-TREATMENT: time 3 (week 3)
|
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
Time Frame: POST-TREATMENT: time 4 (week 4)
|
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
Time Frame: POST-TREATMENT: time 5 (week 5)
|
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
Time Frame: POST-TREATMENT: time 6 (week 12)
|
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
Time Frame: SCREENING
|
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)
Time Frame: PRE-TREATMENT: time 0 (week 0)
|
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)
Time Frame: PRE-TREATMENT: time 1 (week 1)
|
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)
Time Frame: PRE-TREATMENT: time 2 (week 2)
|
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)
Time Frame: PRE-TREATMENT: time 3 (week 3)
|
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)
Time Frame: PRE-TREATMENT: time 4 (week 4)
|
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)
Time Frame: PRE-TREATMENT: time 5 (week 5)
|
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)
Time Frame: PRE-TREATMENT: time 6 (week 12)
|
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)
Time Frame: POST-TREATMENT: time 0 (week 0)
|
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)
Time Frame: POST-TREATMENT: time 1 (week 1)
|
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)
Time Frame: POST-TREATMENT: time 2 (week 2)
|
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)
Time Frame: POST-TREATMENT: time 3 (week 3)
|
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)
Time Frame: POST-TREATMENT: time 4 (week 4)
|
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)
Time Frame: POST-TREATMENT: time 5 (week 5)
|
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)
Time Frame: POST-TREATMENT: time 6 (week 12)
|
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)
Time Frame: PRE-TREATMENT: time 0 (week 0)
|
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)
Time Frame: PRE-TREATMENT: time 1 (week 1)
|
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)
Time Frame: PRE-TREATMENT: time 2 (week 2)
|
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)
Time Frame: PRE-TREATMENT: time 3 (week 3)
|
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)
Time Frame: PRE-TREATMENT: time 4 (week 4)
|
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)
Time Frame: PRE-TREATMENT: time 5 (week 5)
|
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)
Time Frame: PRE-TREATMENT: time 6 (week 6)
|
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)
Time Frame: POST-TREATMENT: time 0 (week 0)
|
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)
Time Frame: POST-TREATMENT: time 1 (week 1)
|
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)
Time Frame: POST-TREATMENT: time 2 (week 2)
|
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)
Time Frame: POST-TREATMENT: time 3 (week 3)
|
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)
Time Frame: POST-TREATMENT: time 4 (week 4)
|
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)
Time Frame: POST-TREATMENT: time 5 (week 5)
|
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)
Time Frame: POST-TREATMENT: time 6 (week 6)
|
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
Time Frame: 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)
|
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)
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Levy B, Paulozzi L, Mack KA, Jones CM. Trends in Opioid Analgesic-Prescribing Rates by Specialty, U.S., 2007-2012. Am J Prev Med. 2015 Sep;49(3):409-13. doi: 10.1016/j.amepre.2015.02.020. Epub 2015 Apr 18.
- Strauch B, Herman C, Dabb R, Ignarro LJ, Pilla AA. Evidence-based use of pulsed electromagnetic field therapy in clinical plastic surgery. Aesthet Surg J. 2009 Mar-Apr;29(2):135-43. doi: 10.1016/j.asj.2009.02.001.
- Rohde C, Chiang A, Adipoju O, Casper D, Pilla AA. Effects of pulsed electromagnetic fields on interleukin-1 beta and postoperative pain: a double-blind, placebo-controlled, pilot study in breast reduction patients. Plast Reconstr Surg. 2010 Jun;125(6):1620-1629. doi: 10.1097/PRS.0b013e3181c9f6d3.
- Varney SM, Bebarta VS, Mannina LM, Ramos RG, Ganem VJ, Carey KR. Emergency medicine providers' opioid prescribing practices stratified by gender, age, and years in practice. World J Emerg Med. 2016;7(2):106-10. doi: 10.5847/wjem.j.1920-8642.2016.02.004.
- Jeffery DD, Babeu LA, Nelson LE, Kloc M, Klette K. Prescription drug misuse among U.S. active duty military personnel: a secondary analysis of the 2008 DoD survey of health related behaviors. Mil Med. 2013 Feb;178(2):180-95. doi: 10.7205/milmed-d-12-00192.
- Jeffery DD, May L, Luckey B, Balison BM, Klette KL. Use and abuse of prescribed opioids, central nervous system depressants, and stimulants among U.S. active duty military personnel in FY 2010. Mil Med. 2014 Oct;179(10):1141-8. doi: 10.7205/MILMED-D-14-00002.
- Chen JH, Humphreys K, Shah NH, Lembke A. Distribution of Opioids by Different Types of Medicare Prescribers. JAMA Intern Med. 2016 Feb;176(2):259-61. doi: 10.1001/jamainternmed.2015.6662. No abstract available.
- Gabriel A, Sobota R, Gialich S, Maxwell GP. The use of Targeted MicroCurrent Therapy in postoperative pain management. Plast Surg Nurs. 2013 Jan-Mar;33(1):6-8; quiz 9-10. doi: 10.1097/PSN.0b013e3182844219.
- Pilla A, Fitzsimmons R, Muehsam D, Wu J, Rohde C, Casper D. Electromagnetic fields as first messenger in biological signaling: Application to calmodulin-dependent signaling in tissue repair. Biochim Biophys Acta. 2011 Dec;1810(12):1236-45. doi: 10.1016/j.bbagen.2011.10.001. Epub 2011 Oct 8.
- Iodice P, Lessiani G, Franzone G, Pezzulo G. Efficacy of pulsed low-intensity electric neuromuscular stimulation in reducing pain and disability in patients with myofascial syndrome. J Biol Regul Homeost Agents. 2016 Apr-Jun;30(2):615-20.
- Taylor AG, Anderson JG, Riedel SL, Lewis JE, Kinser PA, Bourguignon C. Cranial electrical stimulation improves symptoms and functional status in individuals with fibromyalgia. Pain Manag Nurs. 2013 Dec;14(4):327-335. doi: 10.1016/j.pmn.2011.07.002. Epub 2011 Oct 6.
- Rajpurohit B, Khatri SM, Metgud D, Bagewadi A. Effectiveness of transcutaneous electrical nerve stimulation and microcurrent electrical nerve stimulation in bruxism associated with masticatory muscle pain--a comparative study. Indian J Dent Res. 2010 Jan-Mar;21(1):104-6. doi: 10.4103/0970-9290.62816.
- Koopman JS, Vrinten DH, van Wijck AJ. Efficacy of microcurrent therapy in the treatment of chronic nonspecific back pain: a pilot study. Clin J Pain. 2009 Jul-Aug;25(6):495-9. doi: 10.1097/AJP.0b013e31819a6f3e.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- FWH20190097h
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Flowonix MedicalApproved for marketingBack Pain | Leg Pain | Trunk Pain | Intractable Pain | Arm Pain
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University Hospital Schleswig-HolsteinZealand University Hospital; European Regional Development Fund; Design School...CompletedPain, Acute | Pain, Chronic | Pain Measurement | Pain, CancerGermany
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Universitat Jaume ICompletedPain, Acute | Pain, Chronic | OncologySpain
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Dr. Negrin University HospitalCompletedPostoperative Pain, Acute | Postoperative Pain, ChronicSpain
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University of Campinas, BrazilCompletedPREGNANCY | LUMBAR BACK PAIN | PELVIC PAIN
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George Washington UniversityRecruitingCervical Fusion | Pain, Back | Pain, Neck | Myofacial PainUnited States
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Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
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Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | VATSTurkey
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Janssen Research & Development, LLCCompletedPain, Radiating | Pain, Burning | Pain, Crushing | Pain, Migratory | Pain, SplittingUnited States, France, Spain, Poland, Portugal
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susanne beckerSNSFCompletedLow Back Pain | Pain, Acute | Pain, ChronicSwitzerland
Clinical Trials on Standard treatment + placebo
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Peking Union Medical College HospitalThe Second Hospital of Hebei Medical University; China-Japan Friendship Hospital and other collaboratorsUnknownAcute Ischemic StrokeChina
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Hospital Clinic of BarcelonaUnknown
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Hospices Civils de LyonTerminatedAnal IncontinenceFrance
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BaroPace Inc.JSS Medical Research Inc.RecruitingHypertension | Heart Failure With Preserved Ejection Fraction (HFpEF)India
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Yale UniversityNational Institutes of Health (NIH)Completed
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The University of Hong KongNot yet recruitingStroke | Small Vessel Cerebrovascular Disease
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Pharmazz, Inc.CompletedHypovolemic ShockIndia
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IRCCS Azienda Ospedaliero-Universitaria di BolognaRecruitingThoracic Cancer | Palliative Care | RadiotherapyItaly
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IRCCS Azienda Ospedaliero-Universitaria di BolognaRecruitingPelvic Cancer | Palliative Care | RadiotherapyItaly
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IRCCS Azienda Ospedaliero-Universitaria di BolognaRecruitingPalliative Care | Brain Metastases | RadiotherapyItaly