NCT04011176

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable pain

Timeline
Completed

Started Dec 2019

Longer than P75 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 2, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 8, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

December 9, 2019

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

2.5 years

First QC Date

July 2, 2019

Last Update Submit

September 3, 2024

Conditions

PainOpioid Use

Outcome Measures

Primary Outcomes (43)

  • 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 Outcomes (1)

  • Opioids taken

    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)

Study Arms (2)

Standard treatment + placebo

PLACEBO COMPARATOR

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

Standard treatment + Microcurrent Therapy

EXPERIMENTAL

100-300µA microcurrent delivered for 20-300 minutes, once a week for 6 weeks

Procedure: Standard treatment + Microcurrent Therapy

Interventions

Standard treatment + placeboPROCEDURE

Placebo microcurrent

Standard treatment + placebo
Standard treatment + Microcurrent TherapyPROCEDURE

Actual microcurrent

Standard treatment + Microcurrent Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mike O'Callaghan Military Medical Center

Nellis Air Force Base, Nevada, 89191, United States

Location

Related Publications (13)

  • 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.

    PMID: 27313804BACKGROUND

  • 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.

    PMID: 23495464BACKGROUND

  • 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.

    PMID: 25269133BACKGROUND

  • 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.

    PMID: 26658497BACKGROUND

  • 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.

    PMID: 25896191BACKGROUND

  • 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.

    PMID: 23446501BACKGROUND

  • 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.

    PMID: 22005645BACKGROUND

  • 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.

    PMID: 20527063BACKGROUND

  • 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.

    PMID: 19371845BACKGROUND

  • 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.

    PMID: 27358158BACKGROUND

  • 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.

    PMID: 24315255BACKGROUND

  • 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.

    PMID: 20427917BACKGROUND

  • 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.

    PMID: 19542797BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 2, 2019

First Posted

July 8, 2019

Study Start

December 9, 2019

Primary Completion

June 1, 2022

Study Completion

June 1, 2022

Last Updated

September 19, 2024

Record last verified: 2024-09

Locations

US(1)