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出境医 / 临床实验 / Microcurrent Treatment for Chronic Debilitating Pain

Microcurrent Treatment for Chronic Debilitating Pain

Study Description
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.

Condition or disease Intervention/treatment Phase
Pain Opioid Use Procedure: Standard treatment + placebo Procedure: Standard treatment + Microcurrent Therapy Not Applicable

Detailed Description:
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.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Microcurrent Treatment for Chronic Debilitating Pain
Actual Study Start Date : December 9, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021
Arms and Interventions
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
Procedure: Standard treatment + placebo
Placebo microcurrent

Experimental: Standard treatment + Microcurrent Therapy
100-300µA microcurrent delivered for 20-300 minutes, once a week for 6 weeks
Procedure: Standard treatment + Microcurrent Therapy
Actual microcurrent

Outcome Measures
Primary Outcome Measures :
  1. 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.


  2. 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.


  3. 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.


  4. 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.


  5. 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.


  6. 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.


  7. 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.


  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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


  17. 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


  18. 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


  19. 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


  20. 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


  21. 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


  22. 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


  23. 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


  24. 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


  25. 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


  26. 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


  27. 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


  28. 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


  29. 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


  30. 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.

  31. 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.

  32. 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.

  33. 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.

  34. 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.

  35. 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.

  36. 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.

  37. 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.

  38. 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.

  39. 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.

  40. 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.

  41. 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.

  42. 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.

  43. 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.


Secondary Outcome Measures :
  1. 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)


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

**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
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Jill M Clark, MBA 7026533298 jill.m.clark15.ctr@mail.mil

Locations
Layout table for location information
United States, Nevada
Mike O'Callaghan Military Medical Center Recruiting
Nellis Air Force Base, Nevada, United States, 89191
Contact: Amanda J Crawford, BA    702-653-3298    amanda.j.crawford.ctr@mail.mil   
Contact: Jill M Clark, MBA/HCM    702-653-3298    jill.m.clark15.ctr@mail.mil   
Sponsors and Collaborators
Paul Crawford
Tracking Information
First Submitted Date  ICMJE July 2, 2019
First Posted Date  ICMJE July 8, 2019
Last Update Posted Date May 6, 2020
Actual Study Start Date  ICMJE December 9, 2019
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 3, 2019)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 3, 2019)
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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Microcurrent Treatment for Chronic Debilitating Pain
Official Title  ICMJE Microcurrent Treatment for Chronic Debilitating Pain
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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Pain
  • Opioid Use
Intervention  ICMJE
  • Procedure: Standard treatment + placebo
    Placebo microcurrent
  • Procedure: Standard treatment + Microcurrent Therapy
    Actual microcurrent
Study Arms  ICMJE
  • 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
    Intervention: Procedure: Standard treatment + placebo
  • Experimental: Standard treatment + Microcurrent Therapy
    100-300µA microcurrent delivered for 20-300 minutes, once a week for 6 weeks
    Intervention: Procedure: Standard treatment + Microcurrent Therapy
Publications *
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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. Review.
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 3, 2019)
170
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

**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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jill M Clark, MBA 7026533298 jill.m.clark15.ctr@mail.mil
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04011176
Other Study ID Numbers  ICMJE FWH20190097h
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Paul Crawford, Mike O'Callaghan Military Hospital
Study Sponsor  ICMJE Paul Crawford
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Mike O'Callaghan Military Hospital
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP