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Microcurrent Treatment for Chronic Debilitating Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04011176
Recruitment Status : Recruiting
First Posted : July 8, 2019
Last Update Posted : May 6, 2020
Sponsor:
Information provided by (Responsible Party):
Paul Crawford, Mike O'Callaghan Military Hospital

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.

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

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




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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04011176


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
Publications:

Layout table for additonal information
Responsible Party: Paul Crawford, Principal Investigator, Mike O'Callaghan Military Hospital
ClinicalTrials.gov Identifier: NCT04011176    
Other Study ID Numbers: FWH20190097h
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: May 6, 2020
Last Verified: May 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No