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OpenTrials
Completed

NCT Number: NCT04011176

Microcurrent Treatment for Chronic Debilitating Pain

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.

Completed

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Key information

Conditions

Pain Neurologic Manifestations Opioid Use Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mike O'Callaghan Military Medical Center

Nellis Air Force Base, Nevada, 89191, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

**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

Treatment and study plan

Standard treatment + placebo

Procedure

Placebo microcurrent

Standard treatment + Microcurrent Therapy

Procedure

Actual microcurrent

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Paul Crawford

Fed

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jul 8, 2019
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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