Clinical trial NCT04011176: Microcurrent Treatment for Chronic Debilitating Pain
Official title: Microcurrent Treatment for Chronic Debilitating Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Opioid Use
Lead sponsor: Mike O'Callaghan Military Hospital
Sponsor class: FED
First posted: 2019-07-08
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Patient-Reported Outcomes Information System (PROMIS) -57 Profile standardized T-Scores
timeFrame: PRE-TREATMENT: time 0 (week 0)
measure: Patient-Reported Outcomes Information System (PROMIS) -57 Profile standardized T-Scores
timeFrame: PRE-TREATMENT: time 1 (week 1)
measure: Patient-Reported Outcomes Information System (PROMIS) -57 Profile standardized T-Scores
timeFrame: PRE-TREATMENT: time 2 (week 2)
measure: Patient-Reported Outcomes Information System (PROMIS) -57 Profile standardized T-Scores
timeFrame: PRE-TREATMENT: time 3 (week 3)
measure: Patient-Reported Outcomes Information System (PROMIS) -57 Profile standardized T-Scores
timeFrame: PRE-TREATMENT: time 4 (week 4)
measure: Patient-Reported Outcomes Information System (PROMIS) -57 Profile standardized T-Scores
timeFrame: PRE-TREATMENT: time 5 (week 5)
measure: Patient-Reported Outcomes Information System (PROMIS) -57 Profile standardized T-Scores
timeFrame: PRE-TREATMENT: time 6 (week 12)
measure: Patient-Reported Outcomes Information System (PROMIS) -57 Profile standardized T-Scores
timeFrame: POST-TREATMENT: time 0 (week 0)
measure: Patient-Reported Outcomes Information System (PROMIS) -57 Profile standardized T-Scores
timeFrame: POST-TREATMENT: time 1 (week 1)
measure: Patient-Reported Outcomes Information System (PROMIS) -57 Profile standardized T-Scores
timeFrame: POST-TREATMENT: time 2 (week 2)
measure: Patient-Reported Outcomes Information System (PROMIS) -57 Profile standardized T-Scores
timeFrame: POST-TREATMENT: time 3 (week 3)
measure: Patient-Reported Outcomes Information System (PROMIS) -57 Profile standardized T-Scores
timeFrame: POST-TREATMENT: time 4 (week 4)
measure: Patient-Reported Outcomes Information System (PROMIS) -57 Profile standardized T-Scores
timeFrame: POST-TREATMENT: time 5 (week 5)
measure: Patient-Reported Outcomes Information System (PROMIS) -57 Profile standardized T-Scores
timeFrame: POST-TREATMENT: time 6 (week 12)
measure: Patient-Reported Outcomes Information System (PROMIS) -57 Profile standardized T-Scores
timeFrame: SCREENING
measure: Measure Yourself Medical Outcome Profile (MYMOP)
timeFrame: PRE-TREATMENT: time 0 (week 0)
measure: Measure Yourself Medical Outcome Profile (MYMOP)
timeFrame: PRE-TREATMENT: time 1 (week 1)
measure: Measure Yourself Medical Outcome Profile (MYMOP)
timeFrame: PRE-TREATMENT: time 2 (week 2)
measure: Measure Yourself Medical Outcome Profile (MYMOP)
timeFrame: PRE-TREATMENT: time 3 (week 3)
measure: Measure Yourself Medical Outcome Profile (MYMOP)
timeFrame: PRE-TREATMENT: time 4 (week 4)
measure: Measure Yourself Medical Outcome Profile (MYMOP)
timeFrame: PRE-TREATMENT: time 5 (week 5)
measure: Measure Yourself Medical Outcome Profile (MYMOP)
timeFrame: PRE-TREATMENT: time 6 (week 12)
measure: Measure Yourself Medical Outcome Profile (MYMOP)
timeFrame: POST-TREATMENT: time 0 (week 0)
measure: Measure Yourself Medical Outcome Profile (MYMOP)
timeFrame: POST-TREATMENT: time 1 (week 1)
measure: Measure Yourself Medical Outcome Profile (MYMOP)
timeFrame: POST-TREATMENT: time 2 (week 2)
measure: Measure Yourself Medical Outcome Profile (MYMOP)
timeFrame: POST-TREATMENT: time 3 (week 3)
measure: Measure Yourself Medical Outcome Profile (MYMOP)
timeFrame: POST-TREATMENT: time 4 (week 4)
measure: Measure Yourself Medical Outcome Profile (MYMOP)
timeFrame: POST-TREATMENT: time 5 (week 5)
measure: Measure Yourself Medical Outcome Profile (MYMOP)
timeFrame: POST-TREATMENT: time 6 (week 12)
measure: Defense and Veterans Pain Rating Scale (DVPRS)
timeFrame: PRE-TREATMENT: time 0 (week 0)
measure: Defense and Veterans Pain Rating Scale (DVPRS)
timeFrame: PRE-TREATMENT: time 1 (week 1)
measure: Defense and Veterans Pain Rating Scale (DVPRS)
timeFrame: PRE-TREATMENT: time 2 (week 2)
measure: Defense and Veterans Pain Rating Scale (DVPRS)
timeFrame: PRE-TREATMENT: time 3 (week 3)
measure: Defense and Veterans Pain Rating Scale (DVPRS)
timeFrame: PRE-TREATMENT: time 4 (week 4)
measure: Defense and Veterans Pain Rating Scale (DVPRS)
timeFrame: PRE-TREATMENT: time 5 (week 5)
measure: Defense and Veterans Pain Rating Scale (DVPRS)
timeFrame: PRE-TREATMENT: time 6 (week 6)
measure: Defense and Veterans Pain Rating Scale (DVPRS)
timeFrame: POST-TREATMENT: time 0 (week 0)
measure: Defense and Veterans Pain Rating Scale (DVPRS)
timeFrame: POST-TREATMENT: time 1 (week 1)
measure: Defense and Veterans Pain Rating Scale (DVPRS)
timeFrame: POST-TREATMENT: time 2 (week 2)
measure: Defense and Veterans Pain Rating Scale (DVPRS)
timeFrame: POST-TREATMENT: time 3 (week 3)
measure: Defense and Veterans Pain Rating Scale (DVPRS)
timeFrame: POST-TREATMENT: time 4 (week 4)
measure: Defense and Veterans Pain Rating Scale (DVPRS)
timeFrame: POST-TREATMENT: time 5 (week 5)
measure: Defense and Veterans Pain Rating Scale (DVPRS)
timeFrame: POST-TREATMENT: time 6 (week 6)
Secondary outcomes:
measure: Opioids taken
timeFrame: 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)
Other outcomes:
Locations:
city: Nellis Air Force Base
country: United States
facility: Mike O'Callaghan Military Medical Center
state: Nevada
Study officials:
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