Microcurrent Treatment for Chronic Debilitating Pain

Paul Crawford

Status: Completed

Conditions: Opioid Use; Pain

Treatments: Procedure: Standard treatment + placebo; Procedure: Standard treatment + Microcurrent Therapy

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT04011176

FWH20190097h

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups, including a placebo group

Standard treatment + placebo

Placebo Comparator group

Description:

Placing the microcurrent pads on the patient but not turning on the microcurrent box for 30 minutes once a week for 6 weeks

Treatment:

Procedure: Standard treatment + placebo

Standard treatment + Microcurrent Therapy

Experimental group

Description:

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

Treatment:

Procedure: Standard treatment + Microcurrent Therapy