Microcurrent Treatment for Chronic Debilitating Pain

Not Applicable

Completed

• Conditions: Pain; Opioid Use
• Interventions: Procedure: Standard treatment + Microcurrent Therapy; Procedure: Standard treatment + placebo

• Registration Number: NCT04011176
• Lead Sponsor: Paul Crawford

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 Timeline

• Study First Submitted: 2019-07-02
• Study First Submitted QC: 2019-07-03
• Study First Posted: 2019-07-08
• Study Start: 2019-12-09
• Primary Completion: 2022-06-01
• Study Completion: 2022-06-01
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-23
• Last Update Posted: 2022-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard treatment + Microcurrent Therapy	Standard treatment + Microcurrent Therapy	100-300µA microcurrent delivered for 20-300 minutes, once a week for 6 weeks
Standard treatment + placebo	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

Primary Outcome Measures

Name	Time	Method
Measure Yourself Medical Outcome Profile (MYMOP)	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
Patient-Reported Outcomes Information System (PROMIS) -57 Profile standardized T-Scores	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.
Defense and Veterans Pain Rating Scale (DVPRS)	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

Name	Time	Method
Opioids taken	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)

Trial Locations

Locations (1)

Mike O'Callaghan Military Medical Center; 🇺🇸 Nellis Air Force Base, Nevada, United States