NCT04949100

Microcurrent for Fibromyalgia

Microcurrent for Fibromyalgia, a Double-Blinded, Placebo-Controlled Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Paul Crawford · Federal
• Sex: All
• Age: 18 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

Explore the use of microcurrent therapy for fibromyalgia patients and evaluate its effect on generalized pain and quality of life. Determine if microcurrent therapy be effectively self-administered by the patient as an adjunct to medical pain management.

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 double-blind study where subjects will not know if they are receiving microcurrent treatment. Day 0, Screening visit (may occur during the patient's regular health visit): * Obtain and document signed Informed Consent document and HIPAA Authorization. * Review past medical history to verify inclusion/exclusion criteria. * Proper hydration is essential before any microcurrent therapy. Hydration is ensured by the patient drinking at least 8 ounces of water 1 hour before treatment. * Record onset and chronicity of fibromyalgia syndrome * Record any medicines that the subject is taking. * Collect demographic information to include age, weight (pounds), height (inches), race, ethnicity, and sex. * Record any standard treatment subject is receiving. Standard treatment may include, but is not limited to one or more of the following: medications, physical therapy, acupuncture, pain management clinic, dry needling, occupational therapy, osteopathic manipulative treatment, Randomization: Subjects will be randomized using complete block design with repeated measure into one of two research-related treatment groups: Group 1 (microcurrent) and Group 2 (placebo microcurrent) Day 1 (may be same day as screening): * Subjects will complete the following pre-treatment: * Measure Yourself Medical Outcome Profile (MYMOP) * Revised Fibromyalgia Impact Questionnaire (FIQR) * Pre-treatment measurement of active range of motion of both wrists, knees, trunk, neck, and head with the Myovision 3G Wireless System (Myovision, Seattle, WA) ¹ . --\*(Myovision will be performed for some subjects based off the availability of Myvision trained staff) * Proper hydration is essential before any microcurrent therapy. Hydration is ensured by the patient drinking at least 8 ounces of water 1 hour before treatment. * Research participant will receive microcurrent according to their randomization group. * Post-treatment measurement of active range of motion of both wrists, knees, trunk, neck, and head with the Myovision 3G Wireless System (Myovision, Seattle, WA) ¹ . * Research participant will be loaned a microcurrent box to bring home with them for this study. They will be instructed to bring the microcurrent box back. A hand-receipt will be signed by the patient accepting responsibility for device replacement if they fail to return or break it. Day 2-7 (at home microcurrent application): -The research participant will self-administer the microcurrent according to their randomization group daily. Day 8: * Subjects will complete the following pre-treatment: * MYMOP * Revised Fibromyalgia Impact Questionnaire (FIQR) * Pre-treatment measurement of active range of motion of both wrists, knees, trunk, neck, and head with the Myovision 3G Wireless System (Myovision, Seattle, WA) ¹ . --\*(Myovision will be performed for some subjects based off the availability of Myvision trained staff) * Proper hydration is essential before any microcurrent therapy. Hydration is ensured by the patient drinking at least 8 ounces of water 1 hour before treatment. * Research participant will receive microcurrent according to their randomization group. * Post-treatment measurement of active range of motion of both wrists, knees, trunk, neck, and head with the Myovision 3G Wireless System (Myovision, Seattle, WA) ¹ . Day 15 Final Visit: * Subjects will complete the following: * MYMOP * Revised Fibromyalgia Impact Questionnaire (FIQR) * Measurement of active range of motion of both wrists, knees, trunk, neck, and head with the Myovision 3G Wireless System (Myovision, Seattle, WA) ¹ . --\*(Myovision will be performed for some subjects based off the availability of Myvision trained staff)

Conditions

• Fibromyalgia

Interventions

Type	Name	Description
DEVICE	Microcurrent Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief	* Duration: 60 minutes. * Electrode placement: There will be one lead placed on the back of the neck and one placed on lower abdomen. * Frequency: Each lead delivers a dual channel microcurrent of 10 and 40 Hz simultaneously. * Amperage: Adjusted according to BMI: 100 μA for an underweight BMI less 20, 300μA for an overweight BMI greater than 30, and 200μA for normal BMI (20-30). Amperage may be adjusted to 20-300 μA according to comfort. * Positioning: The patient remains seated for the first 10 minutes with the investigator watching for any side effects. The patient may stand, sit, lie supine, et cetera for the remainder of treatment.
DEVICE	PLACEBO Microcurrent Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief	* Duration: 60 minutes. * Frequency: None * Electrode placement: There will be one lead placed on the back of the neck and one placed on lower abdomen. * Amperage: None * Positioning: The patient remains seated for the first 10 minutes, again, with the investigator watching for any side effects. The patient may stand, sit, lie supine, et cetera for the remainder of treatment.

Timeline

• Start date: 2021-10-25
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2021-07-02
• Last updated: 2026-01-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study