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:
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:
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:
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)