Clinical trial NCT04949100: Microcurrent for Fibromyalgia
Official title: Microcurrent for Fibromyalgia, a Double-Blinded, Placebo-Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fibromyalgia
Keywords: chronic pain
microcurrent
Lead sponsor: Mike O'Callaghan Military Hospital
Sponsor class: FED
First posted: 2021-07-02
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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)

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 or DoD beneficiary aged 18-74 years old.
* Meets diagnostic criteria of fibromyalgia as defined by the American College of Rheumatology 1990 Criteria 1,18 to be consistent with prior research.
* Symptom duration of at least 3 months
* Tender points: having \>10/18 tender points
* Pain-affected areas includes all quadrants of the body
* Other causes excluded clinically
* History of a neck injury sometime in their life

Exclusion Criteria:

* Peripheral neuropathy
* Pregnancy
* History of:

  * Brain/spine surgery
  * Nerve entrapment surgery
  * Severe bony deformities or contracture
  * Hypersensitive reaction to the surface electrode
  * Severe psychological disorders
  * Current alcohol or drug abuse. (caveat: medical marijuana is permitted)
* Active infections
* Active cancer
* Cardiac arrhythmias (If yes, please list _____________)
* Received an organ transplant
* Pacemakers and electrically implanted electronic devices
* Subjects scheduled for surgery will not be eligible to participate in thisstudy until 6 weeks post-surgery.

Primary outcomes:
measure: Revised Fibromyalgia Impact Questionnaire (FIQR)
timeFrame: Day 1
measure: Revised Fibromyalgia Impact Questionnaire (FIQR)
timeFrame: Day 8
measure: Revised Fibromyalgia Impact Questionnaire (FIQR)
timeFrame: Day 15
measure: Measure Yourself Medical Outcome Profile (MYMOP)
timeFrame: Day 1
measure: Measure Yourself Medical Outcome Profile (MYMOP)
timeFrame: Day 8
measure: Measure Yourself Medical Outcome Profile (MYMOP)
timeFrame: Day 15
measure: active range of motion (AROM)
timeFrame: day 1 immediately pre-treatment
measure: active range of motion (AROM)
timeFrame: day 1 immediately post-treatment
measure: active range of motion (AROM)
timeFrame: day 8
measure: active range of motion (AROM)
timeFrame: day 15
Secondary outcomes:
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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