Microcurrent for Fibromyalgia

Paul Crawford

Status

Active, not recruiting

Conditions

Fibromyalgia

Treatments

Device: PLACEBO Microcurrent Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief

Device: Microcurrent Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT04949100

FWH20210098H

Details and patient eligibility

About

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.

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 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)

Enrollment

50 patients

Sex

All

Ages

18 to 74 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 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.