Microcurrent for Fibromyalgia

Study Overview
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Brief Summary
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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
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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)

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

Conditions
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Fibromyalgia

Intervention / Treatment
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* Device: Microcurrent Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief
* Device: PLACEBO Microcurrent Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief


Participation Criteria
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Eligibility Criteria
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**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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Microcurrent<br> | Device: Microcurrent Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief<br>* 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.<br>|
| Placebo Comparator: Placebo<br> | Device: PLACEBO Microcurrent Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Revised Fibromyalgia Impact Questionnaire (FIQR) | The FIQR assesses three domains (function, overall impact and symptoms) from which a total score of pain impact is derived. FMS patients have a mean (SD) total score of 56.6 (19.9) and healthy patients have a mean (SD) total score of 12.1 (11.6). FMS patients' means for function, overall impact and symptoms domains are 15.6, 11.0, and 30.0 respectively. Higher total scores are indicative of greater dysfunction or symptom severity. While total scores are slightly negatively skewed favoring severe cases, scores can be assessed with parametric methods. | Day 1 | 
| Revised Fibromyalgia Impact Questionnaire (FIQR) | The FIQR assesses three domains (function, overall impact and symptoms) from which a total score of pain impact is derived. FMS patients have a mean (SD) total score of 56.6 (19.9) and healthy patients have a mean (SD) total score of 12.1 (11.6). FMS patients' means for function, overall impact and symptoms domains are 15.6, 11.0, and 30.0 respectively. Higher total scores are indicative of greater dysfunction or symptom severity. While total scores are slightly negatively skewed favoring severe cases, scores can be assessed with parametric methods. | Day 8 | 
| Revised Fibromyalgia Impact Questionnaire (FIQR) | The FIQR assesses three domains (function, overall impact and symptoms) from which a total score of pain impact is derived. FMS patients have a mean (SD) total score of 56.6 (19.9) and healthy patients have a mean (SD) total score of 12.1 (11.6). FMS patients' means for function, overall impact and symptoms domains are 15.6, 11.0, and 30.0 respectively. Higher total scores are indicative of greater dysfunction or symptom severity. While total scores are slightly negatively skewed favoring severe cases, scores can be assessed with parametric methods. | Day 15 | 
| Measure Yourself Medical Outcome Profile (MYMOP) | The MYMOP employs 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. Normative values are neither available nor meaningful for the MYMOP as it is individual to each patient; however, a clinically meaningful change is considered to be a change in the scores of more than 1. The MYMOP scales are ordinal and will be assess with nonparametric methods. | Day 1 | 
| Measure Yourself Medical Outcome Profile (MYMOP) | The MYMOP employs 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. Normative values are neither available nor meaningful for the MYMOP as it is individual to each patient; however, a clinically meaningful change is considered to be a change in the scores of more than 1. The MYMOP scales are ordinal and will be assess with nonparametric methods. | Day 8 | 
| Measure Yourself Medical Outcome Profile (MYMOP) | The MYMOP employs 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. Normative values are neither available nor meaningful for the MYMOP as it is individual to each patient; however, a clinically meaningful change is considered to be a change in the scores of more than 1. The MYMOP scales are ordinal and will be assess with nonparametric methods. | Day 15 | 
| active range of motion (AROM) | AROM (degrees) will be measured for both wrists, knees, trunk, neck, and head using the Myovision 3G Wireless System. The data is interval and will be assessed with parametric methods. MyoVision System: MyoVision DynaROM (Dynamic Range Of Motion) is a functional and objective soft tissue injury test that measures muscle guarding and range of motion by assessing both while a patient moves. Data is sent to computer software and graphed for interpretation. DynaROM is FDA cleared, class II diagnostic equipment. *(Myovision will be performed for some subjects based off the availability of Myvision trained staff)* | day 1 immediately pre-treatment | 
| active range of motion (AROM) | AROM (degrees) will be measured for both wrists, knees, trunk, neck, and head using the Myovision 3G Wireless System. The data is interval and will be assessed with parametric methods. MyoVision System: MyoVision DynaROM (Dynamic Range Of Motion) is a functional and objective soft tissue injury test that measures muscle guarding and range of motion by assessing both while a patient moves. Data is sent to computer software and graphed for interpretation. DynaROM is FDA cleared, class II diagnostic equipment. *(Myovision will be performed for some subjects based off the availability of Myvision trained staff)* | day 1 immediately post-treatment | 
| active range of motion (AROM) | AROM (degrees) will be measured for both wrists, knees, trunk, neck, and head using the Myovision 3G Wireless System. The data is interval and will be assessed with parametric methods. MyoVision System: MyoVision DynaROM (Dynamic Range Of Motion) is a functional and objective soft tissue injury test that measures muscle guarding and range of motion by assessing both while a patient moves. Data is sent to computer software and graphed for interpretation. DynaROM is FDA cleared, class II diagnostic equipment. *(Myovision will be performed for some subjects based off the availability of Myvision trained staff)* | day 8 | 
| active range of motion (AROM) | AROM (degrees) will be measured for both wrists, knees, trunk, neck, and head using the Myovision 3G Wireless System. The data is interval and will be assessed with parametric methods. MyoVision System: MyoVision DynaROM (Dynamic Range Of Motion) is a functional and objective soft tissue injury test that measures muscle guarding and range of motion by assessing both while a patient moves. Data is sent to computer software and graphed for interpretation. DynaROM is FDA cleared, class II diagnostic equipment. *(Myovision will be performed for some subjects based off the availability of Myvision trained staff)* | day 15 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic pain, microcurrent