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Microcurrent for Fibromyalgia

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ClinicalTrials.gov Identifier: NCT04949100
Recruitment Status : Recruiting
First Posted : July 2, 2021
Last Update Posted : April 13, 2022
Sponsor:
Information provided by (Responsible Party):
Paul Crawford, Mike O'Callaghan Military Hospital

Study Description
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
Fibromyalgia Device: Microcurrent Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief Device: PLACEBO Microcurrent Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Microcurrent for Fibromyalgia, a Double-Blinded, Placebo-Controlled Study
Actual Study Start Date : October 25, 2021
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arms and Interventions
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Arm Intervention/treatment
Experimental: Microcurrent 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.
Placebo Comparator: Placebo 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.


Outcome Measures
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Primary Outcome Measures :
  1. Revised Fibromyalgia Impact Questionnaire (FIQR) [ Time Frame: Day 1 ]
    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.

  2. Revised Fibromyalgia Impact Questionnaire (FIQR) [ Time Frame: Day 8 ]
    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.

  3. Revised Fibromyalgia Impact Questionnaire (FIQR) [ Time Frame: Day 15 ]
    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.

  4. Measure Yourself Medical Outcome Profile (MYMOP) [ Time Frame: Day 1 ]
    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.

  5. Measure Yourself Medical Outcome Profile (MYMOP) [ Time Frame: Day 8 ]
    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.

  6. Measure Yourself Medical Outcome Profile (MYMOP) [ Time Frame: Day 15 ]
    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.

  7. active range of motion (AROM) [ Time Frame: day 1 immediately pre-treatment ]

    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)*


  8. active range of motion (AROM) [ Time Frame: day 1 immediately post-treatment ]

    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)*


  9. active range of motion (AROM) [ Time Frame: day 8 ]

    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)*


  10. active range of motion (AROM) [ Time Frame: day 15 ]

    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)*



Eligibility Criteria
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Ages Eligible for Study:   18 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04949100


Contacts
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Contact: Jill M Clark, MBA 7026533298 jill.m.clark15.civ@mail.mil
Contact: Amanda J Crawford, MSHS 7026533600 amanda.j.crawford.ctr@mail.mil

Locations
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United States, Nevada
Mike O'Callaghan Military Medical Center Recruiting
Nellis Air Force Base, Nevada, United States, 89191
Contact: Amanda J Crawford, BA    702-653-3298    amanda.j.crawford.ctr@mail.mil   
Contact: Jill M Clark, MBA/HCM    702-653-3298    jill.m.clark15.civ@mail.mil   
Sponsors and Collaborators
Paul Crawford
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:
McMakin: Frequency Specific Microcurrent in Pain Management, Textbook for practitioners. Edinburgh: Elsevier Science Press, 2010
McMakin, C.: Cytokine changes with microcurrent treatment of fibromyalgia. Journal of Bodywork and Movement Therapies, 9: 169, 2005
Hewlett, K.: Microcurrent treatment on pain, edema, and decreased muscle force associated with delayed onset muscle soreness: a double-blind, placebo, study. In: Kinesiology & Leisure Sciences: University of Hawaii at Manoa, 2003
Gerhardt J., Cocchiarella L., Lea R. The practical guide to range of motion assessment. American Medical Association; Chicago: 2001. pp. 25-32.
Lehman, Eric L. (2006). Nonparametrics: Statistical Methods Based on Ranks, Revised, pages 76-81.
Holm, S. 1979. A simple sequential rejective multiple test procedure. Scand. J. Statistics, 6: 65-70
R Core Team (2014). R: A language and environment for statistical computing. R Foundation for Statistical Computing, Vienna, Austria. URL http://www.R-project.org/.

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Responsible Party: Paul Crawford, Principal Investigator, Mike O'Callaghan Military Hospital
ClinicalTrials.gov Identifier: NCT04949100    
Other Study ID Numbers: FWH20210098H
First Posted: July 2, 2021    Key Record Dates
Last Update Posted: April 13, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We do not plan on sharing data

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Paul Crawford, Mike O'Callaghan Military Hospital:
chronic pain
microcurrent
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases