Microcurrent for Fibromyalgia

NCT04949100 | Active Not Recruiting FDA Device

• 1 other identifier: FWH20210098H
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia

Keywords

chronic pain; microcurrent

Outcome Measures

Primary Outcomes (10)

• 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

Study Arms (2)

Microcurrent

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

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

* 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.

Placebo

Microcurrent Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief DEVICE

* 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.

Microcurrent

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Paul Crawford: lead

Study Sites (1)

Mike O'Callaghan Military Medical Center

Nellis Air Force Base, Nevada, 89191, United States

Location

Related Publications (22)

• Wolfe F, Smythe HA, Yunus MB, Bennett RM, Bombardier C, Goldenberg DL, Tugwell P, Campbell SM, Abeles M, Clark P, et al. The American College of Rheumatology 1990 Criteria for the Classification of Fibromyalgia. Report of the Multicenter Criteria Committee. Arthritis Rheum. 1990 Feb;33(2):160-72. doi: 10.1002/art.1780330203.

  PMID: 2306288 BACKGROUND

• Sprott H. What can rehabilitation interventions achieve in patients with primary fibromyalgia? Curr Opin Rheumatol. 2003 Mar;15(2):145-50. doi: 10.1097/00002281-200303000-00011.

  PMID: 12598803 BACKGROUND

• Lempp HK, Hatch SL, Carville SF, Choy EH. Patients' experiences of living with and receiving treatment for fibromyalgia syndrome: a qualitative study. BMC Musculoskelet Disord. 2009 Oct 7;10:124. doi: 10.1186/1471-2474-10-124.

  PMID: 19811630 BACKGROUND

• Rossy LA, Buckelew SP, Dorr N, Hagglund KJ, Thayer JF, McIntosh MJ, Hewett JE, Johnson JC. A meta-analysis of fibromyalgia treatment interventions. Ann Behav Med. 1999 Spring;21(2):180-91. doi: 10.1007/BF02908299.

  PMID: 10499139 BACKGROUND

• Bertolucci LE, Grey T. Clinical comparative study of microcurrent electrical stimulation to mid-laser and placebo treatment in degenerative joint disease of the temporomandibular joint. Cranio. 1995 Apr;13(2):116-20. doi: 10.1080/08869634.1995.11678054.

  PMID: 8697497 BACKGROUND

• McMakin: Frequency Specific Microcurrent in Pain Management, Textbook for practitioners. Edinburgh: Elsevier Science Press, 2010

  BACKGROUND

• Cheng N, Van Hoof H, Bockx E, Hoogmartens MJ, Mulier JC, De Dijcker FJ, Sansen WM, De Loecker W. The effects of electric currents on ATP generation, protein synthesis, and membrane transport of rat skin. Clin Orthop Relat Res. 1982 Nov-Dec;(171):264-72.

  PMID: 7140077 BACKGROUND

• Salvat I, Zaldivar P, Monterde S, Montull S, Miralles I, Castel A. Functional status, physical activity level, and exercise regularity in patients with fibromyalgia after Multidisciplinary treatment: retrospective analysis of a randomized controlled trial. Rheumatol Int. 2017 Mar;37(3):377-387. doi: 10.1007/s00296-016-3597-x. Epub 2016 Nov 14.

  PMID: 27844124 BACKGROUND

• McMakin CR, Oschman JL. Visceral and somatic disorders: tissue softening with frequency-specific microcurrent. J Altern Complement Med. 2013 Feb;19(2):170-7. doi: 10.1089/acm.2012.0384. Epub 2012 Jul 9.

  PMID: 22775307 BACKGROUND

• Curtis D, Fallows S, Morris M, McMakin C. The efficacy of frequency specific microcurrent therapy on delayed onset muscle soreness. J Bodyw Mov Ther. 2010 Jul;14(3):272-9. doi: 10.1016/j.jbmt.2010.01.009. Epub 2010 Feb 19.

  PMID: 20538225 BACKGROUND

• McMakin, C.: Cytokine changes with microcurrent treatment of fibromyalgia. Journal of Bodywork and Movement Therapies, 9: 169, 2005

  BACKGROUND

• 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

  BACKGROUND

• Bennett RM, Friend R, Jones KD, Ward R, Han BK, Ross RL. The Revised Fibromyalgia Impact Questionnaire (FIQR): validation and psychometric properties. Arthritis Res Ther. 2009;11(4):R120. doi: 10.1186/ar2783. Epub 2009 Aug 10.

  PMID: 19664287 BACKGROUND

• Day A. The development of the MYMOP pictorial version. Acupunct Med. 2004 Jun;22(2):68-71. doi: 10.1136/aim.22.2.68.

  PMID: 15253581 BACKGROUND

• Paterson C, Britten N. In pursuit of patient-centred outcomes: a qualitative evaluation of the 'Measure Yourself Medical Outcome Profile'. J Health Serv Res Policy. 2000 Jan;5(1):27-36. doi: 10.1177/135581960000500108.

  PMID: 10787584 BACKGROUND

• Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Katz RS, Mease P, Russell AS, Russell IJ, Winfield JB, Yunus MB. The American College of Rheumatology preliminary diagnostic criteria for fibromyalgia and measurement of symptom severity. Arthritis Care Res (Hoboken). 2010 May;62(5):600-10. doi: 10.1002/acr.20140.

  PMID: 20461783 BACKGROUND

• Hauser W, Wolfe F. Diagnosis and diagnostic tests for fibromyalgia (syndrome). Reumatismo. 2012 Sep 28;64(4):194-205. doi: 10.4081/reumatismo.2012.194.

  PMID: 23024964 BACKGROUND

• Gerhardt J., Cocchiarella L., Lea R. The practical guide to range of motion assessment. American Medical Association; Chicago: 2001. pp. 25-32.

  BACKGROUND

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  BACKGROUND

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  BACKGROUND

MeSH Terms

Conditions

Fibromyalgia; Chronic Pain

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 17, 2021
• First Posted: July 2, 2021
• Study Start: October 25, 2021
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)