Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
50 participants
INTERVENTIONAL
2021-10-25
2026-07-31
Brief Summary
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Determine if microcurrent therapy be effectively self-administered by the patient as an adjunct to medical pain management.
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Detailed Description
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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)
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Microcurrent
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
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.
Interventions
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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 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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
74 Years
ALL
No
Sponsors
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Paul Crawford
FED
Responsible Party
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Paul Crawford
Principal Investigator
Locations
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Mike O'Callaghan Military Medical Center
Nellis Air Force Base, Nevada, United States
Countries
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References
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Day A. The development of the MYMOP pictorial version. Acupunct Med. 2004 Jun;22(2):68-71. doi: 10.1136/aim.22.2.68.
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.
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.
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.
Gerhardt J., Cocchiarella L., Lea R. The practical guide to range of motion assessment. American Medical Association; Chicago: 2001. pp. 25-32.
Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
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/.
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.
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.
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.
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.
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.
McMakin: Frequency Specific Microcurrent in Pain Management, Textbook for practitioners. Edinburgh: Elsevier Science Press, 2010
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.
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.
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.
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.
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
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.
Other Identifiers
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FWH20210098H
Identifier Type: -
Identifier Source: org_study_id
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