Microcurrent for Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04949100
• Other study ID #: FWH20210098H
• Status: Recruiting
• Phase: N/A
• Start date: October 25, 2021
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: Mike O'Callaghan Military Hospital
• Contact: Jill M Clark, MBA
• Phone: 7026533298
• Email: jill.m.clark15.civ[@]mail.mil
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 74 Years

Eligibility

**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.

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

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 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.

Locations

Country	Name	City	State
United States	Mike O'Callaghan Military Medical Center	Nellis Air Force Base	Nevada

Sponsors (1)

Lead Sponsor	Collaborator
Paul Crawford

Country where clinical trial is conducted

United States, 

References & Publications (22)

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. Erratum In: Arthritis Res Ther. 2009;11(5):415. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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

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. — View Citation

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

Holm, S. 1979. A simple sequential rejective multiple test procedure. Scand. J. Statistics, 6: 65-70

Lehman, Eric L. (2006). Nonparametrics: Statistical Methods Based on Ranks, Revised, pages 76-81.

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. — View Citation

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. — View Citation

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

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

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. — View Citation

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/.

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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