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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.
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):
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:
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:
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:
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Microcurrent | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microcurrent Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief | Device |
|
| 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. |
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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:
Exclusion Criteria:
Peripheral neuropathy
Pregnancy
History of:
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mike O'Callaghan Military Medical Center | Nellis Air Force Base | Nevada | 89191 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 2306288 | Background | 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. | |
| 12598803 |
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We do not plan on sharing data
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D004561 | Transcutaneous Electric Nerve Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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|
| PLACEBO Microcurrent Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief | Device |
|
|
| 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 |
| 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. |
| 19811630 | 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. |
| 10499139 | 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. |
| 8697497 | 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. |
| Background | McMakin: Frequency Specific Microcurrent in Pain Management, Textbook for practitioners. Edinburgh: Elsevier Science Press, 2010 |
| 7140077 | 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. |
| 27844124 | 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. |
| 22775307 | 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. |
| 20538225 | 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. |
| 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 |
| 19664287 | 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. |
| 15253581 | 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. |
| 10787584 | 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. |
| 20461783 | 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. |
| 23024964 | 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. |
| Background | Gerhardt J., Cocchiarella L., Lea R. The practical guide to range of motion assessment. American Medical Association; Chicago: 2001. pp. 25-32. |
| 17695343 | Background | 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. |
| Background | Lehman, Eric L. (2006). Nonparametrics: Statistical Methods Based on Ranks, Revised, pages 76-81. |
| Background | Holm, S. 1979. A simple sequential rejective multiple test procedure. Scand. J. Statistics, 6: 65-70 |
| Background | 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/. |
| D009422 |
| Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000698 |
| Analgesia |
| D000760 | Anesthesia and Analgesia |