Frequency Specific Microcurrent

Frequency Specific Microcurrent (FSM) uses microamperage current and the resonance effects of frequencies on tissues and conditions to create beneficial changes to symptoms and health.  The Precision Micro ("THERASTIM") FSM device is manufactured by Precision Electronics Ltd and has a 510K (K914813) certificate from the FDA as a class II device, in the category of Transcutaneous Electrical Nerve Stimulation (TENS) device.  FSM alleviates and reverses a series of symptoms and ailments, especially related to pain, that usually have very poor or no response to conventional and/or pharmaceutical treatments.

In preclinical research, direct electric current stimulation increases adenosine triphosphate (ATP) production, protein synthesis and membrane transport5, and possibly interacts with biochemicals on a thermodynamic level.6 Clinical evidence supporting the use of FSM for pain is limited to case reviews and retrospective studies. A review of patients with resistant, chronic myofascial pain in the head, neck, and face found sustained improvement in 49 of 50 cases.7 A second case review of 22 chronic LBP patients found a 3.8-fold average reduction in pain intensity over an average of 5.6 weeks.6 A retrospective study evaluated the impact of FSM on pain and biological markers for pain and inflammation in 54 fybromyalgia patients. The study found that average pain scores on a 10 point Visual Analog Scale significantly (p < 0.0001) decreased from 7.3 (SD = 1.2) to 1.3 (SD = 1.1)  after the first FSM treatment. In a subset of 6 patients, levels of interleukin (IL)-1, IL-6, tumor necrosis factor (TNF)-alpha pro-inflammatory cytokines, and substance P were significantly reduced while beta-endorphin and cortisol levels significantly.8 Beta endorphins are physiologically linked to ACTH and are thought to be the reason for the cortisol increase. This link is supported by the reduction in neuropeptide Y, which follows the stress response, which was observed in the study. Based on the results of the above studies and the lack of evaluation of FSM for Facet Syndrome pain specifically, a study was undertaken to identify the patient profile of FSM users, prior or concomitant treatments sought, typical duration of FSM use, and the analgesic effects of treatment

As part of the MILCAM program, a retrospective study was conducted to evaluate the clinical outcomes of the FSM treatment for patients presenting at the Integrated Pain Solutions Clinic in Portland, Oregon, for Facet Syndrome (FS) management and relief.  Demographic, diagnostic, treatment, and pain data were extracted from medical records of new patients with FS who received FSM, and rated pain pre and post treatment using a 10 point scale. Analysis included means and standard deviation (SD), frequencies, paired t-test and mixed model repeated measures analysis for change in pain, adjusting for covariates (age, sex, concomitant treatments, treatment frequency and duration). Of 319 patients, 72 met inclusion criteria. Patients were mostly women (70.8%), 46.2 (SD = 13.8) years of age, injured in motor vehicle accidents (45.8%), and users of other therapies (43.1%) prior to FSM. They received 8.54 (SD = 8.19) FSM treatments over 12.5 months (SD = 16.9) while 47.2% used no concomitant therapies and 43.1% used at least: chiropractic (29.2%), myofascial trigger point injections (13.9%), or analgesics (5.6%). Pain scores, independent of covariates, decreased significantly (p < 0.0001) from 5.75 (SD = 2.11) to 4.01 (SD = 2.10) after FSM treatment. Half (48.6%) of patients reported a 2 or more point reduction in pain. This study suggests that FSM may significantly reduce chronic pain from FS and warrants further investigation in a randomized, double-blind, placebo-controlled trial.

Farabloc is a noninvasive drug free alternative approach developed by the Farabloc Development Corporation for individuals with fibromyalgia, delayed-onset muscle soreness, and phantom limb pain.  Farabloc consists of metallic fibers woven into a nylon fabric. These fibers consist of iron (85.3%), nickel (10.0%), chromium (2.2%), and manganese (1.0%). Trace elements (less than 1%) include cobalt, copper, magnesium, molybdenum, vanadium, and zinc. The fabric may be custom made into socks, gloves, jackets, blankets or limb covers. It is physically similar to linen and can be tailored or washed. Various forms or sizes can be applied to painful areas of the body. Early variations of the cloth were originally developed in 1972 and formed the basis for a patent in 1987. Although the exact mechanism of action is unknown, it is theorized that Farabloc shields high frequency electromagnetic fields (EMF) that may cause cellular damage.

Phantom Limb Pain

In a double-blind, randomized, sham controlled crossover study, episodic phantom limb pain was assessed using a visual analogue scale.9 Thirty-four individuals were randomized into the Farabloc-sham (n = 18) or sham-Farabloc (n = 16) groups, and evaluated for pain at baseline, first intervention period, washout period, and crossover intervention period. Compared to the baseline and sham intervention periods, pain scores were significantly lower (p < 0.001) during the Farabloc intervention period for both groups. While 17 patients experienced pain relief with Farabloc, only one patient reported complete or near complete pain relief.

The evidence presented in the above clinical studies demonstrates that Farabloc may reduce symptoms of phantom limb pain, delayed-onset muscle soreness and fibromyalgia. This provides rationale for evaluating Farabloc and chronic pain in larger clinical trials.

Objective: The purpose of this study is to test the effectiveness of Farabloc to reduce phantom limb pain in veteran amputees with secondary outcomes to include quality of life and health care utilization.

Research Design: This is a single-center, double-blind, randomized, sham-controlled prospective study that will evaluate Farabloc or sham fabric for amputees with phantom limb pain.

Methodology: After a consecutive case series pilot (n=5) with a two week treatment and follow-up period, researchers will conduct a two-arm, randomized clinical trial (n=60) comparing standard medical care plus active or sham Farabloc fabric treatment for 3 months. After a consecutive case series pilot (n = 5) with a two week treatment and follow-up period, researchers will conduct a two-arm, randomized clinical trial (n = 60) comparing standard medical care plus active or sham Farabloc fabric treatment for 3 months.  Participants with upper and/or lower amputations, who report having 3 or more phantom limb pain (PLP) episodes during the prior 6 weeks, will be recruited from outpatients at The Veteran’s Affairs Long Beach Healthcare System (VALB) in Long Beach, CA.  Researchers and subjects will be blinded to intervention assignment.  The active or sham fabric will be laminated into the prosthesis and provided as a sock cover to be worn over stump when the prosthesis is not used. For one month prior to receiving active or sham Farabloc, participants will record the number of PLP episodes and rate the pain level of each episode to provide a pretest assessment of pain; the pain assessment will be similarly conducted for a 6 and 12 week follow-up and a 1-month post treatment assessment.  After one month monitoring, participants will be assessed for quality of life at pretest, 6 and 12 week follow-up and a 1-month post treatment assessment.  Health care utilization (e.g., use of pain medications, outpatient visits, emergency room visits, and inpatient hospitalization) will be assessed for the prior 12 weeks and at 12 weeks follow-up.    

Based on 2005 estimates,12 38.6 million people were living with HIV worldwide with 4.1 million new infections and 2.8 million deaths as a result of AIDS. In Sub-Saharan Africa, 24.5 million people were infected with HIV in 2005 accounting for 64% of the world’s HIV population. Nearly 2.7 million were newly infected and 2 million died due to AIDS in this region. In Ghana, an African country with a total population of about 22 million, an estimated 320,000 people were living with HIV with 30,000 deaths every year resulting from AIDS. Moreover, only 38% of women and 44% of men in Ghana aged 15 to 24 correctly identified ways to prevent HIV. In 2006, 8.4 billion U.S. dollars were spent on prevention programs while 3 billion U.S. dollars were directed toward care and treatment globally. In 2007, the costs of prevention, care and treatment programs are estimated to increase to 11.4 billion and 5.3 billion U.S. dollars, respectively. Total AIDS funding in 2006 was 14.9 billion U.S. dollars and projections for 2006-2008 indicate funding will increase to 55.1 billion U.S. dollars. HIV/AIDS not only debilitates the lives of those infected with the virus, but also creates a tremendous financial and emotional burden for their caregivers and drains the resources of local public health systems and global outreach organizations.

Nutritional supplementation may delay the progression of AIDS, decrease early mortality, and increase the quality of life of HIV-positive patients. This treatment can serve as an inexpensive adjunct to individuals who may be taking antiretroviral therapy. To our knowledge, there have been no double-blind, randomized, placebo-controlled trials examining the effects of zinc, vitamins A, C, and E, selenium, tryptophan, niacin, glutamine, and NAC on HIV progression with clinically focused endpoints such as diarrhea, wasting, mortality, and quality of life. Therefore, this novel treatment approach merits research in a double blind, randomized, placebo controlled pilot study, and if successful, could lay the groundwork for a larger clinical trial.

References

1.            Eisenberg, DM, et al. Trends in alternative medicine use in the United States, 1990-1997: results of a follow-up national survey. JAMA, 1998. 280: p. 1569-1575.
2.            McEachrane-Gross, FP, Liebschutz, JM, and Berlowitz, D. Use of selected complementary and alternative medicine (CAM) treatments in veterans with cancer or chronic pain: a cross-sectional survey. BMC Complement Altern Med, 2006. Oct 6(6): p. 7.
3.            Baldwin, CM, et al. A profile of military veterans in the southwestern United States who use complementary and alternative medicine: implications for integrated care. Arch Intern Med, 2002. 162(15): p. 1697-704.
4.         Smith, TC, et al. Complementary and alternative medicine use among US Navy and Marine Corps personnel. BMC Complement Altern Med, 2007. 7(16): p. 9.
5.         Cheng, N, et al. The effects of electric currents on ATP generation, protein synthesis, and membrane transport of rat skin. Clin Orthop Relat Res, 1982 171: p. 264-272.
6.            McMakin, CR. Microcurrent therapy: A novel treatment method for chronic low back myofascial pain. J Bodywork Move Ther, 2004. 8: p. 143-153.
7.            McMakin, C. Microcurrent treatment of myofascial pain in the head, neck and face. Top Clin Chiro, 1998. 5(1): p. 29-35.
8.            McMakin, CR, Gregory, WM, and Phillips, TM. Cytokine changes with microcurrent treatment of fibromyalgia associated with cervical spine trauma. J Bodywork Move Ther, 2005. 9: p. 169-176.
9.            Conine, TA, Hershler, C, Alexander, SA, and Crisp, R. The efficacy of Farabloc in the treatment of phantom limb pain. Canadian Journal of Rehabilitation, 1993. 6(3): p. 155-161.
10.       Zhang, J, Clement, D, and Taunton, J. The efficacy of Farabloc, an electromagnetic shield, in attenuating delayed-onset muscle soreness. Clin J Sport Med, 2000. 10(1): p. 15-21.
11.       Bach, GL and Clement, DB. Efficacy of Farabloc as an analgesic in primary fibromyalgia. Clin Rheumatol, 2007. 26(3): p. 405-410.
12.             UNAIDS, 2006 Report on the Global AIDS Epidemic. 2006: Geneva. p. 1-629.

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