Study Results
Results pending
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Basic Information
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Recruitment Status
COMPLETED
Total Enrollment
50 participants
Study Classification
OBSERVATIONAL
Study Start Date
2021-10-15
Study Completion Date
2022-04-01
Brief Summary
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Professional Applied Kinesiology (PAK) is a system which attempts to evaluate numerous aspects of health (structural, chemical, and mental) by the manual testing of muscles, combined with other standard methods of diagnosis. It leads to a variety of conservative, noninvasive treatments which involves joint manipulations or mobilizations, myofascial therapies, cranial techniques, meridian and acupuncture skills, clinical nutrition and dietary management, counseling skills, evaluating environmental irritants, and various reflex techniques. The expanded validity of the manual muscle test has been extensively described.elsewhere, including by one of the Co-Principal Investigators (Anthony Rosner). Details of Applied Kinesiology and its adjunctive procedures are prescribed by an International College of Applied Kinesiology Board of Examiners, cited for its scholarly and scientific activities.
A convenience sample of 40 patients, ages 18-75, will be administered the magnesium muscle stretch test with blood drawn at the time of the individual's visit. For the muscle test, uniformity of the examiner's force application is to be confirmed with a force transducer, while the clinician's judgment as to whether the muscle test is positive (facilitated) or negative (inhibited) will be confirmed by electrogoniometry, the procedures for both the force transducer and electrogoniometer having been established by one of the Co-PIs (Anthony Rosner) previously. The blood sample is to be submitted to LabCorp for the measurement of red blood cell levels of magnesium. Coded results of the muscle test and magnesium blood levels are to be correlated by an experienced statistician who is blinded to the patient's identity.
A convenience sample of 40 patients, ages 18-75, will be administered the magnesium muscle stretch test with blood drawn at the time of the individual's visit. For the muscle test, uniformity of the examiner's force application is to be confirmed with a force transducer, while the clinician's judgment as to whether the muscle test is positive (facilitated) or negative (inhibited) will be confirmed by electrogoniometry, the procedures for both the force transducer and electrogoniometer having been established by one of the Co-PIs (Anthony Rosner) previously. The blood sample is to be submitted to LabCorp for the measurement of red blood cell levels of magnesium. Coded results of the muscle test and magnesium blood levels are to be correlated by an experienced statistician who is blinded to the patient's identity.
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Detailed Description
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A convenience sample of 40 patients, ages 18-75. is to be selected from those attending the services of Dr. William Maykel at his office in Auburn, Massachusetts. Consenting patients are be given an informed consent form approved by a contract institutional review board (PearlIRB), which they are to sign and return indicating that they fully understand the scope and logistics of the proposed research with the right to withdraw at any time without reprisals. Research subjects will undergo the manual muscle stretch test administered by Dr. William Maykel. Specifically, the stretch test is performed as follows:
1. The patient is seated. The right anterior serratus muscle is tested. The doctor asks the patient to hold the right arm straight out at a 90 degree angle with the thumb pointed toward the ceiling.
2. The muscle test is 5/5.
3. The patient is instructed to raise his or her arm straight up to the ceiling, stretching the anterior serratus muscle. The arm is then brought back to the original test position at a 90 degree angle with the thumb up.
4. The muscle is then retested. If it is now 3/5, this represents a positive magnesium stretch test.
5. The procedure is repeated on one or two other muscles to solidify the diagnostic presence of insufficient magnesium.
Immediately afterward, the patient's blood is drawn by a licensed phlebotomist with samples submitted to LabCorp to determine red blood cell magnesium contents (and other trace metals for future investigations).
Results of the muscle test (inhibited or facilitated) are to be paired with the respective blood magnesium levels and shared with each participant. They will be coded to protect the patient's identity identity and submitted to an experienced statistician for correlation, the results either supporting or refuting the hypothesis which stated that the muscle stretch test is a rapid, inexpensive, and readily available screening test for magnesium deficiency. Correlation will be a binary process, based upon (i) normal or deficient levels of magnesium based upon the muscle testing, and (ii) normal blood cell ranges of magnesium established by the reference laboratory. The identity of patients will be known only to the research staff and kept within a locked file in Dr. Maykel's office for 5 years before being discarded. It will not be shared in any presentations or publications of research results.
1. The patient is seated. The right anterior serratus muscle is tested. The doctor asks the patient to hold the right arm straight out at a 90 degree angle with the thumb pointed toward the ceiling.
2. The muscle test is 5/5.
3. The patient is instructed to raise his or her arm straight up to the ceiling, stretching the anterior serratus muscle. The arm is then brought back to the original test position at a 90 degree angle with the thumb up.
4. The muscle is then retested. If it is now 3/5, this represents a positive magnesium stretch test.
5. The procedure is repeated on one or two other muscles to solidify the diagnostic presence of insufficient magnesium.
Immediately afterward, the patient's blood is drawn by a licensed phlebotomist with samples submitted to LabCorp to determine red blood cell magnesium contents (and other trace metals for future investigations).
Results of the muscle test (inhibited or facilitated) are to be paired with the respective blood magnesium levels and shared with each participant. They will be coded to protect the patient's identity identity and submitted to an experienced statistician for correlation, the results either supporting or refuting the hypothesis which stated that the muscle stretch test is a rapid, inexpensive, and readily available screening test for magnesium deficiency. Correlation will be a binary process, based upon (i) normal or deficient levels of magnesium based upon the muscle testing, and (ii) normal blood cell ranges of magnesium established by the reference laboratory. The identity of patients will be known only to the research staff and kept within a locked file in Dr. Maykel's office for 5 years before being discarded. It will not be shared in any presentations or publications of research results.
Conditions
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Magnesium Deficiency
Study Design
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Observational Model Type
CASE_ONLY
Study Time Perspective
CROSS_SECTIONAL
Interventions
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Applied Kinesiology
An Applied Kinesiology muscle test will be supplemented by a single blood draw for validation.
Intervention Type
DIAGNOSTIC_TEST
Other Intervention Names
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:Blood Draw
Eligibility Criteria
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Inclusion Criteria
* Able to read, speak, and understand English
Exclusion Criteria
* Disability Cognitive impairments History of bleeding disorder Known arterial aneurysm Current pregnancy Involvement in healthcare litigation
Minimum Eligible Age
18 Years
Maximum Eligible Age
75 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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William Maykel, D.C., Wellness Medicine
OTHER
Sponsor Role
collaborator
Anthony Rosner
OTHER
Sponsor Role
lead
Responsible Party
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Anthony Rosner
Co-Principal Investigator-Sponsor
Responsibility Role
SPONSOR_INVESTIGATOR
Principal Investigators
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Anthony L Rosner, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Medical Information Services
Locations
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Malchar Chiropractic Wellness Center
Warwick, Rhode Island, United States
Site Status
Countries
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United States
References
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Rosner AL, Cuthbert SC. Applied kinesiology: distinctions in its definition and interpretation. J Bodyw Mov Ther. 2012 Oct;16(4):464-87. doi: 10.1016/j.jbmt.2012.04.008. Epub 2012 May 11.
Reference Type
RESULT
Volpe SL. Magnesium in disease prevention and overall health. Adv Nutr. 2013 May 1;4(3):378S-83S. doi: 10.3945/an.112.003483.
Reference Type
RESULT
Altura BM, Altura BT. Magnesium and contraction of arterial smooth muscle. Microvasc Res. 1974 Mar;7(2):145-55. doi: 10.1016/0026-2862(74)90001-6. No abstract available.
Reference Type
RESULT
Potter JD, Robertson SP, Johnson JD. Magnesium and the regulation of muscle contraction. Fed Proc. 1981 Oct;40(12):2653-6.
Reference Type
RESULT
Bothe G, Coh A, Auinger A. Efficacy and safety of a natural mineral water rich in magnesium and sulphate for bowel function: a double-blind, randomized, placebo-controlled study. Eur J Nutr. 2017 Mar;56(2):491-499. doi: 10.1007/s00394-015-1094-8. Epub 2015 Nov 18.
Reference Type
RESULT
Mayer ML, Westbrook GL, Guthrie PB. Voltage-dependent block by Mg2+ of NMDA responses in spinal cord neurones. Nature. 1984 May 17-23;309(5965):261-3. doi: 10.1038/309261a0.
Reference Type
RESULT
Nowak L, Bregestovski P, Ascher P, Herbet A, Prochiantz A. Magnesium gates glutamate-activated channels in mouse central neurones. Nature. 1984 Feb 2-8;307(5950):462-5. doi: 10.1038/307462a0.
Reference Type
RESULT
Morris ME. Brain and CSF magnesium concentrations during magnesium deficit in animals and humans: neurological symptoms. Magnes Res. 1992 Dec;5(4):303-13.
Reference Type
RESULT
de Baaij JH, Hoenderop JG, Bindels RJ. Magnesium in man: implications for health and disease. Physiol Rev. 2015 Jan;95(1):1-46. doi: 10.1152/physrev.00012.2014.
Reference Type
RESULT
Yavuz Y, Mollaoglu H, Yurumez Y, Ucok K, Duran L, Tunay K, Akgun L. Therapeutic effect of magnesium sulphate on carbon monoxide toxicity-mediated brain lipid peroxidation. Eur Rev Med Pharmacol Sci. 2013 Feb;17 Suppl 1:28-33.
Reference Type
RESULT
Feldman Z, Gurevitch B, Artru AA, Oppenheim A, Shohami E, Reichenthal E, Shapira Y. Effect of magnesium given 1 hour after head trauma on brain edema and neurological outcome. J Neurosurg. 1996 Jul;85(1):131-7. doi: 10.3171/jns.1996.85.1.0131.
Reference Type
RESULT
Hasturk AE, Harman F, Arca T, Sargon M, Kilinc K, Kaptanoglu E. Neuroprotective effect of magnesium sulfate and dexamethasone on intrauterine ischemia in the fetal rat brain: ultrastructural evaluation. Turk Neurosurg. 2013;23(5):666-71. doi: 10.5137/1019-5149.JTN.8541-13.1.
Reference Type
RESULT
Solomon D, Bunegin L, Albin M. The effect of magnesium sulfate administration on cerebral and cardiac toxicity of bupivacaine in dogs. Anesthesiology. 1990 Feb;72(2):341-6. doi: 10.1097/00000542-199002000-00021.
Reference Type
RESULT
Held K, Antonijevic IA, Kunzel H, Uhr M, Wetter TC, Golly IC, Steiger A, Murck H. Oral Mg(2+) supplementation reverses age-related neuroendocrine and sleep EEG changes in humans. Pharmacopsychiatry. 2002 Jul;35(4):135-43. doi: 10.1055/s-2002-33195.
Reference Type
RESULT
Zieve FJ, Freude KA, Zieve L. Effects of magnesium deficiency on protein and nucleic acid synthesis in vivo. J Nutr. 1977 Dec;107(12):2178-88. doi: 10.1093/jn/107.12.2178.
Reference Type
RESULT
Kenney MA, McCoy H, Williams L. Effects of magnesium deficiency on strength, mass, and composition of rat femur. Calcif Tissue Int. 1994 Jan;54(1):44-9. doi: 10.1007/BF00316289.
Reference Type
RESULT
Bogoroch R, Belanger LF. Skeletal effects of magnesium deficiency in normal, ovariectomized, and estrogen-treated rats. Anat Rec. 1975 Nov;183(3):437-47. doi: 10.1002/ar.1091830308.
Reference Type
RESULT
Rude RK, Singer FR, Gruber HE. Skeletal and hormonal effects of magnesium deficiency. J Am Coll Nutr. 2009 Apr;28(2):131-41. doi: 10.1080/07315724.2009.10719764.
Reference Type
RESULT
Salem M, Kasinski N, Munoz R, Chernow B. Progressive magnesium deficiency increases mortality from endotoxin challenge: protective effects of acute magnesium replacement therapy. Crit Care Med. 1995 Jan;23(1):108-18. doi: 10.1097/00003246-199501000-00019.
Reference Type
RESULT
Andrieux-Domont C, Le van Hung. Effects of magnesium deficiency on reproduction in the white rat. Br J Nutr. 1973 Mar;29(2):203-10. doi: 10.1079/bjn19730095. No abstract available.
Reference Type
RESULT
Stokic E, Romani A, Ilincic B, Kupusinac A, Stosic Z, Isenovic ER. Chronic Latent Magnesium Deficiency in Obesity Decreases Positive Effects of Vitamin D on Cardiometabolic Risk Indicators. Curr Vasc Pharmacol. 2018;16(6):610-617. doi: 10.2174/1570161115666170821154841.
Reference Type
RESULT
Rosanoff A, Weaver CM, Rude RK. Suboptimal magnesium status in the United States: are the health consequences underestimated? Nutr Rev. 2012 Mar;70(3):153-64. doi: 10.1111/j.1753-4887.2011.00465.x. Epub 2012 Feb 15.
Reference Type
RESULT
Whang R. Magnesium deficiency: pathogenesis, prevalence, and clinical implications. Am J Med. 1987 Mar 20;82(3A):24-9. doi: 10.1016/0002-9343(87)90129-x.
Reference Type
RESULT
Schmitt WH Jr, Leisman G. Correlation of applied kinesiology muscle testing findings with serum immunoglobulin levels for food allergies. Int J Neurosci. 1998 Dec;96(3-4):237-44. doi: 10.3109/00207459808986471.
Reference Type
RESULT
Schmitt WH Jr, Yanuck SF. Expanding the neurological examination using functional neurologic assessment: part II neurologic basis of applied kinesiology. Int J Neurosci. 1999 Mar;97(1-2):77-108. doi: 10.3109/00207459908994304.
Reference Type
RESULT
Leisman G, Shambaugh P, Ferentz AH. Somatosensory evoked potential changes during muscle testing. Int J Neurosci. 1989 Mar;45(1-2):143-51. doi: 10.3109/00207458908986227.
Reference Type
RESULT
Lawson A, Calderon L. Interexaminer agreement for applied kinesiology manual muscle testing. Percept Mot Skills. 1997 Apr;84(2):539-46. doi: 10.2466/pms.1997.84.2.539.
Reference Type
RESULT
Cuthbert SC, Goodheart GJ Jr. On the reliability and validity of manual muscle testing: a literature review. Chiropr Osteopat. 2007 Mar 6;15:4. doi: 10.1186/1746-1340-15-4.
Reference Type
RESULT
Related Links
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http://www.icakusa.com
International College of Applied Kinesiology-USA
Other Identifiers
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1004401
Identifier Type: -
Identifier Source: org_study_id
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