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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04130620
Other study ID # 1004401
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 15, 2021
Est. completion date April 1, 2022

Study information

Verified date April 2022
Source William Maykel, D.C., Wellness Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date April 1, 2022
Est. primary completion date April 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Applied Kinesiology
An Applied Kinesiology muscle test will be supplemented by a single blood draw for validation.

Locations

Country Name City State
United States Malchar Chiropractic Wellness Center Warwick Rhode Island

Sponsors (2)

Lead Sponsor Collaborator
Anthony Rosner William Maykel, D.C., Wellness Medicine

Country where clinical trial is conducted

United States, 

References & Publications (28)

Altura BM, Altura BT. Magnesium and contraction of arterial smooth muscle. Microvasc Res. 1974 Mar;7(2):145-55. — View Citation

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. — View Citation

Bogoroch R, Bélanger LF. Skeletal effects of magnesium deficiency in normal, ovariectomized, and estrogen-treated rats. Anat Rec. 1975 Nov;183(3):437-47. — View Citation

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 201 — View Citation

Cuthbert SC, Goodheart GJ Jr. On the reliability and validity of manual muscle testing: a literature review. Chiropr Osteopat. 2007 Mar 6;15:4. — View Citation

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. Review. — View Citation

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. — View Citation

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 — View Citation

Held K, Antonijevic IA, Künzel 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. — View Citation

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. — View Citation

Lawson A, Calderon L. Interexaminer agreement for applied kinesiology manual muscle testing. Percept Mot Skills. 1997 Apr;84(2):539-46. — View Citation

Leisman G, Shambaugh P, Ferentz AH. Somatosensory evoked potential changes during muscle testing. Int J Neurosci. 1989 Mar;45(1-2):143-51. — View Citation

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. — View Citation

Morris ME. Brain and CSF magnesium concentrations during magnesium deficit in animals and humans: neurological symptoms. Magnes Res. 1992 Dec;5(4):303-13. Review. — View Citation

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. — View Citation

Potter JD, Robertson SP, Johnson JD. Magnesium and the regulation of muscle contraction. Fed Proc. 1981 Oct;40(12):2653-6. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Rude RK, Singer FR, Gruber HE. Skeletal and hormonal effects of magnesium deficiency. J Am Coll Nutr. 2009 Apr;28(2):131-41. Review. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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: 10.2174/15701611156 — View Citation

Volpe SL. Magnesium in disease prevention and overall health. Adv Nutr. 2013 May 1;4(3):378S-83S. doi: 10.3945/an.112.003483. Review. — View Citation

Whang R. Magnesium deficiency: pathogenesis, prevalence, and clinical implications. Am J Med. 1987 Mar 20;82(3A):24-9. — View Citation

Yavuz Y, Mollaoglu H, Yürümez Y, Ucok K, Duran L, Tünay K, Akgün 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. — View Citation

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. — View Citation

* Note: There are 28 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Applied Kinesiology muscle test result Facilitated (strong) or inhibited (weak) Change from baseline muscle position to one after test is concluded (3 seconds)
Primary Red blood cell level Routine blood draw and red blood cell magnesium measurement in mcg/g Baseline
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