NCT04130620

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 14, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 17, 2019

Completed
2 years until next milestone

Study Start

First participant enrolled

October 15, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

May 2, 2022

Status Verified

April 1, 2022

Enrollment Period

6 months

First QC Date

October 14, 2019

Last Update Submit

April 25, 2022

Conditions

Keywords

Magnesium deficiencyApplied Kinesiology

Outcome Measures

Primary Outcomes (2)

  • Applied Kinesiology muscle test result

    Facilitated (strong) or inhibited (weak)

    Change from baseline muscle position to one after test is concluded (3 seconds)

  • Red blood cell level

    Routine blood draw and red blood cell magnesium measurement in mcg/g

    Baseline

Interventions

Applied KinesiologyDIAGNOSTIC_TEST

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

Also known as: :Blood Draw

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Routinely scheduled patients of William Maykel, D.C., receiving chiropractic adjustments, manual muscle testing, and/or nutritional therapy.

You may qualify if:

  • Able to read, speak, and understand English

You may not qualify if:

  • Disability Cognitive impairments History of bleeding disorder Known arterial aneurysm Current pregnancy Involvement in healthcare litigation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Malchar Chiropractic Wellness Center

Warwick, Rhode Island, 02886, United States

Location

Related Publications (28)

  • 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.

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

  • 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.

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

  • 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.

  • 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.

  • 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.

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

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood

MeSH Terms

Conditions

Magnesium Deficiency

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Deficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Anthony L Rosner, Ph.D.

    Medical Information Services

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Co-Principal Investigator-Sponsor

Study Record Dates

First Submitted

October 14, 2019

First Posted

October 17, 2019

Study Start

October 15, 2021

Primary Completion

April 1, 2022

Study Completion

April 1, 2022

Last Updated

May 2, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will share

All collected IPD with patient's identity masked according to HIPAA regulations will be tabulated and described in publications and presentations at professional society meetings.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
The IPD with patient's identity masked according to HIPAA regulations will be shared, starting March 2020 when it will be submitted in manuscript form for publication. It will continue to be shared with resubmissions/and/or professional society meetings for 5 years following that date.
Access Criteria
IPD sharing will occur with patient's identity masked with a statistician, professional journal reviewers and editors, and individuals in professional healthcare who are colleagues and/or who attend professional society meetings.

Locations