Validation of the Magnesium Muscle Stretch Test (PAKMGTEST)

April 25, 2022 updated by: Anthony Rosner

Red Blood Cell Validation of Magnesium Deficiency as Determined by a Muscle Stretch Test

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Rhode Island
      • Warwick, Rhode Island, United States, 02886
        • Malchar Chiropractic Wellness Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anthony Rosner

Collaborators

William Maykel, D.C., Wellness Medicine

Investigators

  • Principal Investigator: Anthony L Rosner, Ph.D., Medical Information Services

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2021

Primary Completion (Actual)

April 1, 2022

Study Completion (Actual)

April 1, 2022

Study Registration Dates

First Submitted

October 14, 2019

First Submitted That Met QC Criteria

October 15, 2019

First Posted (Actual)

October 17, 2019

Study Record Updates

Last Update Posted (Actual)

May 2, 2022

Last Update Submitted That Met QC Criteria

April 25, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1004401

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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