6-Month Outcomes of PEMF to Nucleotide Sources Revealing Cell Sensory Experience in Pain Relief, Stress Relief and Anti Ageing Restoration (PEMF)

July 15, 2020 updated by: hz Clinic

6-Month Outcomes of Pulsed Electro Resonance to Nucleotide Sources Revealing Cell Sensory Experience in Pain Relief, Stress Relief and Anti-ageing Homeostatic Restoration

Background:

The hz Clinic registry is a programme made of five scheduled cohorts designed to include participants dealing with Immunity compromise, Pain, Ageing and Stress (general and pandemic anxieties) who are to be followed for 6 month to five years in their structured routine of pulsed electro resonance (PEMF) to determine their clinical outcome in the real world, contributing evidence for benchmarking fellow cohort participant variance.

Here we report baseline characteristics, PEMF transfer events and outcomes in participants in the UK. This study serves as a calibration proforma for downstream real world evidence observations of PEMF in the field.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Introduction:

Electro resonance (PEMF) therapy is relatively new, despite the fact that it is considered a gold standard approach in healthcare application.

The base premise of PEMF is to apply field (inducing force) energies to a host, producing a spectrum of physiological benefits (Bagnato et al., 2015). The advantages of PEMF approaches are the vast modalities available in which an inducing force is applied and is configured (low to high hz intensity, frequency and polarity). The disadvantages are, however, dissonances in paradigm trajectory and PEMF seldom interrogation of the in-situ / in-vivo metrics of change in recipient (Funk et al., 2008; Peterchev et al., 2012).

PEMF data in healthcare enables an exercise of compelled judgement(s) across all critical level (pre-clinical, phase I, phase II, phase III, phase IV) system activity. Today there is an apparent disjoint of insight between systems-derived data (imaging) and treatment applied data (remedial action). Some example settings of this include i) electro resonance / surgery as an evidence based tool in clinical decision making (Phelps et al., 2018 and Strauch et al., 2009); ii) in-vitro electro resonance in skin equivalence model (Mitchell et al., 2015 and Mitchell et al., 2016) and bone stimulus model (Ferroni et al., 2018) modelling in-vivo benefit; iii) phase IV anticoagulation and prothrombin ratio 'observations and stratification' using principle component positions, and observing all contributing variances in play (Sawhney et al., 2018).

The unprecedented contribution of pandemic variance (Huang et al., 2020), is heightening a public awareness of how manifold real world evidence is in resolving the insight disjoints. Biomedical problems occur in forms where remote or aseptic application and self observation is paramount to care; particularly in the cases of infection, healing wounds and hydro-electrolyte restoration(s).

In plentiful coverage, PEMF homeostatic benefits on Immunity compromise, Pain, Stress and Ageing are extensively reviewed with Mun et al., (2018); and although the mechanisms of actions are underpinned; our literature search shows that there are seldom real world initiatives, recording wide-spread physiological improvements that PEMF therapy enacts.

Aim:

Here we describe the calibration proforma of PEMF correspondence scoring in longitudinal, physiological and observational outcomes. This study will serve as method development for downstream real world evidence observations of PEMF in the field.

Method:

Ethics statement

All participants provided written informed consent in the online basket checkout at hzclinic.co.uk opting to be therapy subjects. The registry is being conducted in accordance with local regulatory requirements, and the International Conference on Harmonisation-Good Pharmacoepidemiological and Clinical Practice Guidelines.

Procedures and outcomes measures

Baseline data collected at screening included participant characteristics (like age), type of clinical-problem (Stress, Pain, Immunity compromise), date and method of diagnosis if any formal, symptoms, and PEMF treatment (delocalised resonance over nucleotide source inducing post transcription modification (PTM) to ubiquitous properties (U.P.)) 2 hz PTM; 3 hz PTM; 4 hz PTM; 5 hz PTM [request appendix for additional I.P. support].

Data on all components of (and) the McGill Life (Sensory, Affectory, Evaluative, Miscellaneous) Index Chart (recordings) were collected to assess the sensitivities of Pain, Stress, Ageing and Immunity compromise states retrospectively.

hz data were collected using a proprietary electronic case report form (eCRF) captured by trained personnel. Oversight of the operations and data management are managed by the coordinating centre hz Clinic, with supporting entities PropDesk (London, UK) and East London Electric Company (ELEC) (London, UK); and resourcing centres MedCity in conjunction with UCL Partners, Imperial College Health Partners and the Health Innovation Network.

The hz protocol requires that 20% of all eCRFs are monitored against source documentation, that there is an electronic audit trail for all data modifications, and that critical variables are subjected to additional audit (Cohen et al., 2015).

Statistical analysis

This article describes the baseline characteristics, treatment patterns and 6 month outcomes based on national data and for participants included in the UK; data for these analyses were extracted from the registry database on 12th February 2020. Continuous variables are expressed as mean ± standard deviation (SD) and categorical variables as frequency and percentage. Utility of PEMF at baseline was analysed by McGill Life Chart Index scores, calculated retrospectively from the data collected. Participants with missing values were not removed from the study. National normalised ratio (NNR) readings during the 6 months follow up were included in the analysis. We adapted the international normalised ratio (Bonar and Favaloro., 2016) with the acquisition and processing of urine samples for participant metabolome mass fingerprinting and hydration readings as an index, performed (request appendix for additional NNR guidelines). Implausible NNR value of less than 0.8 or greater than 20 were excluded. The distribution of NNR values are described by counts and percentages below, within, and above the therapeutic range, and by the mean, SD, median, and interquartile range (IQR).

Occurrence of major clinical response (primarily, Pain-relief, Stress-relief, anti-oxidation (/ageing) and quenched inflammation) is described using the number of events, the proportion of participants with the event divided by the population at burden at the beginning of the follow-up-period, person-time event rate (per 100 person-years), and 95% confidence interval (CI). We estimated person-year rates using a Poisson model, with the number of events. Only the first occurrences of each event were taken into account. Data analysis was performed at the PropDesk with MatLab (MathsWorks, Massachusetts, USA).

Study Type

Observational

Enrollment (Anticipated)

5000

Contacts and Locations

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

Study Contact

Study Locations

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

16 years to 70 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Distinct community regions - United Kingdom, London.

Description

Inclusion Criteria:

  • Adept to social media / technology uses and convenience of care / health benchmarking

Exclusion Criteria:

  • History of cardiovascular issue

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
London
pulsed electro resonance hz 4, hz 3, hz 2, hz 3.5 and residual hz 5
Genetic: epigenetic longitudinal waves
force - inducing energies using electromagnetic field(s)
Other Names:
  • hz
All United Kingdom
pulsed electro resonance hz 4, hz 3, hz 2, hz 3.5 and residual hz 5
Genetic: epigenetic longitudinal waves
force - inducing energies using electromagnetic field(s)
Other Names:
  • hz

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain alleviation
Time Frame: Imminence - one day
McGill Index Score 0 - 5
Imminence - one day
Stress alleviation
Time Frame: Imminence - one day
McGill Index Score 0 - 5
Imminence - one day
Anti ageing
Time Frame: Imminence - one day
McGill Index Score 0 - 5
Imminence - one day
Inflammation quenching
Time Frame: Imminence - one day
McGill Index Score 0 - 5
Imminence - one day

Collaborators and Investigators

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

Sponsor

hz Clinic

Collaborators

East London Electric Company
PropDesk
MedCity
UCL Partners
Imperial College London Partners
Health Innovation Network

Investigators

  • Study Chair: Christopher L Davies, East London Electric Company

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)

August 29, 2019

Primary Completion (ACTUAL)

February 12, 2020

Study Completion (ANTICIPATED)

September 12, 2024

Study Registration Dates

First Submitted

July 3, 2020

First Submitted That Met QC Criteria

July 7, 2020

First Posted (ACTUAL)

July 8, 2020

Study Record Updates

Last Update Posted (ACTUAL)

July 16, 2020

Last Update Submitted That Met QC Criteria

July 15, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 7012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

researchers can contribute to the cohort and bridge their access to participant-centred data

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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