NCT04461470

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

August 29, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 12, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 3, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 8, 2020

Completed
4.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 12, 2024

Completed
Last Updated

July 16, 2020

Status Verified

February 1, 2020

Enrollment Period

6 months

First QC Date

July 3, 2020

Last Update Submit

July 15, 2020

Conditions

Outcome Measures

Primary Outcomes (4)

  • Pain alleviation

    McGill Index Score 0 - 5

    Imminence - one day

  • Stress alleviation

    McGill Index Score 0 - 5

    Imminence - one day

  • Anti ageing

    McGill Index Score 0 - 5

    Imminence - one day

  • Inflammation quenching

    McGill Index Score 0 - 5

    Imminence - one day

Study Arms (2)

London

pulsed electro resonance hz 4, hz 3, hz 2, hz 3.5 and residual hz 5

Genetic: epigenetic longitudinal waves

All United Kingdom

pulsed electro resonance hz 4, hz 3, hz 2, hz 3.5 and residual hz 5

Genetic: epigenetic longitudinal waves

Interventions

force - inducing energies using electromagnetic field(s)

Also known as: hz
All United KingdomLondon

Eligibility Criteria

Age16 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Distinct community regions - United Kingdom, London.

You may qualify if:

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

You may not qualify if:

  • History of cardiovascular issue

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

hz Clinic

London, E20 3BS, United Kingdom

RECRUITING

Related Publications (14)

  • Bagnato GL, Miceli G, Marino N, Sciortino D, Bagnato GF. Pulsed electromagnetic fields in knee osteoarthritis: a double blind, placebo-controlled, randomized clinical trial. Rheumatology (Oxford). 2016 Apr;55(4):755-62. doi: 10.1093/rheumatology/kev426. Epub 2015 Dec 24.

    PMID: 26705327BACKGROUND
  • Booth CM, Tannock IF. Randomised controlled trials and population-based observational research: partners in the evolution of medical evidence. Br J Cancer. 2014 Feb 4;110(3):551-5. doi: 10.1038/bjc.2013.725. Epub 2014 Jan 14. No abstract available.

    PMID: 24495873BACKGROUND
  • Ferroni L, Gardin C, Dolkart O, Salai M, Barak S, Piattelli A, Amir-Barak H, Zavan B. Pulsed electromagnetic fields increase osteogenetic commitment of MSCs via the mTOR pathway in TNF-alpha mediated inflammatory conditions: an in-vitro study. Sci Rep. 2018 Mar 23;8(1):5108. doi: 10.1038/s41598-018-23499-9.

    PMID: 29572540BACKGROUND
  • Funk RH. Coupling of pulsed electromagnetic fields (PEMF) therapy to molecular grounds of the cell. Am J Transl Res. 2018 May 15;10(5):1260-1272. eCollection 2018.

    PMID: 29887943BACKGROUND
  • Kolifarhood G, Aghaali M, Mozafar Saadati H, Taherpour N, Rahimi S, Izadi N, Hashemi Nazari SS. Epidemiological and Clinical Aspects of COVID-19; a Narrative Review. Arch Acad Emerg Med. 2020 Apr 1;8(1):e41. eCollection 2020.

    PMID: 32259130BACKGROUND
  • Mitchell CA, Long H, Donaldson M, Francese S, Clench MR. Lipid changes within the epidermis of living skin equivalents observed across a time-course by MALDI-MS imaging and profiling. Lipids Health Dis. 2015 Aug 5;14:84. doi: 10.1186/s12944-015-0089-z.

    PMID: 26243140BACKGROUND
  • Mitchell CA, Donaldson M, Francese S, Clench MR. MALDI MSI analysis of lipid changes in living skin equivalents in response to emollient creams containing palmitoylethanolamide. Methods. 2016 Jul 15;104:93-100. doi: 10.1016/j.ymeth.2016.02.001. Epub 2016 Feb 2.

    PMID: 26845462BACKGROUND
  • Mun EJ, Babiker HM, Weinberg U, Kirson ED, Von Hoff DD. Tumor-Treating Fields: A Fourth Modality in Cancer Treatment. Clin Cancer Res. 2018 Jan 15;24(2):266-275. doi: 10.1158/1078-0432.CCR-17-1117. Epub 2017 Aug 1.

    PMID: 28765323BACKGROUND
  • Osler M, Rozing MP, Christensen GT, Andersen PK, Jorgensen MB. Electroconvulsive therapy and risk of dementia in patients with affective disorders: a cohort study. Lancet Psychiatry. 2018 Apr;5(4):348-356. doi: 10.1016/S2215-0366(18)30056-7. Epub 2018 Mar 6.

    PMID: 29523431BACKGROUND
  • Peterchev AV, Wagner TA, Miranda PC, Nitsche MA, Paulus W, Lisanby SH, Pascual-Leone A, Bikson M. Fundamentals of transcranial electric and magnetic stimulation dose: definition, selection, and reporting practices. Brain Stimul. 2012 Oct;5(4):435-53. doi: 10.1016/j.brs.2011.10.001. Epub 2011 Nov 1.

    PMID: 22305345BACKGROUND
  • Phelps DL, Balog J, Gildea LF, Bodai Z, Savage A, El-Bahrawy MA, Speller AV, Rosini F, Kudo H, McKenzie JS, Brown R, Takats Z, Ghaem-Maghami S. The surgical intelligent knife distinguishes normal, borderline and malignant gynaecological tissues using rapid evaporative ionisation mass spectrometry (REIMS). Br J Cancer. 2018 May;118(10):1349-1358. doi: 10.1038/s41416-018-0048-3. Epub 2018 Apr 19.

    PMID: 29670294BACKGROUND
  • Reid B, Zhao M. The Electrical Response to Injury: Molecular Mechanisms and Wound Healing. Adv Wound Care (New Rochelle). 2014 Feb 1;3(2):184-201. doi: 10.1089/wound.2013.0442.

    PMID: 24761358BACKGROUND
  • Sawhney JP, Kothiwale VA, Bisne V, Durgaprasad R, Jadhav P, Chopda M, Vanajakshamma V, Meena R, Vijayaraghavan G, Chawla K, Allu J, Pieper KS, John Camm A, Kakkar AK; GARFIELD-AF Investigators. Risk profiles and one-year outcomes of patients with newly diagnosed atrial fibrillation in India: Insights from the GARFIELD-AF Registry. Indian Heart J. 2018 Nov-Dec;70(6):828-835. doi: 10.1016/j.ihj.2018.09.001. Epub 2018 Sep 12.

    PMID: 30580852BACKGROUND
  • Strauch B, Herman C, Dabb R, Ignarro LJ, Pilla AA. Evidence-based use of pulsed electromagnetic field therapy in clinical plastic surgery. Aesthet Surg J. 2009 Mar-Apr;29(2):135-43. doi: 10.1016/j.asj.2009.02.001.

    PMID: 19371845BACKGROUND

Related Links

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Christopher L Davies

    East London Electric Company

    STUDY CHAIR

Central Study Contacts

Christopher A Mitchell, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Week
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2020

First Posted

July 8, 2020

Study Start

August 29, 2019

Primary Completion

February 12, 2020

Study Completion

September 12, 2024

Last Updated

July 16, 2020

Record last verified: 2020-02

Locations