Clinical Trial of Pulsed Electromagnetic Field (PEMF) Therapy to Treat Symptoms of Lyme Disease Still Present After Treatment with Antibiotics

This page will be updated regularly until results are published. Last update: 17 February 2021.

We firmly believe in open source knowledge and peer review, therefore each step of this trial will be published in high detail excluding only personal data protected under GDPR and our Data Privacy Policy.

This clinical trial has been published on 6 October 2020 on ClinicalTrials.gov with identifier NCT04577053. The first treatment of the trial took place on 7 October 2020.

Applications for Participation Closed

We are no longer accepting participants for this clincial trial. Click here to apply to be a participant in a future trial related to Lyme Disease. (Link opens in a new tab, and we won’t use your contact details to spam you. Read our Privacy Policy and GDPR Statement here.) Yes, we also accept applicants from outside the UK, however, we do not reimburse for travel and so you will likely opt to be in the control group (not receiving treatment).

Initial Results Are In!

The early results on this clinical trial on chronic Lyme Disease symptoms have been calculated.

If you have questions relating to the clinical trial

We prefer receiving enquiries and questions via email to the organizational lead, Kasey. You can email kasey @ biofeedbackcentrebristol. co. uk (removing the spaces in the email address) or use the contact form below.

Information to note:

  • Our new location in Weston-Super-Mare is fully wheelchair accessible.
  • Our COVID-19 Statement can be found online here: https://biofeedbackcentrebristol.co.uk/covid-19-statement/ – and yes, we kindly ask you to bring a face covering along with you to any in-person meetings or treatments
  • Although still trading as Biofeedback Centre Bristol, our name is pending official change with Companies House to: The National Centre for ElectroMagnetic Therapies CIC. This reflects our expansion and commitment to serving our community.
  • Our policy on protecting children and vulnerable adults during treatment and every aspect of our care and interaction with those vulnerable groups will be published online soon. In brief, our policy includes
    • DBS checks on practitioners
    • no removal of clothing whatsoever at any point to receive treatment
    • mandatory guardian attendance at treatments for children younger than 14 years of age
    • immediate reporting to police and/or safeguarding authorities at the council if we think someone might be in danger

GENERAL ENQURIES

  • 07394 870 156

  • kasey@biofeedbackcentrebristol.co.uk

  • Primary Clinic
    Badger House, Ground Floor
    Oldmixon Crescent
    Weston-Super-Mare
    BS24 9AY

  • Clifton Office
    Located in The Practice Rooms
    14 Saint Paul’s Road
    Clifton, Bristol
    BS8 1LR

  • Cotham Office
    Located in The Practice Rooms
    39 Cotham Hill
    Bristol Cotham
    BS6 6JY

OFFICE HOURS

Mon.-Fri. 9:00 – 17:00
Saturday By Appointment Only
Sunday Closed
DBS checked and passed
IICT professional certifications checked and passed

Clinical Trial of Pulsed Electromagnetic Field (PEMF) Therapy to Treat Lingering Symptoms of Lyme Disease After Treatment with Antibiotics

Performed by:
Kasey Phifer, Practitioner and Organiser (a.k.a. “Sponsor/Investigator”)
kasey@biofeedbackcentrebristol.co.uk
07394 870 156
and
Catherine Murphy MScN, retired Nurse Midwife
Independent Data Analyst[email address and phone number not published online, contact us if you’d like to get in touch with her.]

Funded by:
Kasey Phifer, Managing Director
The National Centre for ElectroMagnetic Therapies CIC
trading as The Bristol Centre for Biofeedback
14 Saint Paul’s Road
Bristol BS8 1LR
https://www.facebook.com/BiofeedbackCentreBristol/

Duration:
October 2020 – March 2022 (18 months)

Overview

PEMF Therapy for relief or reduction of lingering symptoms after antibiotic treatment of Lyme disease of participants in the UK.

Symptoms monitored:

  • Muscle ache, myalgia, muscle pain that is acutely located and/or ‘wandering’ (different location on different days)
  • Aching joints
  • Depression
  • Fatigue, general tiredness, loss of energy, general exhaustion
  • Mild, recurrent fever and/or chills occurring regularly

Measurement: Fever and chills recorded by participant’s own measurement of body temperature, recorded at the time when they feel the fever or chill; Other monitored symptoms will be recorded on a 1 – 10 scale reported by the participant in regular surveys throughout the study and after completion.

Dates of surveys:

Treatment / Test Group:

  1. Before 1st treatment session
  2. After 4th treatment session
  3. After 8th and / or final treatment session
  4. 6 months after begin of study / begin of treatment (March 2021)
  5. 12 months “
  6. 18 months”

A total of 6 surveys will be distributed and collected in a COVID-friendly, electronic way to the test group.

Control Group:

  1. Early October 2020
  2. Early December 2020
  3. 6 months later = March 2021
  4. 12 months later = October 2021
  5. 18 months later = March 2022

There will be a total of 5 surveys given to the control group.

Equipment and Protocol used: SCIO device manufactured by QX World in Hungary emitting pulsed electromagnetic fields in sqaure wave form. Protocol will be detailed separately: focus on detoxification, lymph cleanse, various Lyme strains, ‘co-infections’, heavy metal detox, and suggestions produced by artificial intelligence software. Exact protocol will be published separately.

Extra criteria to observe: Are participants seeking other help for their condition? Are they taking prescription or non-pres. painkillers (NSAIDs)? Are they supplementing with echinacea purpea (to balance immune system) and rhodiola rosea (for nervous system)? How much water are they drinking on average each day? Alcohol? Will they do self lymph drainage massage after treatments to ease the ‘detox’ feeling?

Number of Participants: appx. 20 wanted
Control group: 10 not yet confirmed
Group receiving therapy: 12 persons

Duration and frequency of treatment

45 minutes PEMF therapy (after calibration and test scan, so the session lasts 60 minutes in total)
60 minutes between each participant to clean and ventilate room
Once weekly PEMF therapy treatment
8 weeks (2 months) of PEMF therapy treatments consecutively, with 4 weeks minimum asked for

Start of treatment: Week of Monday, 12 October 2020
Planned end of treatment: Early December 2020
(This clinical trial certainly should not have favourable extraneous factors, considering the shortening of days, change of weather to colder temperatures, and more stress with Christmas coming up.)

Location: Badger House, Oldmixon Crescent, Weston-Super-Mare BS24 9AY

The building and therapy room have performed recent risk assessments for reducing and preventing the spread of COVID-19, and strict hygiene measures are in place along with proper ventilation. To view our statement on the prevention of the spread of COVID-19, please follow this link: https://biofeedbackcentrebristol.co.uk/covid-19-statement/

We asked 15 questions to ascertain the eligibility of applicants for participation in the clinical trial. The questions were gathered through Google Forms without affiliation with, support from, or endorsement by Google Inc.

A printout of the application questionnaire can be viewed in PDF format here. (Link opens in a new window.)

Hypothesis

Period measured: 18 months
(Includes before treatment, 4-8 weeks of treatment and after treatment)

Control Group

Control Group symptoms will remain the same or increase (deteriorate or worsen) by 10-20% over the period observed.

The Control Group is not asked to nor required to abstain from any other forms of treatment during the 10 month observational period; Persons in the Control Group are free to – but not encouraged to – pursue holistic, complementary and mainstream medicine for their symptoms related to contraction of Lyme Disease and any other illness that may arise.

In the event of receiving treatment or taking medicine, this information is to be passed along for data collection in the regular surveys. This will be taken into consideration when evaluating the results of the trial and hypothesis.

Test Group

Test Group symptoms will improve (be reduced or eliminated) by 50-75% over the period observed; In particular, the largest improvement will be achieved during the 8 weeks of treatment. After treatment, there may be a slight improvement of symptoms, however, the improvement achieved during treatment is expected to remain the same over the next 7.5 months following treatment with the exception of re-infection or contraction of a different disease or illness.

The Test Group is not asked to nor required to abstain from any other forms of treatment during the 10 month observational period; Persons in the Control Group are free to – but not encouraged to – pursue holistic, complementary and mainstream medicine for their symptoms related to contraction of Lyme Disease and any other illness that may arise.

In the event of receiving treatment or taking medicine, this information is to be passed along for data collection in the regular surveys. This will be taken into consideration when evaluating the results of the trial and hypothesis.

Measurement: 1 to 100 Scale

Worsening/decline or improvement/reduction of symptoms will be measured by the information collected in the surveys. Answers to questions are given subjectively by the participants themselves on a scale of 1 to 100, with 1 being the worst possible or imaginable and 100 being the best possible or imaginable. For example, the worst imaginable answer of “1” to the question of mobility/movement would be in the event that the participant is in a wheelchair or coma. Being confined to a wheelchair is certainly more mobile than lying in a comatose state, however, the answers to each question are subjective and so the participant might believe that a wheelchair would be the worst measure of mobility for him or her.

Weighting of Answers

To weight the improvement or decline respectively for each participant, the average of the first three and last three surveys will be taken. This is to rule out any possible statistical outliers or anomalies due to the participant possibly having a ‘bad day’ or coincidental other illness such as a head cold.

Example Question:
Rate your overall energy level on a scale of 1 to 100, where 1 is the lowest imaginable and 100 is the best, pre-Lyme Disease level possible.

Example Answers:

Participant A

First survey: 45
Second survey: 40
Third survey: 48
25th survey (third to last): 80
26th survey (second to last): 83
27th survey (last or final): 80
Weighting here would be calculated in the following way:
Starting point or “zero point” is the average of the first three surveys
= ( 45 + 40 + 48 ) / 3 = 44.33
Ending point is the average of the last three surveys
= ( 80 + 83 + 80 ) / 3 = 81

An improvement of 100% for this participant would be from 44.33 at the starting point up to 100 at the ending point, what is to be considered a full recovery or full elimination of symptoms. The breadth of full recovery therefore contains a different amount of scala numbers for each participant, because a full recovery is based individually on each participant. This is to avoid an increase or decrease of more than 100%.

Using this example:

  • No improvement would be from 44.33 to [44-44.49], an increase of approximately 0 = 0%
  • Full recovery would be from 44.33 to 100, an increase of 55.67 = 100%
  • Amount of improvement in the example is from 44.33 to 81, an increase of 36.67; We then calculate 36.67 / 55.67 = 68.9% improvement
Participant B (Example Answers)

First survey: 30
Second survey: 25
Third survey: 25
25th survey (third to last): 80
26th survey (second to last): 83
27th survey (last or final): 80

Weighting here would be calculated in the following way:
Starting point or “zero point” is the average of the first three surveys
= ( 30 + 25 + 25 ) / 3 = 26.67
Ending point is the average of the last three surveys
= ( 80 + 83 + 80 ) / 3 = 81
An improvement of 100% for this participant would be from 26.67 at the starting point up to 100 at the ending point, what is to be considered a full recovery or full elimination of symptoms.

Using this example:

  • No improvement would be from 26.67 to [26.5-27], an increase of approximately 0 = 0%
  • Full recovery would be from 26.67 to 100, an increase of 73.33 = 100%
  • Amount of improvement in the example is from 26.67 to 81, an increase of 54.33; We then calculate 54.33 / 73.33 = 74.1% improvement

The WHO-5 Wellbeing Index

We asked the five questions in the World Health Organisation’s Wellbeing Index at the beginning and at the end of the survey. It was our hypothesis that participants would answer more negatively (i.e. with a lower score of wellbeing) after answering detailed questions about Lyme-related symptoms.

Much to our surprise, we were often proven wrong! After focusing on symptoms, quite a few participants answered more optimistically or positively about their wellbeing.

Weighting the WHO-5

In the raw data sheet you’ll see the six answers given numbers 0 through 5. We’ve aggregated the answers given at the start and end of the survey, which led to many “0.5” fractions being listed.

Survey Questions

In the spirit of transparency and helping other organizations endeavoring to conduct clinical trials, we are also publishing the questions to our surveys that are used to measure symptoms and progression or improvement. These surveys will measure the symptoms of Lyme Disease that linger after treatment with antibiotics, over a period of 10 months.

Surveys will be collected using Google Forms. We are not affiliated with or supported by Google Inc. in any way.

Survey for Control Group

Lyme Disease Clinical Trial: Survey of Symptom Development [Control Group]

Please enter your participant code: _____ [Note: This note will not be included in the real survey. We have opted to use codes based on letters of the Roman alphabet rather than numbers, because the latter may have an effect of ‘priming’ participants to then answer the questions in a certain way.]

We understand that symptoms may fluctuate from day to day. Therefore, please answer the following question by considering how you feel/felt today, yesterday and the day before yesterday. Your answer will be a reflection, or an average, of all three days.

1 is the worst and 100 is the best possible or imaginable. Rate your answers below on a scale from 1 to 100.

  1. Do your muscles (not joints) ache, feel stiff or heavy?
    1 = yes, all the time; 100 = no, not at all.
  2. Do your joints (for example ankles, elbows, shoulders) ache, feel stiff/heavy, or don’t allow you a full range of motion?
    1 = yes, all of them and severely; 100 = no, none of them.
  3. Rate your level of overall energy.
    1 = I can barely get out of bed; 100 = I can go about my daily tasks without feeling tired or fatigued at all.
  4. Rate your level of overall anxiety, tension, nervousness and nerve stress.
    1 = Every day I feel jumpy with heart palpitations and fright; 100 = I can keep calm and have just the usual amount of daily stress.
  5. Rate your ability to breathe fully and completely, so that you feel you’re getting an adequate amount of oxygen in your lungs when you inhale. (If you have asthma or have a chest cold at the moment, please let us know below.)
    1 = I need oxygen support; 100 = I can breathe fully and comfortably
  6. Do you have any new symptoms that have arisen? Do you have any new illnesses or injuries that have come up since completing the most recent survey?
    No / Yes
    If yes, please explain: _____________________

Reminder of common sense: If your symptoms are worsening or if you’ve developed new, possibly unrelated symptoms, please contact your General Practitioner / doctor straight away. Our clinical trial is not a replacement for medical treatment. You are able to receive any kind of treatment you’d like – be it medical, natural or holistic – during the course of this study. If you do, please tell us below.

  1. Have you received any treatments since completing the previous survey? (This can include taking vitamins/supplements, joining a meditation class online, seeing a homeopath, visiting a chiropractor, etc.)
    No / Yes
    If yes, please briefly describe: _____________________

Thank you.

Survey for Participants Receiving Treatment

(A) Weeks before and weeks after receiving treatment – same survey as the control group.

(B) Immediately Before and After treatment:

Please enter your participant code: _____

Please answer the following questions relating to how you feel right now at this moment.

1 is the worst and 100 is the best possible or imaginable. Rate your answers below on a scale from 1 to 100.

  1. Do your muscles (not joints) ache, feel stiff or heavy?
    1 = yes, all the time; 100 = no, not at all.
  1. Do your joints (for example ankles, elbows, shoulders) ache, feel stiff/heavy, or don’t allow you a full range of motion?

1 = yes, all of them and severely; 100 = no, none of them.

  1. Rate your level of overall energy.

1 = I can barely get out of bed; 100 = I can go about my daily tasks without feeling tired or fatigued at all.

  1. Rate your level of overall anxiety, tension, nervousness and nerve stress.

1 = Every day I feel jumpy with heart palpitations and fright; 100 = I can keep calm and have just the usual amount of daily stress.

  1. Rate your ability to breathe fully and completely, so that you feel you’re getting an adequate amount of oxygen in your lungs when you inhale. (If you have asthma or have a chest cold at the moment, please let us know below.)
  1. Do you have any new symptoms that have arisen? Do you have any new illnesses or injuries that have come up since completing the most recent survey?

No / Yes

If yes, please explain: _____________________

Reminder of common sense: If your symptoms are worsening or if you’ve developed new, possibly unrelated symptoms, please contact your General Practitioner / doctor straight away. Our clinical trial is not a replacement for medical treatment. You are able to receive any kind of treatment you’d like – be it medical, natural or holistic – during the course of this study. If you do, please tell us below.

Thank you.

Data collection and analysis is protected under our Data Privacy Policy. Participants understand that their personal data will be protected and will remain private and unpublished

Anonymised data will be published and disseminated on this website, by / on third party websites, and in print form.

Data will be collected using Google Forms. This trial is not in collaboration with, affiliated with, supported by nor endorsed by Google Inc.

Click HERE to view and download the full, unabridged initial survey results comparing before and after treatment, in only the treatment arm.

Results have, of course, been anonymised and lightly edited where necessary to preserve accuracy and anonymity. This trial is complete after 3 more surveys have been completed over a total of 18 months.

2021-02-17T14:44:20+00:00