mango
Senior Member (Voting Rights)
There’s been some discussion in other threads about some very bold claims made by Bo Christer Bertilson and Björn Bragée at Bragée ME-center in Stockholm, Sweden.
For example, in an interview on Swedish TV (Malou efter 10, 13 May 2019), Bertilson claimed that close to 90% of the patients at ME-center have some kind of stricture issues in the spine, in the cervical spine. When asked why, he replied “We can’t say. But many have had some kind of trauma, like fallen down or traffic accident or has been horse back riding,…"
They are planning a research study, or maybe it is already happening. At the time of posting I don’t know if the application for ethical approval has been processed yet.
I haven’t been able to find any public info about this study online yet, but I’ve read the ethical approval application — gotten through a FOI request — and I’ll share some parts of it below (translated with the help of Google Translate, sorry about the low quality). The original document is in Swedish, 65 pages.
Clinical, radiological and immunological findings in ME/CFS, other pain conditions or fatigue
Bo Bertilson and Björn Bragée
Bragee Medect AB / Bragée ME-center Stockholm, Sweden
“3.2 Purpose
The project aims at retrospectively mapping anamnestic, clinical, laboratory and radiological findings to the disease Myalgic Encephalomyelitis/Chronic Fatigue syndrome (ME/CFS) and to compare these findings with findings from patients with the diagnosis of fibromyalgia or burnout in order to increase knowledge of possible underlying disease cause and thereby laying the groundwork for improved care.
The mapping will be done through compilation of findings from surveys, clinical body examinations, laboratory samples and cervical spine and brain MRI of over 200 patients who visited the specialist clinic and were diagnosed with ME/CFS and one, as well as a corresponding number of patients diagnosed with fibromyalgia and burnout respectively, who also visited the specialist clinic.
Radiological findings on magnetic camera (MRI) of the cervical spine and brain will be evaluated in particular. This is because our experience and several published studies have shown that ME/CFS and similar conditions such as fibromyalgia may be connected to restricted space in the central nervous system. Space reduction that can lead to neurological symptoms that are not only common, but part of the diagnostic criteria for the condition."
“3.3 Scientific purpose
The main hypothesis is that ME/CFS in a significant proportion of patients can be explained by post-traumatic or other dysfunction in the craniocervical area, which can lead to disturbed flow of cerebrospinal fluid with concomitant elevation intracranial pressure and immunological response in the central nervous system.
The project aims to retrospectively identify anamnestic, clinical, laboratory and radiological findings in the disease Myalgic Encephalomyelitis/Chronic Fatigue syndrome (ME/CFS) and to compare these findings with findings from patients with the diagnosis of fibromyalgia or burnout, in order to increase knowledge of possible underlying disease cause and thereby laying the groundwork for improved care.
In particular, we want to test the hypothesis that patients with ME/CFS have findings suggesting neuropathic or nociplastic (formerly referred to as sensitized) pain that can be traced back to space restriction in the central nervous system which can cause interference with the cerebrospinal flow. Radiological findings on magnetic camera (MRI) of cervical spine and the brain should therefore be specifically evaluated. If the hypothesis is substantiated by the mapping, the investigation and treatment recommendations need to be revised and supplemented."
“3.4 What are the scientific issues? *
Regarding patients that have been diagnosed with ME/CFS or fibromyalgia or burnout at Bragée clinics.
1. What percentage of cervical spine and/or brain MRI has the following?
1a. Tonsillecti
1b. Presence of narrowing of the cervical spine
1c. Increased intracranial pressure measured by the diameter of the optic nerve
2. Are there differences in the incidence of findings in question 1 between patients with and without H-EDS/EDS respectively?
3. What inter-judgment reliability exists when assessing the existence of findings in question 1.
4. What is the correspondence between the diagnosis of nerve impact on the symptom sketch and during magnetic camera examination of the cervical spine and brain?
5. Are there signs of the influence of the autonomic nervous system on body examination, measurement of sweating, pulse rate, temperature and heart activity at rest, stress and change of position?”
“4. Method
Data that has already been collected is reviewed and evaluated. The material consists of radiological examinations, primarily cervical spine and brain MRI, answers to questionnaires, and exam findings and laboratory results documented in the journal.
As regards the assessment of MRI findings, these are made by three independent assessors, a trained specialist in radiology, an experienced ST doctor and a medical student, following an established protocol where we through MRI measure the diameter of the eyeball, the diameter of the eye nerve, the position of the cerebellum in relation to the so-called McRae line, i.e. at the exit of the spinal cord through the foramen magnum. Cervical spine conditions are categorized according to narrowings and their levels. Presence of cysts, spondylolistes, misshapen discs and osteophytes are reported, as well as medullary impact and space restrictions.
This is a study of findings from clinical exams made for diagnostic purposes, and no exams are added or made especially for research purposes, but is determined from clinical and anamnestic findings during normal business.”
“5.1 Expected start date for the project *
2019-02-15
5.2 Expected end date of the project *
2019-12-31”
“8.1 How is the selection of the subject population done? *
The study includes patients enrolled at Bragée clinics. All patients diagnosed with ME/CFS will be included in the study, providing they have given consent to participate in the study, which takes place before and during new visits to the clinic. To create a representative material, patients are studied in randomized order, but if resources allow, as many as possible of those who visited the clinic or visit it during the course of the study will be included in the material. Regarding patients with fibromyalgia and burnout, a selection of patients who have completed rehabilitation and one-year follow-up, meet the criteria below and have given written consent will be studied.”
“8.2 How many subjects will be included in the research project? *
200-500 patients with ME/CFS and 40 patients with fibromyalgia and burnout, respectively.”
“8.3 Which selection criteria will be used for inclusion? *
Patients with ME/CFS must meet the so-called Canadian criteria and have been assessed and referred by a doctor. The patients will be studied in randomized order, i.e. the whole population gets one particular number that is generated randomly and determine the order in which they will be included in the study. Patients with Fibromyalgia should meet the AC R criteria for the diagnosis but not have PostExertional Malaise, the distinguishing symptom for ME/CFS. Patients with burnout should be exhausted without
pain estimate more than 30 in VAS and have at least 4.47 p at performed Shirom Melamed Burned Out Questionnaire. 40 subjects with fibromyalgia and 40 with burnout can be included, and if the number of patients who meet the inclusion criteria are larger, a sample of the patients of the last two years is randomized.”
“13.3 How and when are the results planned to be published? *
Results will be compiled and submitted to scientific journals in 2019, and at medical congresses in 2019 and 2020. Popular science compilation can take place during the same period.”
“14.1 Report any financial agreements with contributors or other financiers
(name and amount)
The research is funded by the principal investigator, no other contributors have been asked or shown any interest.”
For example, in an interview on Swedish TV (Malou efter 10, 13 May 2019), Bertilson claimed that close to 90% of the patients at ME-center have some kind of stricture issues in the spine, in the cervical spine. When asked why, he replied “We can’t say. But many have had some kind of trauma, like fallen down or traffic accident or has been horse back riding,…"
They are planning a research study, or maybe it is already happening. At the time of posting I don’t know if the application for ethical approval has been processed yet.
I haven’t been able to find any public info about this study online yet, but I’ve read the ethical approval application — gotten through a FOI request — and I’ll share some parts of it below (translated with the help of Google Translate, sorry about the low quality). The original document is in Swedish, 65 pages.
Clinical, radiological and immunological findings in ME/CFS, other pain conditions or fatigue
Bo Bertilson and Björn Bragée
Bragee Medect AB / Bragée ME-center Stockholm, Sweden
“3.2 Purpose
The project aims at retrospectively mapping anamnestic, clinical, laboratory and radiological findings to the disease Myalgic Encephalomyelitis/Chronic Fatigue syndrome (ME/CFS) and to compare these findings with findings from patients with the diagnosis of fibromyalgia or burnout in order to increase knowledge of possible underlying disease cause and thereby laying the groundwork for improved care.
The mapping will be done through compilation of findings from surveys, clinical body examinations, laboratory samples and cervical spine and brain MRI of over 200 patients who visited the specialist clinic and were diagnosed with ME/CFS and one, as well as a corresponding number of patients diagnosed with fibromyalgia and burnout respectively, who also visited the specialist clinic.
Radiological findings on magnetic camera (MRI) of the cervical spine and brain will be evaluated in particular. This is because our experience and several published studies have shown that ME/CFS and similar conditions such as fibromyalgia may be connected to restricted space in the central nervous system. Space reduction that can lead to neurological symptoms that are not only common, but part of the diagnostic criteria for the condition."
“3.3 Scientific purpose
The main hypothesis is that ME/CFS in a significant proportion of patients can be explained by post-traumatic or other dysfunction in the craniocervical area, which can lead to disturbed flow of cerebrospinal fluid with concomitant elevation intracranial pressure and immunological response in the central nervous system.
The project aims to retrospectively identify anamnestic, clinical, laboratory and radiological findings in the disease Myalgic Encephalomyelitis/Chronic Fatigue syndrome (ME/CFS) and to compare these findings with findings from patients with the diagnosis of fibromyalgia or burnout, in order to increase knowledge of possible underlying disease cause and thereby laying the groundwork for improved care.
In particular, we want to test the hypothesis that patients with ME/CFS have findings suggesting neuropathic or nociplastic (formerly referred to as sensitized) pain that can be traced back to space restriction in the central nervous system which can cause interference with the cerebrospinal flow. Radiological findings on magnetic camera (MRI) of cervical spine and the brain should therefore be specifically evaluated. If the hypothesis is substantiated by the mapping, the investigation and treatment recommendations need to be revised and supplemented."
“3.4 What are the scientific issues? *
Regarding patients that have been diagnosed with ME/CFS or fibromyalgia or burnout at Bragée clinics.
1. What percentage of cervical spine and/or brain MRI has the following?
1a. Tonsillecti
1b. Presence of narrowing of the cervical spine
1c. Increased intracranial pressure measured by the diameter of the optic nerve
2. Are there differences in the incidence of findings in question 1 between patients with and without H-EDS/EDS respectively?
3. What inter-judgment reliability exists when assessing the existence of findings in question 1.
4. What is the correspondence between the diagnosis of nerve impact on the symptom sketch and during magnetic camera examination of the cervical spine and brain?
5. Are there signs of the influence of the autonomic nervous system on body examination, measurement of sweating, pulse rate, temperature and heart activity at rest, stress and change of position?”
“4. Method
Data that has already been collected is reviewed and evaluated. The material consists of radiological examinations, primarily cervical spine and brain MRI, answers to questionnaires, and exam findings and laboratory results documented in the journal.
As regards the assessment of MRI findings, these are made by three independent assessors, a trained specialist in radiology, an experienced ST doctor and a medical student, following an established protocol where we through MRI measure the diameter of the eyeball, the diameter of the eye nerve, the position of the cerebellum in relation to the so-called McRae line, i.e. at the exit of the spinal cord through the foramen magnum. Cervical spine conditions are categorized according to narrowings and their levels. Presence of cysts, spondylolistes, misshapen discs and osteophytes are reported, as well as medullary impact and space restrictions.
This is a study of findings from clinical exams made for diagnostic purposes, and no exams are added or made especially for research purposes, but is determined from clinical and anamnestic findings during normal business.”
“5.1 Expected start date for the project *
2019-02-15
5.2 Expected end date of the project *
2019-12-31”
“8.1 How is the selection of the subject population done? *
The study includes patients enrolled at Bragée clinics. All patients diagnosed with ME/CFS will be included in the study, providing they have given consent to participate in the study, which takes place before and during new visits to the clinic. To create a representative material, patients are studied in randomized order, but if resources allow, as many as possible of those who visited the clinic or visit it during the course of the study will be included in the material. Regarding patients with fibromyalgia and burnout, a selection of patients who have completed rehabilitation and one-year follow-up, meet the criteria below and have given written consent will be studied.”
“8.2 How many subjects will be included in the research project? *
200-500 patients with ME/CFS and 40 patients with fibromyalgia and burnout, respectively.”
“8.3 Which selection criteria will be used for inclusion? *
Patients with ME/CFS must meet the so-called Canadian criteria and have been assessed and referred by a doctor. The patients will be studied in randomized order, i.e. the whole population gets one particular number that is generated randomly and determine the order in which they will be included in the study. Patients with Fibromyalgia should meet the AC R criteria for the diagnosis but not have PostExertional Malaise, the distinguishing symptom for ME/CFS. Patients with burnout should be exhausted without
pain estimate more than 30 in VAS and have at least 4.47 p at performed Shirom Melamed Burned Out Questionnaire. 40 subjects with fibromyalgia and 40 with burnout can be included, and if the number of patients who meet the inclusion criteria are larger, a sample of the patients of the last two years is randomized.”
“13.3 How and when are the results planned to be published? *
Results will be compiled and submitted to scientific journals in 2019, and at medical congresses in 2019 and 2020. Popular science compilation can take place during the same period.”
“14.1 Report any financial agreements with contributors or other financiers
(name and amount)
The research is funded by the principal investigator, no other contributors have been asked or shown any interest.”
