The MED Study, Bo Christer Bertilson (Sweden)

mango

mango

Senior Member (Voting Rights)
"Myalgic Encephalomyelitis/Chronic Fatigue Syndrome and associated conditions and improved handling, investigation and diagnostics (the MED Study)"

This project is run by Bo Christer Bertilson at Bragée Clinics in collaboration with Karolinska Institutet (Department of Neurobiology, Care Sciences and Society) in Stockholm, Sweden.

The data collection was planned to start in the autumn of 2018 and will last for about three years, until 2021.

The Ethical Review Authority approved the application Dec 12 2018.

How the study is described to participants:
“A project for improved pain analysis, where the use of a complaints sketch and a simple neurological examination is used. The goal is to increase healthcare providers' knowledge about long-term conditions with symptoms with unknown cause such as widespread pain, sleep disorders, fatigue, muscle problems (weakness, fatiguability), and increased susceptibility to infection. Pain analyzes will eventually enable correct treatment as early as possible for people with long-term and difficult-to-treat problems."

How the study is described to the Ethical Review Authority:
"The overall aim of the project is to describe the findings for cervical nerve impact in the disease myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and associated conditions, in order to help determine the cause of the disease and lead to improved care. Other purposes are to investigate the usefulness of a complaints sketch as a diagnostic method for detecting instability/nerve impact and describing which radiological findings can be identified for ME/CFS and associated conditions."

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mango's notes:

Translated with the help of Google, so please be aware that there might be mistakes.

The "complaints sketch" is an outline of a human body drawn on a paper, and the patient is asked to make marks on the paper to indicate where pain and other symptoms are present.

The "associated conditions" mentioned in the title are according to this researcher: fibromyalgia, long-term concitions after neck and head trauma -- whiplash associated disorders (WAD), and post concussion syndrome.

They claim that "a majority of the hundreds of patients referred" to their clinic, Bragée ME Center, "have neurological disorder findings that can be associated with the cervical/craniocervical junction."
 
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Info to participants:

"The study is conducted in conjunction with your regular clinic visits. You will be asked to fill out a "complaint sketch", and a doctor and a physiotherapist will do a simple examination of joint mobility and neurology. The complaints sketch is a method in which the patient makes marks on a drawing of a human figure to indicate where the symptoms are and whether it is, for example, a dull pain, or of a different nature. The neurological examination includes sensory testing and reflexes. Sensory testing is done on both right and left sides for touch with a brush, a prick with a spur, and vibration with a tuning fork. Reflexes are tested for C4 (supraspinatus), 05 (biceps), C6 (brachioradialis), C7 (triceps), TiO (abdominal reflex), L4 (patella), Si (achilles).

A magnetic camera examination may be made, where images are taken using magnetic fields and radio waves (no risk of radiation). The magnetic field affects electronic equipment and magnetic objects. Therefore, you should not be examined if you have electronic equipment or metal in your body (eg pacemaker, metal fragments). Dental implants and dental braces cause disturbances and can complicate the image interpretation, but if you have these you can still be examined with a magnetic camera. During a regular examination, about 100-500 pictures are taken and the examination itself takes 20-45 minutes. "

The source of this info is the Ethical Review Authority application.
 
Inclusion criteria: "Participants are recruited consecutively among adult patients referred to ME Center (n = approximately 200).

Patients and controls will be asked in writing for consent to include the results of the examinations in the study, when receiving letters and forms from ME Center before their first enrollment visit."

The source of this info is the Ethical Review Authority application.

mango's note: No mention of diagnostic criteria in this section, unfortunately.
 
"The assumption underlying the study is that within the ME/CFS cohort there is a significant group of patients with changes in upper and/or lower neck joints that express themselves as neurological abnormalities."

The source of this info is the Ethical Review Authority application.
 
"The research questions are:

1. To what extent do neurological disorder findings from the cervical spine occur in patients referred for investigation of ME/CFS?

2. What is the correspondence between diagnosis of nerve impact on symptoms and neurological examination?

3. What is the correspondence between diagnosis of nerve impact based on the complaints sketch and a MRI of the cervical spine?

4. What interpersonal reliability does the complaints sketch have in screening for nerve impact in the cervical spine?

5. Are there differences between men/women regarding correspondence between the complaints sketch and neurological examination and MRI?"
mango's notes: Again, translated with the help of Google under the influence of PEM, so please be aware that there might be mistakes...

The source of this info is the Ethical Review Authority application, which is not published online as far as I know. But I'd be happy to share the document, feel free to ask and I'll send you a copy.
 
lansbergen said:
They might be on something there. When I was still severe that area was horrible.
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It will be very interesting to see where this leads. Are they really on to something, or is it a case of "if all you have is a hammer, everything looks like a nail"? BCB is new to ME, his background is in neck and back related pain

https://ki.se/en/people/bochbe
 
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lansbergen said:
Does he follow mainstream or does he have good ideas?
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I don't know, I've never talked to him myself and I haven't been able to find much at all online about his thoughts on ME.

There's been a few news articles the last few days, about a Swedish woman diagnosed with EDS, CCI and ME, where he has been quoted. She went to London for a special kind of standing MRI, then to a doctor in Barcelona who diagnosed her with CCI, and she is now fundraising for surgery in Barcelona.

Aftonbladet Google Translate said:
- Until we have learned to diagnose an injury or illness with reliable methods, the condition is often classified as something partially psychological. If we do not diagnose a physical problem, treatment is not offered for it either. Research is needed to improve our diagnostic methods, otherwise the problem remains a catch-22, says Bo Bertilson, doctor and pain scientist at Karolinska Institutet.
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https://www.aftonbladet.se/nyheter/a/vm4Ay4/robyn-29-sangliggande-pa-grund-av-svara-sjukdomen/promo

SVT Google Translate said:
- Unfortunately, there is great uncertainty both in terms of the diagnostic process and the treatment of patients with neck problems, he says.

Bo Bertilsson proposes a new type of overall assessment that should identify and help patients with neck injuries better.

- First, the patient will describe his/her complaints through questionnaires, and this can be done at home or at 1177 [online healthcare website]. Secondly, the healtcare provider must do a structured clinical examination and, if necessary, image diagnosis. Thirdly, the data that health care providers and patients collect should end up in a national register that can be used for research. In this way we can see which treatment works best in the long run.

Do we need to load MRI and DMX X-rays in Sweden?

- In my opinion, we need it as an aid in addition to careful clinical examinations. There are things that you can see on them that doesn't appear on a regular X-ray.
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https://amp.svt.se/nyheter/inrikes/lakare-okunskap-om-nackskador-i-sverige

Here's another article about her (no BCB quotes, though):
https://www.svt.se/nyheter/lokalt/s...as-i-spanien-ingreppet-erbjuds-inte-i-sverige
 
I have never got my head around the various seemingly unconnected suggestions of links between ME and cranio-spinal anomalies: problems with the joint between the spine and the skull impacting on the brain stem, hyper mobility perhaps impacting on the same joint, leakage of cerebrospinal fluid, misalignment in specific cervical vertebrae, that specific (thoracic?) spinal anomalies can be used to diagnose ME, etc.

Because I do not fully understand these ideas I may have confused details.

Is there enough evidence that we should be taking any of these seriously? Presumably BCB thinks there is something relevant about the interaction between the neck vertebrae and the associated spinal nerves.
 
Peter Trewhitt said:
I have never got my head around the various seemingly unconnected suggestions of links between ME and cranio-spinal anomalies: problems with the joint between the spine and the skull impacting on the brain stem, hyper mobility perhaps impacting on the same joint, leakage of cerebrospinal fluid, misalignment in specific cervical vertebrae, that specific (thoracic?) spinal anomalies can be used to diagnose ME, etc.

Because I do not fully understand these ideas I may have confused details.

Is there enough evidence that we should be taking any of these seriously? Presumably BCB thinks there is something relevant about the interaction between the neck vertebrae and the associated spinal nerves.
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I suspect it would be a symptom and not a cause of ME. You get ME, muscles weaken, joints are affected which can both lead to secondary symptoms maybe even leading to tertiary symptoms.
Just a theory.
That said there may also be overlap since this abnormality itself can apparently cause symptoms that get people misdiagnosed as having ME

We really need a disease mechanism/biomarker to start filtering out other conditions.
 
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Peter Trewhitt said:
I have never got my head around the various seemingly unconnected suggestions of links between ME and cranio-spinal anomalies: problems with the joint between the spine and the skull impacting on the brain stem, hyper mobility perhaps impacting on the same joint, leakage of cerebrospinal fluid, misalignment in specific cervical vertebrae, that specific (thoracic?) spinal anomalies can be used to diagnose ME, etc.

Because I do not fully understand these ideas I may have confused details.

Is there enough evidence that we should be taking any of these seriously? Presumably BCB thinks there is something relevant about the interaction between the neck vertebrae and the associated spinal nerves.
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Me too, seems like strange questions.
 
mango said:
There's been a few news articles the last few days, about a Swedish woman [...]
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One more article today, with a quote by the owner of Bragée ME Center (the clinic where the MED Study takes place):
Expressen said:
The doctor advises not to go

Swedish pain doctor Björn Bragée at Bragee Clinics, where Robyn Anborg was treated, has told Expressen that he discourages her from the surgery, among other things because of the risks.

- We have many examples of people [mango: I'm not sure what he means by the next words "blivit bra", it's unclear. Symptom free? Recovered completely? Significant improvement? Something else?], but that does not mean that everyone will. One can think of it as a kind of experimental surgery. The surgery involves all kinds of risks, says Bragée.
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https://www.expressen.se/gt/matilda-26-tillbaka-pa-sjukhuset-efter-blodpropp/

It also says that the surgery in Barcelona will cost approx 800 000 SEK (75 800 EUR, 85 700 USD).
 
Background: At the Bragée ME-Center, where the PhD students work, evaluations are offered to sick patients with possible myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) referred from all of Sweden. ME/CFS affects about 1% of Americans and can be defined as debilitating fatigue and widespread pain for 6 months in the absence of systemic disease. Common associated disorders are fibromyalgia, irritable bowel syndrome (IBS) and chronic symptoms after head and neck trauma. The cause of ME/CFS is still not known. ME/CFS shall be managed primarily within primary care according to Stockholm County Council guidelines, through a thorough medical history, physical examination and laboratory tests. However, current processes are often not structured enough and ME/CFS can be psychologized to the disadvantage of patients.

Aim: The overall aim of the PhD project is to make a contribution to the development of improved management and diagnostic process in primary care for ME/CFS and its associated disorders, and the goal is to reduce patient suffering and health care costs. Other aims are to describe the occurrence of cervical nerve affection among patients who are investigated for ME/CFS; to examine the usability of a discomfort drawing as a diagnostic tool to identify instability/nerve affection; to examine to what extent characteristic radiological findings can be identified for ME/CFS and its associated disorders. Project benefits are that a pain analysis will be made more frequently and in a more structured way for these patients. Eventually this can get the right treatment as soon as possible to people with chronic and hard to treat conditions.

Methods: The project is a clinical study with research questions mainly related to the extent of occurrence of cervical nerve affection among patients referred for investigation at Bragée ME-Center. Study variables are those included in the clinic’s regular assessment, such as the area of symptoms and quality of life (measured with discomfort drawing and EQ5D respectively), and structural changes in the cervical spine (measured with MRI).
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https://staff.ki.se/people/gabber
 
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