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A new tool for multimodal pain treatment

The Elosan C1 cabin is a Class IIa medical device. It complements today's usual pain therapies and is used as an adjunct to multimodal, primarily drug-based treatments.

 

Multimodal pain treatment is the current, scientifically proven treatment for chronic pain conditions. Elosan therapy complements this treatment.

Medical purpose

Medical purpose

The treatment aims to alleviate chronic pain – especially soft-tissue rheumatic pain and other rheumatic pain – by applying a high electrostatic charge to the whole body.

The aim of treatment with the Elosan Cabin is therefore to:

  • significantly reduce the chronic and acute pain that often occurs in the case of rheumatic disease or trauma;
  • improve quality of life and reduce the need for pain medication.

The therapy complements a pain therapy that is common today. It is used as an adjunct to a multimodal, but above all drug-based treatment.

Applications – Indication

Elosan therapy is used to treat almost any type of chronic pain. It also helps treat acute pain and prevent it becoming chronic when used as an innovative physical tool to complement ongoing conservative, multimodal pain treatment concepts. Chronic pain conditions can be caused by a variety of causes. The most common forms of chronic pain are:

  • Back pain
  • Rheumatic pain
  • Neuropathic pain
  • Fibromyalgia (soft-tissue rheumatism)
  • Degenerative pain
  • Headaches
  • Phantom pains

Various investigations have also shown efficacy in acute musculoskeletal pain. Cervical spine, lumbar spine and shoulder-arm syndromes are conditions where this treatment is showing particular promise.

Contraindication

All types of electrical or electronic implants, such as:

  • Pacemakers
  • Defibrillators
  • Implantable cardioverter defibrillators
  • Electrical pumps such as insulin pumps.

Untreated seizure disorders are another strict contraindication. For a full list of warnings and instructions, please refer to the instructions for use.

Physiological aspects

Physiologische Aspekte

The force of the electrical field acting on free electrical charge carriers results in a movement of charge. It can be assumed that when a very strong electrostatic DC field surrounds the body, as in the case in the Elosan Cabin, this has an effect that extends into the outer layers of the skin where the nociceptors are embedded and down into the underlying cells of the connective tissue.

Depending on the charge of the ions, this force can have either an inhibitory or an accelerating effect on ion movements. Therefore, it can influence both resting membrane potential and the development and conduction of action potentials (e.g. in nerve cells).

This could explain the effect on pain observed in tests to date: the physical action of this force could affect the stimulation of the nociceptors or it could affect the conduction of action potentials in nerve cells.

Placement and space requirements

Placement and space requirements

The cabin can be placed in any area of a practice or clinic. The space used for the treatment should be well lit and adequately temperature-controlled. An air humidity of over 30% RH and under 80% RH should be aimed for.

There should be a standard socket with 120 AC volts or 230 AC volts as close to the cabin as possible. The required connected rating is only about 50 watts. Ideally, the cabin should be placed in a corner so that it takes up as little space as possible. The space required is approximately 2.20 metres by 2.20 metres. The cabin’s height is 2.30 metres.

The cabin is delivered in the form of pre-assembled components and it is assembled and put into operation by Elosan AG service technicians or other professionals with the required training. After assembly, the operators are trained in how to use it.

The Elosan therapy treatment process

The Elosan therapy treatment process

  1. The patient wears light, dry clothes and outdoor shoes. Their hands should also be washed.
  2. The patient enters the cabin through the door on the side and stands in the middle of the cabin.
  3. The operator ensures that the patient is holding the handle with both hands.
  4. The cabin has transparent areas so that the patient can be monitored throughout the entire treatment session. The automatic treatment sequence repeats until three charging cycles are complete. This is followed by discharging to earth potential.
  5. The process can be stopped at any time by turning the rotating switch or by opening the door.

A single treatment session takes eight minutes. In practice, around four patients can be treated per hour.

Method of application

Method of application

Because treatment with the Elosan Cabin is so new, operators must take care when using it. It is important to bear in mind that patients may have some fear of the “electrical” aspect and may also feel anxious about being treated in a closed cabin. Furthermore, as with many medications, this electro-physical treatment method should be expected to have a non-responder rate of 30%. The following treatment regimen has been established based on experience gained from treatments carried out during the development of the Elosan Cabin:

Start  
Two treatments per week for two to three weeks

After four to six treatments
Assessment 1, basic efficacy:

  • Responder
  • Non-responder (a non-responder is a person who has no improvement after three to five treatments)

Assessment of the responder
Assessment 2, with patients who responded positively to the treatment:

  • Intensity of the effect: 
     alleviation of pain/absence of pain
  • Tolerability of the effect: 
    side effects/no side effects
  • Other changes, such as:
    general well-being, changes in physical performance or better sleep

Continuation of treatments
Continuation of treatments as follows:

  • One treatment per week or
  • Block treatments, for instance 10 treatments within five weeks and then a longer break from treatment

Special considerations
For some chronic pain conditions, continuous treatment one or two times a week has proven effective.

Efficacy of the treatment

Studies and publications

For the approval as a medical device as well as in the framework of the PMCF, various studies were conducted to clarify efficacy, safety and mechanism of action. 

A first clinical study on a chronic pain population confirms a good efficacy in the reduction of various chronic pain symptoms. Based on this, the clinical follow-up study in 8 centres shows similarly good results.

Elosan therapy does indeed have a positive impact on pain experience in different chronic pain conditions, which is very encouraging considering the treatment resistance of chronic pain. Given the current precarious social and economic impact of chronic pain disorders, effective, low-cost and low side-effect alternative treatment modalities are of utmost relevance.

The additional challenge is that due to the novelty of the treatment modality, no systematic basic studies exist yet regarding the underlying mechanisms of action. The Innosuisse project is therefore conducting a systematic investigation into the mechanism of action.

Comment by the principal investigator of the pivotal study

"The treatment with the Elosan therapy cabin C1 expands the spectrum of therapy options for patients with chronic and acute pain by an effective, side-effect-free, well-tolerated and non-medicinal physical treatment option. The therapy is time-saving, can be delegated and is not stressful or dangerous for the patients."

Petra Hoederath, MD
Head of Multimodal Pain Therapy
Hirslanden Clinic Stephanshorn, St.Gallen

 

Elosan effacy

2021-2022, Clinical trial NCT04818294
8 centres with 143 patientsProspective, non-interventional, multicentre, clinical trial (phase IV study) to monitor the efficacy of treatment with the Elosan cabin in patients with chronic pain, in the practice of clinical or private practice pain management facilities.

2021-2022, Innosuisse 51821.1 IP-LS, Uni Zurich
100 subjects and exploratively 80 patients 
In cooperation with the University of Zurich, the critical question of the fundamental influence of the electrostatic field on the healthy human body is being researched. Effects on three levels are investigated, namely: peripheral-physiological, neuro-physiological and behavioural.

2018-2019, EUDAMED registration study no. CIV-18-01-022865
3 centres with 42 patients
Randomised, open-label, comparative clinical trial to demonstrate the efficacy of a short-term, whole-body, high-voltage electrostatic application for the relief of chronic pain. The study can include anyone suffering from chronic pain, as is often the case with rheumatic diseases or trauma.

2017-2018, exploratory feasibility studies.
36 and 18 patients
Individuals with spinal syndromes, polyneuropathy, rheumatic pain as well as post operative pain were included. Significant improvement was achieved in patients in the studies.

1980-1981, explorative studies by the inventor Dr. B. Reinhardt
17 patients
The patients treated were largely free of pain. The treatment frequency was between 2 and 14 individual treatments (3 x 20 sec.). The diseases were cervical and lumbar spine syndrome and gonarthrosis/arthritis.

Publications

Publication of the clinical study by Springer Verlag in January 2020

The editors at Springer Verlag have now approved the clinical study for publication. It is now available online and has been published as follows:

a) Print media: scientific journal «Der Schmerz», issue 1/2020, February 2020
b) Springer «Online First» article
c) PubMed

Innosuisse research project

Cooperation with the University of Zurich

Together with scientists from the University of Zurich, Elosan AG has submitted a research project to Innosuisse, the Swiss Agency for Innovation Promotion. The innovation project "Neurobiological effect of the Elosan electrostatic application" is primarily intended to scientifically investigate the mechanism of action of the Elosan therapy.

We are very proud that the Innosuisse grant application was approved in September 2021. It confirms our work and will support us in developing a scientific basis. Neuroscientists are to research and scientifically prove the mechanisms of action of the application of an electrostatic high voltage.

Investigation of the influence of the electrostatic field on the human body

The cabin, developed by Elosan AG and approved by TÜV Rheinland, works through the application of 50,000 volt strong electrostatic fields. Its effectiveness is shown in studies on chronic pain patients and also achieves an improvement in sleep, general well-being and vitality. Unfortunately, very little is known about the actual mechanisms of action. What exactly happens in the body through the electrostatic high voltage on the skin?

In cooperation with the University of Zurich, this question, which is critical for market success, is now being addressed: what is the fundamental influence of the electrostatic field on the healthy human body? Effects are being investigated on three levels, namely: peripheral physiological, neuro-physiological and behavioural. This provides Elosan AG with a scientifically sound basis of argumentation for the mechanisms of action of the application of an electrostatic high voltage. This information supports a possible extension of the field of application and our requests for reimbursement by health insurance companies.

Innosuisse project no. 51821.1: "Neurobiological effect of the Elosan electrostatic application".

Integrating the Elosan Cabin into your pain treatment concept

Ease of use

Treatment using the Elosan Cabin is a new treatment. It is used by physicians, healthcare professionals or other professionals. The advantages of Elosan therapy are that the treatment is effective, does not take long, and is easy to carry out and easy to delegate. A single treatment session takes only four minutes. In practice, around six patients can be treated per hour.

The Elosan Cabin is an effective, electro-physical treatment for acute pain and – most especially – chronic pain. It is ideal for use as a treatment to complement interdisciplinary, multimodal treatment concepts.

Where Elosan therapy is used

Treatment with the Elosan Cabin is suitable for use in pain clinics, pain treatment centres or specialist outpatient pain clinics as an effective, quick, cost-effective physical component to complement any pain treatment concept.

Pain treatment centres at university hospitals
Pain treatment centres at university hospitals that are prepared to incorporate Elosan therapy into their scientific concepts and clinical studies and publish about this can procure the cabin under very favourable terms.

Regional pain treatment centres
As a physical component of treatment that has no side effects, a treatment method like Elosan therapy is the perfect addition to the range of treatments on offer at regional pain treatment centres.

Medical practices and outpatient pain clinics
Treatment with the Elosan Cabin is the perfect complementary addition to standard treatment. It is used alongside standard treatment with the expectation that the use of medications can be reduced.

Costs, benefits and return on investment

As a new component of pain treatment, the Elosan Cabin is not yet widely known about. It is therefore not yet included in the treatment catalogues of statutory health insurance providers. Consequently, patients themselves are billed for this treatment.

Since it is considered an individual healthcare service (“individuelle Gesundheitsleistung” or “IGeL”), with a sufficient number of treatments, the Elosan Cabin offers those interested in offering it as a treatment a good cost-benefit ratio, plus it pays for itself relatively quickly. In addition, Elosan therapy is easy to delegate.

The cost of procuring the Elosan Cabin is moderate and very reasonable. There are various customisable options available: outright purchase, hire purchase or hire.

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