Clinical Trial to Monitor the Efficacy of the Elosan Treatment by Applying Electrostatic

NCT ID: NCT04818294

Last Updated: 2023-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

192 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-16

Study Completion Date

2022-06-15

Brief Summary

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The Treatment Cabin 'Elosan cabin' is a closed, electrically insulated cabin for the short-term application of a high electrostatic voltage to the body of patients with chronic pain.

Patients assigned will have 8 sessions in the treatment cabin, with an interval of 6 days between sessions. The existing therapies and painkillers will be continued at the discretion of the doctor.

Detailed Description

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Included in the study can be all persons suffering from chronic pain as it is often the case with rheumatic disease or traumata. The electric charge is created by a generator which can produce a high electrostatic field. The electrical voltage is delivered to the hands via a metal handle and is spread over the entire body surface. After the short treatment, the patient is completely discharged and earthed again.

Over 100 patients in eight pain centers are to be included into this trial in order to show a statistically significant reduction of pain.

Conditions

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Chronic Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Pain treatment by electrostatic charge to the whole body

Study Type is Observational as participants in the study receive therapeutic interventions in the therapy cabin as part of routine medical care and a researcher studies the effect of the intervention.

The study includes all persons who are already receiving therapy in the mentioned facilities, no external, specifically selected persons, but existing patients suffering from chronic pain who meet the specified conditions.

The therapy aims to alleviate chronic pain by applying an electrostatic charge of 50'000 Volt to the whole body in the special, electrically insulated cabin. The treatment is done upon the instructions of a physician. It is done with the patient standing up in the treatment cabin. The person is charged and discharged several times over the course of 2x 4 minutes. The charge can be felt on the skin and it can be seen through bristling of the hairs on the body. This treatment is repeated once a week.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Informed Consent
* adults, age ≥ 18 years, male or female patients
* History of pain ≥ 3 months
* Suffering from chronic pain
* Intensity of pain rated ≥ 50 mm on VAS pain

Exclusion Criteria

* Patients with an electrical or electronic implant.
* Women who are pregnant, breastfeeding or planning to become pregnant
* Patients who have already been treated with the cabin within the last 4 weeks.
* Patients who are currently participating in other studies or who have participated in other studies in the last 30 days
* Patients who have indicated their intention or who are suspected of intending to discontinue or discontinue therapy before the end of the study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Elosan AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stephan Steinhauser, M.D.

Role: PRINCIPAL_INVESTIGATOR

Stadtspital Triemli, 8063 Zürich

Locations

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Centro Ortho-Bio-Med

Roveredo, CH, Switzerland

Site Status

Zentrum für Neurochirurgie Hirslanden Ostschweiz

Sankt Gallen, CH, Switzerland

Site Status

Medizinisches Zentrum

Bad Ragaz, , Switzerland

Site Status

Spital Emmental, Schmerzzentrum

Burgdorf, , Switzerland

Site Status

Rheumapraxis Cham Zug

Cham, , Switzerland

Site Status

Praxis Dr. Kessler

Lucerne, , Switzerland

Site Status

Orthopädische Schmerztherapie Zürich

Zurich, , Switzerland

Site Status

Schulthess Klinik Zürich

Zurich, , Switzerland

Site Status

Countries

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Switzerland

References

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Steinhauser S, Ganter MT, Stadelmann V, Hofer CK; ELES Study Group. Whole-Body Electrostatic Pain Treatment in Adults with Chronic Pain: A Prospective Multicentric Observational Clinical Trial. Pain Ther. 2024 Feb;13(1):69-85. doi: 10.1007/s40122-023-00560-8. Epub 2023 Nov 28.

Reference Type DERIVED
PMID: 38015366 (View on PubMed)

Other Identifiers

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ELES_03

Identifier Type: -

Identifier Source: org_study_id

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