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

NCT04818294 | Completed

• 1 other identifier: ELES_03
• Study Type: observational
• Target: 192
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (1)

• Change of Pain Intensity is being assessed by Visual Analogue Scale (VAS)

  Change of Pain Intensity is being assessed on a horizontal 100 mm VAS (Visual Analogue Scale) pain scale. The total range of this scale is 100 mm. Minimum score is 0 mm, Maximum score is 100 mm. The higher values represent a higher intensity of pain. The values at baseline will be compared to the values at Visit 8 and the mean of the differences will be compared between the 2 treatment arms.

  8-9 weeks

Secondary Outcomes (2)

• Composite outcome physical health (PCS) and mental health (MCS) to determine the quality of life assessed by the SF-12 Questionnaire

  8-9 weeks

• Pain medication / therapy and any changes thereof shall be recorded during the study.

  8-9 weeks

Other Outcomes (1)

• Improving the quality of sleep

  8-9 weeks

Interventions

Pain treatment by electrostatic charge to the whole body DEVICE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study will include pain patients who are already being treated in the practice of clinical or resident pain therapy facilities.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Elosan AG: lead

Study Sites (8)

Centro Ortho-Bio-Med

Roveredo, CH, 6535, Switzerland

Location

Zentrum für Neurochirurgie Hirslanden Ostschweiz

Sankt Gallen, CH, 9016, Switzerland

Location

Medizinisches Zentrum

Bad Ragaz, 7310, Switzerland

Location

Spital Emmental, Schmerzzentrum

Burgdorf, 3400, Switzerland

Location

Rheumapraxis Cham Zug

Cham, 6330, Switzerland

Location

Praxis Dr. Kessler

Lucerne, 6006, Switzerland

Location

Orthopädische Schmerztherapie Zürich

Zurich, 8003, Switzerland

Location

Schulthess Klinik Zürich

Zurich, 8063, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 38015366 DERIVED

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Stephan Steinhauser, M.D.

  Stadtspital Triemli, 8063 Zürich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2021
• First Posted: March 26, 2021
• Study Start: March 16, 2021
• Primary Completion: May 15, 2022
• Study Completion: June 15, 2022
• Last Updated: January 26, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CH (8)