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

Prospective, Multi-center, Clinical Trial (Phase IV Study) to Monitor the Efficacy of Treatment by Applying a High Electrostatic Charge to Patients With Chronic Pain, in the Practice of Clinical or Out-patient Pain Treatment Facilities.

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Device: Pain treatment by electrostatic charge to the whole body

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 192

Contacts and Locations

Study Locations

• Switzerland
  • Bad Ragaz, Switzerland, 7310
    • Medizinisches Zentrum
  • Burgdorf, Switzerland, 3400
    • Spital Emmental, Schmerzzentrum
  • Cham, Switzerland, 6330
    • Rheumapraxis Cham Zug
  • Luzern, Switzerland, 6006
    • Praxis Dr. Kessler
  • Zürich, Switzerland, 8003
    • Orthopädische Schmerztherapie Zürich
  • Zürich, Switzerland, 8063
    • Schulthess Klinik Zürich
  • CH
    • Roveredo, CH, Switzerland, 6535
      • Centro Ortho-Bio-Med
    • St.Gallen, CH, Switzerland, 9016
      • Zentrum für Neurochirurgie Hirslanden Ostschweiz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite outcome physical health (PCS) and mental health (MCS) to determine the quality of life assessed by the SF-12 Questionnaire	Patients fill out a 12 question survey at the first and the last visit, which is then scored by a researcher. The 12-Item Short Form Survey (SF-12) is designed as a general measure of health. It is a quality of Well-Being Score in comparison to US general population. Composite outcome physical health (PCS) and mental health (MCS) to determine the quality of life assessed by SF-12 Questionnaire compared to the United States average (avg=50) The change in quality of life (as reported by SF 12 questionnaires) from baseline to end of treatment (Day 28) will be compared between the treatment groups. The impact of the changes in summary scores (NBS: Norm-Based-Scoring) of physical health (PCS) and mental health (MCS) will be assessed by a General Linear Model (GLM) using the treatment as fixed factors and the baseline PCS and MCS as covariates, respectively.	8-9 weeks
Pain medication / therapy and any changes thereof shall be recorded during the study.	To determine the effects on standard treatment, medication and other, different therapies, a special questionnaire is collected per patient. This lists the dose of all medications and therapies as follows: until the start of the study; at each of the 8 visits; at the end of the study Medication will vary from patient to patient. Therefore, the dose of comparable medications/therapies, mainly pain medications, will be assessed. The pain medication taken at baseline will be compared to the amount of pain medication taken at the end of treatment. Changes in pain medication will be qualified by the investigators as either being clinically relevant or not.	8-9 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improving the quality of sleep	The quality of sleep is recorded on the questionnaire at each visit	8-9 weeks

Collaborators and Investigators

• Sponsor: Elosan AG
• Investigators: Principal Investigator: Stephan Steinhauser, M.D., Stadtspital Triemli, 8063 Zürich

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2021
• Primary Completion (Actual): May 15, 2022
• Study Completion (Actual): June 15, 2022

Study Registration Dates

• First Submitted: March 19, 2021
• First Submitted That Met QC Criteria: March 25, 2021
• First Posted (Actual): March 26, 2021

Study Record Updates

• Last Update Posted (Estimate): January 26, 2023
• Last Update Submitted That Met QC Criteria: January 25, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: ELES_03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No