Elosan Efficacy Study (EES)

A Randomized, Open, Comparative Clinical Investigation to Show the Efficacy of a Short Time, Whole Body, Electrostatic High Voltage Application for Relief of Chronic Pain. Included in Study Can be Persons Suffering From Chronic Pain as it is Often Case With Rheumatic Disease or Traumata

The "Elosan Cabin" is a closed, electrically insulated, biocompatible cabin for the short-term application of electrostatic high voltage in patients with chronic pain, especially those with rheumatic diseases. Patients assigned to the Elosan group (group A) will have 8 sessions in the Elosan cabin, with an interval of 3 to 4 days between sessions. Patients assigned to the control group (group B) will have no treatment except for the continuation of their prescribed pain medication and pain therapy.

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Device: Elosan Cabin

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 Elosan therapy to be investigated aims to treat chronic pain by applying an electrical charge to the body surface and by disruption of positive bio-feedback to restore physiological reflex relations between the periphery and the central regulation. The electric charge is created by a generator which can produce an electrostatic field. The electrical voltage is delivered to the hands via a metal handle in a closed cabin and is spread over the entire body surface.

A total number of 42 patients will be included into this trial in order to show a statistically significant reduction of pain compared to reduction of pain in the control group.

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • CH
    • Bad Ragaz, CH, Switzerland, 7310
      • Polymedes Pain Center
    • 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: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Informed Consent
• adults, age ≥ 18 years, male or female patients
• History of pain ≥ 6 months
• Suffering from chronic pain, either reumatic pain or pain caused by traumata
• Intensity of pain rated ≥ 50 mm on VAS pain

Exclusion Criteria:

• Untreated thyroid disease
• History of seizure disorder (epilepsy)
• History of or current psychosis
• Women who are pregnant, breast feeding or intending to become pregnant
• Patients who are currently participating in other studies or have participated in other studies within the last 30 days
• Patients who have expressed their intention, or are suspected of intending, to discontinue therapy or stop therapy before the end of trial
• Patients with an electric or electronic implant.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Elosan Cabin; Treatment with Elosan cabin	Device: Elosan Cabin; The Elosan Cabin is a closed, electrically insulated, biocompatible cabin for the short-term application of electrostatic high voltage. Patients assigned to the Group A will have 8 sessions in the Elosan cabin, with an interval of 3 to 4 days between sessions.
No Intervention: No Treatment; Continuation of taking pain medication as prescribed before study start.

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.	Change from Baseline Intensity of pain at 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in quality of life is being assessed by SF 12 Questionnaire (The 12-Item Short Form Health Survey)	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.	Change from Baseline at 4 weeks
Pain medication / pain therapy and any changes thereof shall be recorded during the study.	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.	before and after 4 weeks of treatment

Collaborators and Investigators

• Sponsor: Elosan AG

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2018
• Primary Completion (Actual): March 1, 2019
• Study Completion (Actual): March 1, 2019

Study Registration Dates

• First Submitted: January 25, 2019
• First Submitted That Met QC Criteria: January 29, 2019
• First Posted (Actual): January 30, 2019

Study Record Updates

• Last Update Posted (Actual): March 13, 2019
• Last Update Submitted That Met QC Criteria: March 12, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: ELO-02-17

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