Skip to main content
OpenTrials
Completed

NCT Number: NCT03823729

Elosan Efficacy Study (EES)

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Polymedes Pain Center, Bad Ragaz, CH, Switzerland

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Elosan Cabin

Device

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.

Primary outcomes

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

    Time frame: Change from Baseline Intensity of pain at 4 weeks

    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.

Secondary outcomes

  1. Change in quality of life is being assessed by SF 12 Questionnaire (The 12-Item Short Form Health Survey)

    Time frame: Change from Baseline at 4 weeks

    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.

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

    Time frame: before and after 4 weeks of treatment

    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.

Sponsors and collaborators

Lead sponsor

Elosan AG

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 30, 2019
Registry last updated
Mar 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.