Elosan Efficacy Study (EES)

• ClinicalTrials.gov Identifier: NCT03823729
• Recruitment Status: Completed
• First Posted: January 30, 2019
• Last Update Posted: March 13, 2019
• Sponsor: Elosan AG
• Information provided by (Responsible Party): Elosan AG

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Chronic Pain	Device: Elosan Cabin	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 39 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 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.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official 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
• Actual Study Start Date: July 18, 2018
• Actual Primary Completion Date: March 1, 2019
• Actual Study Completion Date: March 1, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Locations

Switzerland

Polymedes Pain Center

Bad Ragaz, CH, Switzerland, 7310

Centro Ortho-Bio-Med

Roveredo, CH, Switzerland, 6535

Zentrum für Neurochirurgie Hirslanden Ostschweiz

St.Gallen, CH, Switzerland, 9016

Sponsors and Collaborators

Elosan AG

More Information

• Responsible Party: Elosan AG
• ClinicalTrials.gov Identifier: NCT03823729
• Other Study ID Numbers: ELO-02-17
• First Posted: January 30, 2019
• Last Update Posted: March 13, 2019
• Last Verified: March 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Chronic Pain; Pain; Neurologic Manifestations