Elosan Efficacy Study (EES)

NCT ID: NCT03823729

Last Updated: 2019-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-18
• Study Completion Date: 2019-03-01

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.

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.

Conditions

Chronic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Elosan Cabin

Treatment with Elosan cabin

Group Type: EXPERIMENTAL

Elosan Cabin

Intervention Type: 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.

No Treatment

Continuation of taking pain medication as prescribed before study start.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Elosan AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Polymedes Pain Center

Bad Ragaz, CH, Switzerland

Centro Ortho-Bio-Med

Roveredo, CH, Switzerland

Zentrum für Neurochirurgie Hirslanden Ostschweiz

Sankt Gallen, CH, Switzerland

Countries

Switzerland

Other Identifiers

ELO-02-17

Identifier Type: -

Identifier Source: org_study_id