Elosan Efficacy Study (EES)

Elosan

Status

Completed

Conditions

Chronic Pain

Treatments

Device: Elosan Cabin

Study type

Interventional

Funder types

Industry

Identifiers

NCT03823729

ELO-02-17

Details and patient eligibility

About

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.

Full 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.

Enrollment

39 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.