Clinical Trial to Monitor the Efficacy of the Elosan Treatment by Applying Electrostatic

Elosan

Status: Completed

Conditions: Chronic Pain

Treatments: Device: Pain treatment by electrostatic charge to the whole body

Study type: Observational

Funder types: Industry

Identifiers

NCT04818294

ELES_03

Details and patient eligibility

About

The Treatment Cabin 'Elosan cabin' is a closed, electrically insulated cabin for the short-term application of a high electrostatic voltage to the body of patients with chronic pain.

Patients assigned will have 8 sessions in the treatment cabin, with an interval of 6 days between sessions. The existing therapies and painkillers will be continued at the discretion of the doctor.

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 electric charge is created by a generator which can produce a high electrostatic field. The electrical voltage is delivered to the hands via a metal handle and is spread over the entire body surface. After the short treatment, the patient is completely discharged and earthed again.

Over 100 patients in eight pain centers are to be included into this trial in order to show a statistically significant reduction of pain.

Enrollment: 192 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 ≥ 3 months
• Suffering from chronic pain
• Intensity of pain rated ≥ 50 mm on VAS pain

Exclusion criteria

• Patients with an electrical or electronic implant.
• Women who are pregnant, breastfeeding or planning to become pregnant
• Patients who have already been treated with the cabin within the last 4 weeks.
• Patients who are currently participating in other studies or who have participated in other studies in the last 30 days
• Patients who have indicated their intention or who are suspected of intending to discontinue or discontinue therapy before the end of the study