Clinical trial NCT03823729: Elosan Efficacy Study (EES)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Lead sponsor: Elosan AG
Sponsor class: INDUSTRY
First posted: 2019-01-30
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change of Pain Intensity is being assessed by Visual Analogue Scale (VAS).
timeFrame: Change from Baseline Intensity of pain at 4 weeks
Secondary outcomes:
measure: Change in quality of life is being assessed by SF 12 Questionnaire (The 12-Item Short Form Health Survey)
timeFrame: Change from Baseline at 4 weeks
measure: Pain medication / pain therapy and any changes thereof shall be recorded during the study.
timeFrame: before and after 4 weeks of treatment
Other outcomes:
Locations:
city: Bad Ragaz
country: Switzerland
facility: Polymedes Pain Center
state: CH
city: Roveredo
country: Switzerland
facility: Centro Ortho-Bio-Med
state: CH
city: St.Gallen
country: Switzerland
facility: Zentrum für Neurochirurgie Hirslanden Ostschweiz
state: CH
Study officials:
References: