Clinical trial NCT04818294: Clinical Trial to Monitor the Efficacy of the Elosan Treatment by Applying Electrostatic
Official title: Prospective, Multi-center, Clinical Trial (Phase IV Study) to Monitor the Efficacy of Treatment by Applying a High Electrostatic Charge to Patients With Chronic Pain, in the Practice of Clinical or Out-patient Pain Treatment Facilities.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain
Lead sponsor: Elosan AG
Sponsor class: INDUSTRY
First posted: 2021-03-26
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study will include pain patients who are already being treated in the practice of clinical or resident pain therapy facilities.

Brief summary: 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.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of Pain Intensity is being assessed by Visual Analogue Scale (VAS)
timeFrame: 8-9 weeks
Secondary outcomes:
measure: Composite outcome physical health (PCS) and mental health (MCS) to determine the quality of life assessed by the SF-12 Questionnaire
timeFrame: 8-9 weeks
measure: Pain medication / therapy and any changes thereof shall be recorded during the study.
timeFrame: 8-9 weeks
Other outcomes:
measure: Improving the quality of sleep
timeFrame: 8-9 weeks
Locations:
city: Roveredo
country: Switzerland
facility: Centro Ortho-Bio-Med
state: CH
city: St.Gallen
country: Switzerland
facility: Zentrum für Neurochirurgie Hirslanden Ostschweiz
state: CH
city: Bad Ragaz
country: Switzerland
facility: Medizinisches Zentrum
city: Burgdorf
country: Switzerland
facility: Spital Emmental, Schmerzzentrum
city: Cham
country: Switzerland
facility: Rheumapraxis Cham Zug
city: Luzern
country: Switzerland
facility: Praxis Dr. Kessler
city: Zürich
country: Switzerland
facility: Orthopädische Schmerztherapie Zürich
city: Zürich
country: Switzerland
facility: Schulthess Klinik Zürich
Study officials:
affiliation: Stadtspital Triemli, 8063 Zürich
name: Stephan Steinhauser, M.D.
role: PRINCIPAL_INVESTIGATOR
References: