Elosan Efficacy Study (EES)

NCT03823729 | Completed

• 1 other identifier: ELO-02-17
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 3

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.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (1)

• Change of Pain Intensity is being assessed by Visual Analogue Scale (VAS).

  Change of Pain Intensity is being assessed on a horizontal 100 mm VAS (Visual Analogue Scale) pain scale. The total range of this scale is 100 mm. Minimum score is 0 mm, Maximum score is 100 mm. The higher values represent a higher intensity of pain. The values at baseline will be compared to the values at Visit 8 and the mean of the differences will be compared between the 2 treatment arms.

  Change from Baseline Intensity of pain at 4 weeks

Secondary Outcomes (2)

• Change in quality of life is being assessed by SF 12 Questionnaire (The 12-Item Short Form Health Survey)

  Change from Baseline at 4 weeks

• Pain medication / pain therapy and any changes thereof shall be recorded during the study.

  before and after 4 weeks of treatment

Study Arms (2)

Elosan Cabin

EXPERIMENTAL

Treatment with Elosan cabin

Device: Elosan Cabin

No Treatment

NO INTERVENTION

Continuation of taking pain medication as prescribed before study start.

Interventions

Elosan Cabin 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.

Elosan Cabin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Elosan AG: lead

Study Sites (3)

Polymedes Pain Center

Bad Ragaz, CH, 7310, Switzerland

Location

Centro Ortho-Bio-Med

Roveredo, CH, 6535, Switzerland

Location

Zentrum für Neurochirurgie Hirslanden Ostschweiz

Sankt Gallen, CH, 9016, Switzerland

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 25, 2019
• First Posted: January 30, 2019
• Study Start: July 18, 2018
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: March 13, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (3)