Chronic Pain Clinical Trial
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
NCT number | NCT03823729 |
Other study ID # | ELO-02-17 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 18, 2018 |
Est. completion date | March 1, 2019 |
Verified date | March 2019 |
Source | Elosan AG |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 39 |
Est. completion date | March 1, 2019 |
Est. primary completion date | March 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Switzerland | Polymedes Pain Center | Bad Ragaz | CH |
Switzerland | Centro Ortho-Bio-Med | Roveredo | CH |
Switzerland | Zentrum für Neurochirurgie Hirslanden Ostschweiz | St.Gallen | CH |
Lead Sponsor | Collaborator |
---|---|
Elosan AG |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Change in quality of life is being assessed by SF 12 Questionnaire (The 12-Item Short Form Health Survey) | The change in quality of life (as reported by SF 12 questionnaires) from baseline to end of treatment (Day 28) will be compared between the treatment groups. The impact of the changes in summary scores (NBS: Norm-Based-Scoring) of physical health (PCS) and mental health (MCS) will be assessed by a General Linear Model (GLM) using the treatment as fixed factors and the baseline PCS and MCS as covariates, respectively. | Change from Baseline at 4 weeks | |
Secondary | Pain medication / pain therapy and any changes thereof shall be recorded during the study. | The pain medication taken at baseline will be compared to the amount of pain medication taken at the end of treatment. Changes in pain medication will be qualified by the investigators as either being clinically relevant or not. | before and after 4 weeks of treatment |
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