Chronic PainNCT04818294
Clinical Trial to Monitor the Efficacy of the Elosan Treatment by Applying Electrostatic
An observational study of Chronic Pain, run by Elosan AG at 8 sites in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Pain treatment by electrostatic charge to the whole body
- Type of treatment
- Medical device
- How many people
- 192 participants
- Where
- 8 sitesSwitzerland
- Study dates
- 16 Mar 2021to 15 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will include pain patients who are already being treated in the practice of clinical or resident pain therapy facilities.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Switzerland8 sites
Medizinisches Zentrum
Bad Ragaz, 7310
Spital Emmental, Schmerzzentrum
Burgdorf, 3400
Rheumapraxis Cham Zug
Cham, 6330
Praxis Dr. Kessler
Lucerne, 6006
Centro Ortho-Bio-Med
Roveredo, CH, 6535
Zentrum für Neurochirurgie Hirslanden Ostschweiz
Sankt Gallen, CH, 9016
Orthopädische Schmerztherapie Zürich
Zurich, 8003
Schulthess Klinik Zürich
Zurich, 8063
About this study
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.
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.
Read the 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.
- Conditions
- Chronic Pain
- Being tested
- Pain treatment by electrostatic charge to the whole body
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain treatment by electrostatic charge to the whole bodyDevice
Study Type is Observational as participants in the study receive therapeutic interventions in the therapy cabin as part of routine medical care and a researcher studies the effect of the intervention.
The study includes all persons who are already receiving therapy in the mentioned facilities, no external, specifically selected persons, but existing patients suffering from chronic pain who meet the specified conditions.
The therapy aims to alleviate chronic pain by applying an electrostatic charge of 50'000 Volt to the whole body in the special, electrically insulated cabin. The treatment is done upon the instructions of a physician. It is done with the patient standing up in the treatment cabin. The person is charged and discharged several times over the course of 2x 4 minutes. The charge can be felt on the skin and it can be seen through bristling of the hairs on the body. This treatment is repeated once a week.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8-9 weeks
Secondary outcomes (2)
Composite outcome physical health (PCS) and mental health (MCS) to determine the quality of life assessed by the SF-12 Questionnaire
Patients fill out a 12 question survey at the first and the last visit, which is then scored by a researcher.
The 12-Item Short Form Survey (SF-12) is designed as a general measure of health. It is a quality of Well-Being Score in comparison to US general population. Composite outcome physical health (PCS) and mental health (MCS) to determine the quality of life assessed by SF-12 Questionnaire compared to the United States average (avg=50)
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.
Measured: 8-9 weeks
Pain medication / therapy and any changes thereof shall be recorded during the study.
To determine the effects on standard treatment, medication and other, different therapies, a special questionnaire is collected per patient.
This lists the dose of all medications and therapies as follows:
- until the start of the study
- at each of the 8 visits
- at the end of the study
Medication will vary from patient to patient. Therefore, the dose of comparable medications/therapies, mainly pain medications, will be assessed.
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.
Measured: 8-9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start16 Mar 2021
- Primary completion15 May 2022
- Study completion15 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elosan AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephan Steinhauser, M.D., Principal investigator, Stadtspital Triemli, 8063 Zürich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04818294
- Sponsor's protocol ID
- ELES_03
- Status last verified
- Jan 2023
- First submitted
- 19 Mar 2021
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Steinhauser S, Ganter MT, Stadelmann V, Hofer CK; ELES Study Group. Whole-Body Electrostatic Pain Treatment in Adults with Chronic Pain: A Prospective Multicentric Observational Clinical Trial. Pain Ther. 2024 Feb;13(1):69-85. doi: 10.1007/s40122-023-00560-8. Epub 2023 Nov 28.
PubMed 38015366
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04818294
- Acronym / sponsor ID
- ELES_03
- Conditions
- Chronic Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Elosan AGIndustry (pharma, biotech, devices)
- Study start
- 16 Mar 2021 (actual)
- Primary completion
- 15 May 2022 (actual)
- Study completion
- 15 Jun 2022 (actual)
- First posted
- 26 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include pain patients who are already being treated in the practice of clinical or resident pain therapy facilities.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pain treatment by electrostatic charge to the whole bodyStudy Type is Observational as participants in the study receive therapeutic interventions in the therapy cabin as part of routine medical care and a researcher studies the effect of the intervention. The study includes all persons who are already receiving therapy in the mentioned facilities, no external, specifically selected persons, but existing patients suffering from chronic pain who meet the specified conditions. The therapy aims to alleviate chronic pain by applying an electrostatic charge of 50'000 Volt to the whole body in the special, electrically insulated cabin. The treatment is done upon the instructions of a physician. It is done with the patient standing up in the treatment cabin. The person is charged and discharged several times over the course of 2x 4 minutes. The charge can be felt on the skin and it can be seen through bristling of the hairs on the body. This treatment is repeated once a week. | Device | – |
Primary outcome
Change of Pain Intensity is being assessed by Visual Analogue Scale (VAS)
Time frame: 8-9 weeks
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.
2 secondary outcomes
Composite outcome physical health (PCS) and mental health (MCS) to determine the quality of life assessed by the SF-12 Questionnaire
Time frame: 8-9 weeks
Pain medication / therapy and any changes thereof shall be recorded during the study.
Time frame: 8-9 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
- Derived from this study: PubMed 38015366Steinhauser S, Ganter MT, Stadelmann V, Hofer CK; ELES Study Group. Whole-Body Electrostatic Pain Treatment in Adults with Chronic Pain: A Prospective Multicentric Observational Clinical Trial. Pain Ther. 2024 Feb;13(1):69-85. doi: 10.1007/s40122-023-00560-8. Epub 2023 Nov 28.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephan Steinhauser, M.D. principal investigator
Stadtspital Triemli, 8063 Zürich
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain, run by Elosan AG at 8 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Pain Intensity is being assessed by Visual Analogue Scale (VAS) (time frame: 8-9 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04818294, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2023.