Correlation between auricular diagnosis and abdominal symptoms- a pilot study
Organizational Data
- DRKS-ID:
- DRKS00030318
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2022-09-27
- Last update in DRKS:
- 2023-10-02
- Registration type:
- Retrospective
Acronym/abbreviation of the study
No Entry
URL of the study
No Entry
Brief summary in lay language
Paul Nogier, found in the 20th century that specific regions of the ear correspond to specific organ systems. He used this so-called neuronal synchronization to treat both musculoskeletal disorders and organ disorders. The somatotopy on the ear described by Nogier is to be examined more closely in this study. The main question here is whether patients with abdominal complaints also have correspondingly sensitive regions on the ear: Does the appendix point show tenderness in appendicitis? What about the gallbladder point in cholecystitis?
Brief summary in scientific language
As part of the CADAS study, consenting patients who come to the emergency room with abdominal complaints receive an auricular diagnosis. Here, in accordance to the somatotopy described by Nogier, the abdominal region on the ear is examined. Later, the correlation between the patient's diagnosis and the point determined on the ear is assessed? In the case of appendicitis, is the correlating appendix point in the ear described by Nogier also pressure sensitive? The auricular diagnosis is performed prior to medical diagnostical tools like imaging and surgical interventions.
Health condition or problem studied
- ICD10:
- R10.0 - Acute abdomen
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- test group: examining the most painful region in the ear. Upon presentation in the emergency department. Participants receive an examination of both ears. The most painful points are noted. After the diagnosis or therapeutic intervention has been completed, the correlation of the affected organ system with the noticeable point on the ear is examined.
Endpoints
- Primary outcome:
- Manual localization of the most painful region on the ear.
- Secondary outcome:
- Localization of other painful points on the ear and their correlation with the existing diagnosis. location of abdominal pain
Study Design
- Purpose:
- Diagnostic
- Retrospective/prospective:
- No Entry
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- No Entry
- Study type non-interventional:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- Medical center Universitätsklinik Mannheim Mannheim
Recruitment period and number of participants
- Planned study start date:
- No Entry
- Actual study start date:
- 2022-09-21
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2023-09-29
- Target Sample Size:
- 150
- Final Sample Size:
- 150
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- entering emergency department with abdominal pain
Exclusion Criteria
surgicial intervention within the last 30 days
Addresses
Primary Sponsor
- Address:
- Chirurgische Klinik Universitätsklinik MannheimTheodor-Kutzer-Ufer 1 - 368167 MannheimGermany
- Telephone:
- 0621 3830
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Chirurgische Klinik Universitätsklinik MannheimDr. med. Erfan GhanadTheodor-Kutzer-Ufer 1 - 368167 MannheimGermany
- Telephone:
- 0621 3830
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- Chirurgische KlinikUniversitätsklinik MannheimDr. med. Erfan GhanadTheodor-Kutzer-Ufer 1-368167 MannheimGermany
- Telephone:
- 0621 3830
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- Chirurgische Klinik Universitätsklinik MannheimDr. med. Erfan GhanadTheodor-Kutzer-Ufer 1 - 368167 MannheimGermany
- Telephone:
- 0621 3830
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Chirurgische Klinik Universitätsklinik MannheimTheodor-Kutzer-Ufer 1 - 368167 MannheimGermany
- Telephone:
- 0621 3830
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.umm.de
Ethics Committee
Address Ethics Committee
- Address:
- Medizinische Ethik-Kommission II Medizinischen Fakultät Mannheim, Forschungsgebäude, Haus 42 - Ebene 3Theodor-Kutzer-Ufer 1-368167 MannheimGermany
- Telephone:
- +49-621-38371770
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2022-05-09
- Ethics committee number:
- 2022-562
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2022-05-12
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry