Chirurgical InterventionAURDO1NCT06693167
Adjuvant Treatment of Postoperative Pain Following Endoscopic Carpal Tunnel Surgery by Auriculotherapy
An observational study of Chirurgical Intervention and Auriculotherapy, run by Clinique Bizet.
Trial summary
Retrospective study on the effect of auriculotherapy on postoperative pain after carpal tunnel surgery Read more about this study
- Who is it for?
- Ages 18 to 84 years
- Conditions the study is for
- Chirurgical Intervention, Auriculotherapy
- What is being tested?
- chirurgie canal carpien
- Type of treatment
- Surgery or procedure
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to Jun 2017
- How long will I take part?
- 7 Days
- 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 to 84 years
- All sexes
- Adult, Older adult
Study population: Patients suffering from carpal tunnel syndrome for whom elective endoscopic surgery is indicated
Who may be able to join
- Patients aged 18 to 84 years.
- Patients suffering from carpal tunnel syndrome for whom elective endoscopic surgery is indicated
Who cannot join
- Have already benefited from an auriculotherapy session.
- Presence of cryoglobulinemia.
- Presence of Raynaud's syndrome.
- Presence of hemoglobinopathy (hemoglobin and capillary abnormalities).
- Allergy to cold.
- Presence of dermatological lesions on the auricle of one of the two ears
About this study
Retrospective study on the effect of auriculotherapy on postoperative pain after carpal tunnel surgery
Read the detailed description
the project consists of a retrospective analysis of data from the medical records of patients followed by Doctor, between 2016 and 2017, at the Bizet Clinic. This study includes measurements of pain levels and analgesic consumption in patients who received during their care in the clinic a preoperative auriculotherapy session offered by the clinic, during the three days following carpal tunnel surgery. For comparison, this studie also includes a group who underwent the same surgery treated only with analgesics. The objective of study is to analyze the results obtained in the two groups in order to evaluate the effectiveness of auriculotherapy for the management of postoperative pain.
- Conditions
- Chirurgical Intervention, Auriculotherapy
- Being tested
- chirurgie canal carpien
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chirurgie canal carpienProcedure or surgery
study compares a group of patients who received a preoperative auriculotherapy session followed by standard analgesic treatment to a group who received only standard analgesic treatment, and this, during the three days following surgery (D1, D2, and D3).
What is being measured
The primary outcome is the main question the study is designed to answer.
demonstrate the effectiveness of auriculotherapy in the management of postoperative pain
pain assessment scale
Measured: Day1, Day2 and Day 3
Secondary outcomes (1)
reducing the consumption of painkillers
number of tablets in grams
Measured: Day1, Day2 and Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2024
- Study startOct 2016
- Primary completionMay 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chirurgical InterventionStudies 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
- Case only
- Time perspective
- Other
- Enrolment
- 38 participants (actual)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Clinique Bizet
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06693167
- Sponsor's protocol ID
- 0990-0279
- Acronym
- AURDO1
- Status last verified
- Oct 2024
- First submitted
- 12 Nov 2024
- Last updated
- 18 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Treatment of Postoperative Pain Following Endoscopic Carpal Tunnel Surgery by Auriculotherapy
- ClinicalTrials.gov ID
- NCT06693167
- Acronym / sponsor ID
- AURDO1 / 0990-0279
- Conditions
- Chirurgical Intervention, Auriculotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Clinique BizetUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 18 Nov 2024 (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.
Retrospective study on the effect of auriculotherapy on postoperative pain after carpal tunnel surgery
Detailed description
the project consists of a retrospective analysis of data from the medical records of patients followed by Doctor, between 2016 and 2017, at the Bizet Clinic. This study includes measurements of pain levels and analgesic consumption in patients who received during their care in the clinic a preoperative auriculotherapy session offered by the clinic, during the three days following carpal tunnel surgery. For comparison, this studie also includes a group who underwent the same surgery treated only with analgesics. The objective of study is to analyze the results obtained in the two groups in order to evaluate the effectiveness of auriculotherapy for the management of postoperative pain.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 7 Days
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients suffering from carpal tunnel syndrome for whom elective endoscopic surgery is indicated
Key inclusion criteria (2 listed)
- Patients aged 18 to 84 years.
- Patients suffering from carpal tunnel syndrome for whom elective endoscopic surgery is indicated
Key exclusion criteria (6 listed)
- Have already benefited from an auriculotherapy session.
- Presence of cryoglobulinemia.
- Presence of Raynaud's syndrome.
- Presence of hemoglobinopathy (hemoglobin and capillary abnormalities).
- Allergy to cold.
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 |
|---|---|---|
| chirurgie canal carpienstudy compares a group of patients who received a preoperative auriculotherapy session followed by standard analgesic treatment to a group who received only standard analgesic treatment, and this, during the three days following surgery (D1, D2, and D3). | Procedure or surgery | – |
Primary outcome
demonstrate the effectiveness of auriculotherapy in the management of postoperative pain
Time frame: Day1, Day2 and Day 3
pain assessment scale
1 secondary outcome
reducing the consumption of painkillers
Time frame: Day1, Day2 and Day 3
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 18 Nov 2024.
- 6- Sator-Katzenschlager, S. M., Scharbert, G., Kozek-Langenecker, S. A., Dolezal, S., Michalek-Sauberer, A., Kress, H. G., \& Heinze, G. (2003). The short- and long-term benefit in chronic low back pain through adjuvant electrical versus manual auricularLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Chirurgical Intervention and Auriculotherapy, run by Clinique Bizet.
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 2 inclusion and 6 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 18 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
demonstrate the effectiveness of auriculotherapy in the management of postoperative pain (time frame: Day1, Day2 and Day 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Nov 2024.