Inguinal HerniaLFENCT01722253
Postoperative Analgesia After Low Frequency Electroacupuncture
An observational study of Inguinal Hernia, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial summary
The purpose of this study is to determine whether electroacupuncture is a effective tool to the postoperative analgesia Read more about this study
- Who is it for?
- Ages 18 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- Electroacupuncture
- Type of treatment
- Surgery or procedure
- How many people
- 54 participants
- Where
- 1 siteGreece
- Study dates
- Dec 2008to Apr 2015
- 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 75 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients in the Surgical Clinic with right or left inguinal hernia, residents of Thessaly, Greece.
Who may be able to join
- healthy male volunteers
- 18-75 years old
Who cannot join
- bilateral or recurrent hernia
- significant cardiovascular, pulmonary, renal, hepatic, neurological disease
- psychiatric history
- use of opioids until the last month
- body mass index greater than 30
- treatment with beta-blockers
Show all 11Show fewer
- aged over 75
- previous experience with acupuncture
- hypersensitivity to opioids
- pacemaker patient
- patients being treated with monoamine oxidase inhibitors and selective serotonin reuptake inhibitors.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postoperative Analgesia After Low Frequency Electroacupuncture as Adjunctive Therapy in Inguinal Hernia Surgery With Abdominal Wall Mesh Reconstruction
The purpose of this study is to determine whether electroacupuncture is a effective tool to the postoperative analgesia
Read the detailed description
The electroacupuncture is a known therapeutic modality with particular application to pain. In this study the investigators investigate the effect of electroacupuncture in condition of surgery, which is a particularly painful situation. The investigators will verify the postoperative analgesia, as patients will receive either electroacupuncture or placebo electroacupuncture.
- Conditions
- Inguinal Hernia
- Being tested
- Electroacupuncture
- Keywords
- electroacupuncture, acupuncture, pain management
- Medical subject headings
- Hernia, Inguinal, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectroacupunctureProcedure or surgery
Electrical stimulation device with frequency 2 Hz and 'frequency scanning mode'
| Study group | Role | What they receive |
|---|---|---|
| placebo, electroacupuncture | Electroacupuncture before and after surgery (40min and 60 min respectively) with frequency 2 Hz, and 'frequency scanning mode'.
Placebo electroacupuncture, in which the needles are secured (without penetrating the skin) and connected to the electrical device, which is not functional. Receives: Procedure: Electroacupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monitoring of pain with the Visual Analogue scale within the first 24 hours after surgery
Monitoring of pain with the Visual Analogue scale performed preoperatively and at 30, 90 min, 10 hours and 24 hours after surgery
Measured: within the first 24 hours after surgery
Secondary outcomes (1)
Control of anxiety with the State-Trait Anxiety Inventory within 24 hours after surgery
The State-Trait Anxiety Inventory performed preoperatively and at 30, 90 min, 10 hours and 24 hours after surgery
Measured: within the first 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2012 (estimated)
- Study startDec 2008
- Primary completionMar 2015
- Study completionApr 2015
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 Inguinal HerniaStudies 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-control
- Time perspective
- Retrospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria I. Dalamagka, Aristotle University Of Thessaloniki
- Investigators
- Dimitrios G Vasilakos, Professor, Study chair, Aristotle UniversityMaria I Dalamagka, consultant, Principal investigator, Aristotle University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01722253
- Sponsor's protocol ID
- 225
- Acronym
- LFE
- Status last verified
- Jun 2015
- First submitted
- 3 Nov 2012
- Last updated
- 8 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Dalamagka M, Mavrommatis C, Grosomanidis V, Karakoulas K, Vasilakos D. Postoperative analgesia after low-frequency electroacupuncture as adjunctive treatment in inguinal hernia surgery with abdominal wall mesh reconstruction. Acupunct Med. 2015 Oct;33(5):360-7. doi: 10.1136/acupmed-2014-010689. Epub 2015 Jun 3.
PubMed 26040491
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Analgesia After Low Frequency Electroacupuncture as Adjunctive Therapy in Inguinal Hernia Surgery With Abdominal Wall Mesh Reconstruction
- ClinicalTrials.gov ID
- NCT01722253
- Acronym / sponsor ID
- LFE / 225
- Conditions
- Inguinal Hernia
- Keywords
- electroacupuncture, acupuncture, pain management
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Mar 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 6 Nov 2012 (estimated)
- 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 purpose of this study is to determine whether electroacupuncture is a effective tool to the postoperative analgesia
Detailed description
The electroacupuncture is a known therapeutic modality with particular application to pain. In this study the investigators investigate the effect of electroacupuncture in condition of surgery, which is a particularly painful situation. The investigators will verify the postoperative analgesia, as patients will receive either electroacupuncture or placebo electroacupuncture.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| placebo, electroacupuncture | – | Procedure: ElectroacupunctureElectroacupuncture before and after surgery (40min and 60 min respectively) with frequency 2 Hz, and 'frequency scanning mode'. Placebo electroacupuncture, in which the needles are secured (without penetrating the skin) and connected to the electrical device, which is not functional. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in the Surgical Clinic with right or left inguinal hernia, residents of Thessaly, Greece.
Key inclusion criteria (2 listed)
- healthy male volunteers
- 18-75 years old
Key exclusion criteria (11 listed)
- bilateral or recurrent hernia
- significant cardiovascular, pulmonary, renal, hepatic, neurological disease
- psychiatric history
- use of opioids until the last month
- body mass index greater than 30
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 |
|---|---|---|
| ElectroacupunctureElectrical stimulation device with frequency 2 Hz and 'frequency scanning mode' | Procedure or surgery | placebo, electroacupuncture |
Primary outcome
Monitoring of pain with the Visual Analogue scale within the first 24 hours after surgery
Time frame: within the first 24 hours after surgery
Monitoring of pain with the Visual Analogue scale performed preoperatively and at 30, 90 min, 10 hours and 24 hours after surgery
1 secondary outcome
Control of anxiety with the State-Trait Anxiety Inventory within 24 hours after surgery
Time frame: within the first 24 hours after surgery
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 8 Jun 2015.
- Derived from this study: PubMed 26040491Dalamagka M, Mavrommatis C, Grosomanidis V, Karakoulas K, Vasilakos D. Postoperative analgesia after low-frequency electroacupuncture as adjunctive treatment in inguinal hernia surgery with abdominal wall mesh reconstruction. Acupunct Med. 2015 Oct;33(5):360-7. doi: 10.1136/acupmed-2014-010689. Epub 2015 Jun 3.
Related trials for Inguinal Hernia
Active, not recruiting
Evaluating the Efficacy and Safety of a New Laparoscopic Non-mesh Hernia Needle Set Designed for Indirect Inguinal Hernia
Inguinal Hernia, Without Mention of Obstruction or Gangrene
Recruiting
Desarda Tissue Technique vs Lichtenstein Technique for Primary Inguinal Hernia Repair
Inguinal Hernia Unilateral, Complications of Surgical Procedures or Medical Care
Recruiting
Permanent Versus Slowly Dissolving Stitches for Non-Mesh (Shouldice) Groin Hernia Repair
Inguinal Hernia
Active, not recruiting
Urinary Catheterization Versus No Catheterization in Laparoscopic Total Extraperitoneal Inguinal Hernia Repair
Inguinal Hernias
Recruiting
Comparison of Two Surgical Techniques for Indirect Inguinal Hernia Repair
Indirect Inguinal Hernia
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.
Dimitrios G Vasilakos, Professor study chair
Aristotle University
Maria I Dalamagka, consultant principal investigator
Aristotle University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inguinal Hernia, run by Aristotle University Of Thessaloniki at 1 site in Greece.
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 11 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 8 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. 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?
Monitoring of pain with the Visual Analogue scale within the first 24 hours after surgery (time frame: within the first 24 hours after surgery). 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 NCT01722253, 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 8 Jun 2015; AzTrials last refreshed its copy on 29 Oct 2026.