Acute PainPhase 2/3NCT00334165
Auricular Acupuncture for Analgesia During Total Hip Arthroplasty
A Phase 2/3 study testing Auricular acupuncture (procedure) in people with Acute Pain and Total Hip Arthroplasty, run by University Medicine Greifswald at 2 sites in Germany.
Trial summary
The aim is to investigate whether auricular acupuncture is superior to sham acupuncture in relief of acute pain and in reduction of analgesics in patients during total hip arthroplasty Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Acute Pain, Total Hip Arthroplasty
- What is being tested?
- Auricular acupuncture (procedure)
- Type of treatment
- Surgery or procedure
- How many people
- 360 participants
- Where
- 2 sitesGermany
- Study dates
- Jun 2005to Jun 2008
- Phase
- Phase 2/3
- 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 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with an American Society of Anesthesiologists physical status of I to III scheduled for elective hip arthroplasty because of degenerative osteoarthritis under general anesthesia.
- Surgery time does not exceed 100 minutes.
- Patients without previous opioid medication.
- Patients ranged 45-85 years old.
- Patients who have given informed consent.
Who cannot join
- Pregnant or nursing females.
- Recidivist alcoholics.
- Local or systemic infection.
- Age < 45 and > 85 years.
- Surgery time more than 100 minutes.
- Intraoperative complications (bleeding, required blood transfusion more than 4 units of packed cells , cardiovascular instability, required catecholamines).
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- Patients consumed opioid medication before surgery.
- Patients with prosthetic or damaged cardiac valves.
- Patients who are unable to understand the consent form.
- History of psychiatric disease.
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
University of Berlin, Campus Charite
Berlin, 10117
Ernst Moritz Arndt University
Greifswald, 17475
About this study
Official title: Auricular Acupuncture (AA) vs. Sham Acupuncture for Complementary Analgesia During Elective Total Hip Arthroplasty: a Randomized Controlled Trial
The aim is to investigate whether auricular acupuncture is superior to sham acupuncture in relief of acute pain and in reduction of analgesics in patients during total hip arthroplasty
- Conditions
- Acute Pain, Total Hip Arthroplasty
- Being tested
- Auricular acupuncture (procedure)
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auricular acupuncture (procedure)Procedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative analgesics requirement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2006 (estimated)
- Study startJun 2005
- Primary completionMar 2007
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medicine Greifswald
- Sponsor type
- University, hospital or other
- Collaborators
- Humboldt-Universität zu Berlin
- Investigators
- Taras I Usichenko, M.D., Study chair, Ernst Moritz Arndt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00334165
- Sponsor's protocol ID
- III UV 13/05
- Status last verified
- Feb 2011
- First submitted
- 3 Jun 2006
- Last updated
- 28 Feb 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Auricular Acupuncture (AA) vs. Sham Acupuncture for Complementary Analgesia During Elective Total Hip Arthroplasty: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00334165
- Acronym / sponsor ID
- III UV 13/05
- Conditions
- Acute Pain, Total Hip Arthroplasty
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- University Medicine GreifswaldUniversity, hospital or other
- Collaborators
- Humboldt-Universität zu Berlin
- Study start
- Jun 2005
- Primary completion
- Mar 2007 (actual)
- Study completion
- Jun 2008
- First posted
- 6 Jun 2006 (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 aim is to investigate whether auricular acupuncture is superior to sham acupuncture in relief of acute pain and in reduction of analgesics in patients during total hip arthroplasty
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with an American Society of Anesthesiologists physical status of I to III scheduled for elective hip arthroplasty because of degenerative osteoarthritis under general anesthesia.
- Surgery time does not exceed 100 minutes.
- Patients without previous opioid medication.
- Patients ranged 45-85 years old.
- Patients who have given informed consent.
Key exclusion criteria (10 listed)
- Pregnant or nursing females.
- Recidivist alcoholics.
- Local or systemic infection.
- Age < 45 and > 85 years.
- Surgery time more than 100 minutes.
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 |
|---|---|---|
| Auricular acupuncture (procedure) | Procedure or surgery | – |
Primary outcome
Intraoperative analgesics requirement
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 28 Feb 2011.
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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.
Taras I Usichenko, M.D. study chair
Ernst Moritz Arndt University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Auricular acupuncture (procedure) in people with Acute Pain and Total Hip Arthroplasty, run by University Medicine Greifswald at 2 sites in Germany.
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 10 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 28 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Intraoperative analgesics requirement. 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 28 Feb 2011.