PainPhase 2/3NCT00233831
Millimeter Wave Therapy (MWT) for Analgesia After Total Knee Replacement
A Phase 2/3 study testing Generator of electromagnetic millimeter waves in people with Pain and Acute Pain, run by University Medicine Greifswald at 1 site in Germany.
Trial summary
The aim of the study was to test whether the exposure to electromagnetic millimeter waves - Millimeter Wave Therapy (MWT) is effective for relief of acute postoperative pain in patients after elective unilateral total knee arthroplasty (TKA) Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Pain, Acute Pain
- What is being tested?
- Generator of electromagnetic millimeter waves
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2004to Oct 2007
- 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 35 to 80 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 II or III scheduled for elective TKA
- without previous opioid medication
- patients 35-80 years old able to use PCA pumps and Visual Analogue Scale for pain intensity measurement
- patients who have signed consent form
Who cannot join
- pregnant or nursing females
- recidivist alcoholics
- extremely obese patients (body mass index > 35)
- inability to operate PCA-pump.
- females with the history of unstable angina pectoris (s. Risks for participants)
- patients who are unable to understand the consent form
Show all 10Show fewer
- systemic infection
- history of psychiatric disease
- necessity to change postoperative analgesic scheme for particular patient
- severe intercurrent disease during the course of MWT
Trial locations and contacts
1 site in 1 country.
Germany1 site
Anesthesiology and Intensive Care Medicine Department, University of Greifswald, Germany
Greifswald, 17487
About this study
Official title: Millimeter Wave Therapy (MWT) Versus Placebo for Analgesia and Wound Healing After Elective Total Knee Arthroplasty - a Randomized Controlled Trial
The aim of the study was to test whether the exposure to electromagnetic millimeter waves - Millimeter Wave Therapy (MWT) is effective for relief of acute postoperative pain in patients after elective unilateral total knee arthroplasty (TKA)
- Conditions
- Pain, Acute Pain
- Being tested
- Generator of electromagnetic millimeter waves
- Keywords
- Postoperative pain, analgesia, total knee arthroplasty
- Medical subject headings
- Pain, Acute Pain, Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Generator of electromagnetic millimeter wavesDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Total amount of weak opioid drug piritramide delivered via Patient-Controlled-Analgesia pump, registered daily until the 3rd postoperative day
Secondary outcomes (1)
Total amount of ibuprofen; pain intensity measured on VAS-100 twice a day; Insall knee function score; incidence of analgesia side-effects ; inflammation and wound healing parameters; credibility of patients' and research stuff blinding
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2005 (estimated)
- Study startMar 2004
- Primary completionOct 2006
- Study completionOct 2007
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 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
- 80 participants
Sponsor and investigators
- Lead sponsor
- University Medicine Greifswald
- Sponsor type
- University, hospital or other
- Investigators
- Hardy Edinger, Resident in Anesth, Principal investigator, Anesthesiology and Intensive Care Medicine Department, Ernst Moritz Arndt University of Greifswald, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00233831
- Sponsor's protocol ID
- III UV 11/03
- Status last verified
- Feb 2011
- First submitted
- 4 Oct 2005
- Last updated
- 28 Feb 2011
- Results posted
- No
Publications
Usichenko TI, Edinger H, Witstruck T, Pavlovic D, Zach M, Lange J, Gizhko V, Wendt M, Koch B, Lehmann C. Millimetre wave therapy for pain relief after total knee arthroplasty: a randomised controlled trial. Eur J Pain. 2008 Jul;12(5):617-23. doi: 10.1016/j.ejpain.2007.10.004. Epub 2007 Nov 26.
PubMed 18042413
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
- Millimeter Wave Therapy (MWT) Versus Placebo for Analgesia and Wound Healing After Elective Total Knee Arthroplasty - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00233831
- Acronym / sponsor ID
- III UV 11/03
- Conditions
- Pain, Acute Pain
- Keywords
- Postoperative pain, analgesia, total knee arthroplasty
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants
- Lead sponsor
- University Medicine GreifswaldUniversity, hospital or other
- Study start
- Mar 2004
- Primary completion
- Oct 2006 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 6 Oct 2005 (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 of the study was to test whether the exposure to electromagnetic millimeter waves - Millimeter Wave Therapy (MWT) is effective for relief of acute postoperative pain in patients after elective unilateral total knee arthroplasty (TKA)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients with an American Society of Anesthesiologists physical status of II or III scheduled for elective TKA
- without previous opioid medication
- patients 35-80 years old able to use PCA pumps and Visual Analogue Scale for pain intensity measurement
- patients who have signed consent form
Key exclusion criteria (10 listed)
- pregnant or nursing females
- recidivist alcoholics
- extremely obese patients (body mass index > 35)
- inability to operate PCA-pump.
- females with the history of unstable angina pectoris (s. Risks for participants)
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 |
|---|---|---|
| Generator of electromagnetic millimeter waves | Device | – |
Primary outcome
Total amount of weak opioid drug piritramide delivered via Patient-Controlled-Analgesia pump, registered daily until the 3rd postoperative day
1 secondary outcome
Total amount of ibuprofen; pain intensity measured on VAS-100 twice a day; Insall knee function score; incidence of analgesia side-effects ; inflammation and wound healing parameters; credibility of patients' and research stuff blinding
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.
- Results publication: PubMed 18042413Usichenko TI, Edinger H, Witstruck T, Pavlovic D, Zach M, Lange J, Gizhko V, Wendt M, Koch B, Lehmann C. Millimetre wave therapy for pain relief after total knee arthroplasty: a randomised controlled trial. Eur J Pain. 2008 Jul;12(5):617-23. doi: 10.1016/j.ejpain.2007.10.004. Epub 2007 Nov 26.
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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.
Hardy Edinger, Resident in Anesth principal investigator
Anesthesiology and Intensive Care Medicine Department, Ernst Moritz Arndt University of Greifswald, Germany
1 site 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 Generator of electromagnetic millimeter waves in people with Pain and Acute Pain, run by University Medicine Greifswald at 1 site 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 4 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 1 site 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?
Total amount of weak opioid drug piritramide delivered via Patient-Controlled-Analgesia pump, registered daily until the 3rd postoperative day. 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 NCT00233831, 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 28 Feb 2011; AzTrials last refreshed its copy on 6 Nov 2026.