Back to resultsMillimeter Wave Therapy (MWT) for Analgesia After Total Knee Replacement
Primary Purpose
Pain, Acute Pain
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Generator of electromagnetic millimeter waves
Sponsored by
About this trial
This is an interventional treatment trial for Pain focused on measuring Postoperative pain, analgesia, total knee arthroplasty
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 systemic infection history of psychiatric disease necessity to change postoperative analgesic scheme for particular patient severe intercurrent disease during the course of MWT
Sites / Locations
- Anesthesiology and Intensive Care Medicine Department, University of Greifswald, Germany
Outcomes
Primary Outcome Measures
Total amount of weak opioid drug piritramide delivered via Patient-Controlled-Analgesia pump, registered daily until the 3rd postoperative day
Secondary Outcome Measures
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
Full Information
NCT ID
NCT00233831
First Posted
October 4, 2005
Last Updated
February 25, 2011
Sponsor
University Medicine Greifswald
1. Study Identification
Unique Protocol Identification Number
NCT00233831
Brief Title
Millimeter Wave Therapy (MWT) for Analgesia After Total Knee Replacement
Official Title
Millimeter Wave Therapy (MWT) Versus Placebo for Analgesia and Wound Healing After Elective Total Knee Arthroplasty - a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
October 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Medicine Greifswald
4. Oversight
5. Study Description
Brief 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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Acute Pain
Keywords
Postoperative pain, analgesia, total knee arthroplasty
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
80 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Generator of electromagnetic millimeter waves
Primary Outcome Measure Information:
Title
Total amount of weak opioid drug piritramide delivered via Patient-Controlled-Analgesia pump, registered daily until the 3rd postoperative day
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
systemic infection
history of psychiatric disease
necessity to change postoperative analgesic scheme for particular patient
severe intercurrent disease during the course of MWT
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hardy Edinger, Resident in Anesth
Organizational Affiliation
Anesthesiology and Intensive Care Medicine Department, Ernst Moritz Arndt University of Greifswald, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anesthesiology and Intensive Care Medicine Department, University of Greifswald, Germany
City
Greifswald
ZIP/Postal Code
17487
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
18042413
Citation
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.
Results Reference
result
Learn more about this trial
Millimeter Wave Therapy (MWT) for Analgesia After Total Knee Replacement
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