Text Size

Millimeter Wave Therapy (MWT) for Analgesia After Total Knee Replacement

This study has been completed.
Sponsor:
Information provided by:
University Medicine Greifswald
ClinicalTrials.gov Identifier:
NCT00233831
First received: October 4, 2005
Last updated: February 25, 2011
Last verified: February 2011
History of Changes

October 4, 2005
February 25, 2011
March 2004
October 2006   (final data collection date for primary outcome measure)
Total amount of weak opioid drug piritramide delivered via Patient-Controlled-Analgesia pump, registered daily until the 3rd postoperative day
Same as current
Complete list of historical versions of study NCT00233831 on ClinicalTrials.gov Archive Site
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
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
Not Provided
Not Provided
 
Millimeter Wave Therapy (MWT) for Analgesia After Total Knee Replacement
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)
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Pain
  • Acute Pain
Device: Generator of electromagnetic millimeter waves
Not Provided
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. Epub 2007 Nov 26.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
October 2007
October 2006   (final data collection date for primary outcome measure)

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
Both
35 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00233831
III UV 11/03
Not Provided
Not Provided
University Medicine Greifswald
Not Provided
Principal Investigator: Hardy Edinger, Resident in Anesth Anesthesiology and Intensive Care Medicine Department, Ernst Moritz Arndt University of Greifswald, Germany
University Medicine Greifswald
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP