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

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ClinicalTrials.gov Identifier: NCT00233831
Recruitment Status : Completed
First Posted : October 6, 2005
Last Update Posted : February 28, 2011
Sponsor:
Information provided by:
University Medicine Greifswald

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)

Condition or disease Intervention/treatment Phase
Pain Acute Pain Device: Generator of electromagnetic millimeter waves Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Millimeter Wave Therapy (MWT) Versus Placebo for Analgesia and Wound Healing After Elective Total Knee Arthroplasty - a Randomized Controlled Trial
Study Start Date : March 2004
Actual Primary Completion Date : October 2006
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement
U.S. FDA Resources




Primary Outcome Measures :
  1. Total amount of weak opioid drug piritramide delivered via Patient-Controlled-Analgesia pump, registered daily until the 3rd postoperative day

Secondary Outcome Measures :
  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


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Ages Eligible for Study:   35 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00233831


Locations
Germany
Anesthesiology and Intensive Care Medicine Department, University of Greifswald, Germany
Greifswald, Germany, 17487
Sponsors and Collaborators
University Medicine Greifswald
Investigators
Principal Investigator: Hardy Edinger, Resident in Anesth Anesthesiology and Intensive Care Medicine Department, Ernst Moritz Arndt University of Greifswald, Germany

Publications of Results:
ClinicalTrials.gov Identifier: NCT00233831     History of Changes
Other Study ID Numbers: III UV 11/03
First Posted: October 6, 2005    Key Record Dates
Last Update Posted: February 28, 2011
Last Verified: February 2011

Keywords provided by University Medicine Greifswald:
Postoperative pain
analgesia
total knee arthroplasty

Additional relevant MeSH terms:
Acute Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms