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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
  Purpose

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 Intervention Phase
Pain
Acute Pain
 Device: Generator of electromagnetic millimeter waves
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

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

Further study details as provided by University Medicine Greifswald:

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

Estimated Enrollment: 80
Study Start Date: March 2004
Study Completion Date: October 2007
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   35 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00233831     History of Changes
Other Study ID Numbers: III UV 11/03
Study First Received: October 4, 2005
Last Updated: February 25, 2011
Health Authority: European Union: European Medicines Agency

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

ClinicalTrials.gov processed this record on June 17, 2013