Millimeter Wave Therapy (MWT) for Analgesia After Total Knee Replacement - Full Text View

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

This study is ongoing, but not recruiting participants.

Sponsored by:	Ernst Moritz Arndt University of Greifswald
Information provided by:	Ernst Moritz Arndt University of Greifswald
ClinicalTrials.gov Identifier:	NCT00233831

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 II

MedlinePlus related topics:

Knee Replacement

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Official Title:	Millimeter Wave Therapy (MWT) Versus Placebo for Analgesia and Wound Healing After Elective Total Knee Arthroplasty - a Randomized Controlled Trial

Further study details as provided by Ernst Moritz Arndt University of 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

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

Ernst Moritz Arndt University of Greifswald

Investigators


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

More Information

Study ID Numbers:	III UV 11/03
First Received:	October 4, 2005
Last Updated:	June 3, 2006
ClinicalTrials.gov Identifier:	NCT00233831
Health Authority:	European Union: European Medicines Agency

Keywords provided by Ernst Moritz Arndt University of Greifswald:

Postoperative pain

analgesia

total knee arthroplasty

Study placed in the following topic categories:

Pain

Pain, Postoperative

ClinicalTrials.gov processed this record on October 03, 2008