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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

ClinicalTrials.gov processed this record on September 22, 2014