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Completed

NCT Number: NCT00233831

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

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)

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Key information

Conditions

Pain Acute Pain Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Complications Signs and Symptoms

Age range

35 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Anesthesiology and Intensive Care Medicine Department, University of Greifswald, Germany

Greifswald, 17487, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Generator of electromagnetic millimeter waves

Device

Primary outcomes

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

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Medicine Greifswald

Other

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2006
Study completion
2007
First posted
Oct 6, 2005
Registry last updated
Feb 28, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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