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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00233831
• Other study ID #: III UV 11/03
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: October 4, 2005
• Last updated: February 25, 2011
• Start date: March 2004
• Est. completion date: October 2007

Study information

• Verified date: February 2011
• Source: University Medicine Greifswald
• Contact: n/a
• Is FDA regulated: No
• Health authority: European Union: European Medicines Agency
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 2007
• Est. primary completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Pain
• Pain

Intervention

Device:
• Generator of electromagnetic millimeter waves

Locations

Country	Name	City	State
Germany	Anesthesiology and Intensive Care Medicine Department, University of Greifswald, Germany	Greifswald

Sponsors (1)

Lead Sponsor	Collaborator
University Medicine Greifswald

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Usichenko TI, Edinger H, Witstruck T, Pavlovic D, Zach M, Lange J, Gizhko V, Wendt M, Koch B, Lehmann C. Millimetre wave therapy for pain relief after total knee arthroplasty: a randomised controlled trial. Eur J Pain. 2008 Jul;12(5):617-23. Epub 2007 Nov — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total amount of weak opioid drug piritramide delivered via Patient-Controlled-Analgesia pump, registered daily until the 3rd postoperative day
Secondary	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