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

NCT ID: NCT00233831

Last Updated: 2011-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2007-10-31

Brief Summary

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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)

Detailed Description

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Conditions

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Pain Acute Pain

Keywords

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Postoperative pain analgesia total knee arthroplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Generator of electromagnetic millimeter waves

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Medicine Greifswald

OTHER

Sponsor Role lead

Principal Investigators

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Hardy Edinger, Resident in Anesth

Role: PRINCIPAL_INVESTIGATOR

Anesthesiology and Intensive Care Medicine Department, Ernst Moritz Arndt University of Greifswald, Germany

Locations

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

Greifswald, , Germany

Site Status

Countries

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Germany

References

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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. doi: 10.1016/j.ejpain.2007.10.004. Epub 2007 Nov 26.

Reference Type RESULT
PMID: 18042413 (View on PubMed)

Other Identifiers

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III UV 11/03

Identifier Type: -

Identifier Source: org_study_id