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
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)
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | Anesthesiology and Intensive Care Medicine Department, University of Greifswald, Germany | Greifswald |
Lead Sponsor | Collaborator |
---|---|
University Medicine Greifswald |
Germany,
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
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 |
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