Affiliation:
1. Dr Jackson and Mangione are from The Ambulatory Care Center Surgery, Marion, IN; Dr Roche is from the Roche Clinic, Bloomfield Hills, MI
Abstract
Introduction: The purpose of this Institutional Review Board (IRB)-approved, placebo-controlled, randomized, double-blinded parallel-grouped, multicenter trial was to determine the effectiveness of low-level laser therapy (LLLT) in decreasing patients' postoperative pain 24 hours post breast augmentation surgery. Materials and Methods: The Erchonia EML, 630–640 nm, (Erchonia Medicial, Inc., McKinney, Texas) with 2 7-mw laser-emitting diodes was used within 10 minutes of the start of the procedure over each breast for 4 minutes at a distance of 6 inches. This was repeated within 10 minutes of completion of the procedure with the same methodology. One hundred and four (104) patients participated in the study, 50 test subjects and 54 controls. Primary investigator and patient were blinded with respect to treatment group. Results: The success criteria for this study using the standardized Visual Analogue Scale (VAS) was a self-reported degree-of-pain rating of less than 30 at 24 hours after the implant procedure. At this time the patient had not taken pain medication for 4 hours. Overall study success criteria were defined as at least 30% difference between treatment groups with respect to proportion of successes. At the 24-hour time interval 37 (74%) of the test subjects and 20 (37%) of the control subjects met the success criteria, a difference of 37% (p<.0002). The amount of pain medication used over the first 7 days post operatively was measured as a covariant. The test subjects used less medication 848 versus 932 total doses (p<.01). Conclusion: Low-level laser therapy is effective at significantly decreasing postoperative pain and the amount of pain medication needed after breast augmentation at 1 day and 1 week respectfully. All other covariants studied including, implant type, implant size, incision size, implant location, test site location, amount of swelling measurements, hydration level, and adverse events were found to be neglible.
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14 articles.
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