To statistically evaluate published clinical efficacy data related to the use of pulsed radio frequency energy (PRFE) therapy in 3 clinical applications.
Numerous clinical studies have reported efficacy outcomes for PRFE therapy use in the palliative treatment of both postoperative and nonpostoperative pain and edema, and for its use as an adjunctive wound-healing (WH) therapeutic. Although diverse in design and endpoint, these studies are amenable to systematic review using both a vote-counting and P-value combination meta-analytic technique.
A meta-analysis of efficacy outcomes reported in clinical trials was performed using a vote-counting procedure. In addition, when possible, the sum of logs method of P-value combination was used to determine a significance level for the combined evidence within each endpoint and clinical area.
Of the 186 clinical articles identified after application of selection criteria, there were 25 controlled trials that met criteria for inclusion in vote-counting and P-value combination methods and were used for formal statistical analysis. In total, 1332 patients receiving PRFE treatment were studied. Vote-counting procedure applied to clinical outcomes from controlled studies resulted in a greater number of positive outcomes than neutral outcomes, and zero negative outcomes, for each of the clinical application groups evaluated. The sum of logs P-value method found statistically significant improvement in pain, reduction in edema, and improvement in WH outcomes.
On the basis of statistical evaluation of published clinical efficacy data, there is strong statistical evidence that PRFE therapy is effective in the treatment of postoperative and nonpostoperative pain and edema and in WH applications.
A meta-analysis was conducted to evaluate the efficacy of pulsed radio-frequency energy treatment in 3 reported uses. By applying the vote-counting procedure and the sum of logs P-value combination method, strong statistical evidence is provided that demonstrates the efficacy of pulsed radio-frequency energy treatment in the 3 applications examined.
*Department of Plastic Surgery, Lahey Clinic Medical Center, Burlington, MA
†Regenesis Biomedical, Inc, Scottsdale, AZ
‡Technomics Research, LLC, Minneapolis, MN. Dr. Kubat is an independent contract consultant.
Reprints: Lifei Guo, MD, PhD, FACS, Department of Plastic Surgery, Lahey Clinic Medical Center, 41 Mall Road, Burlington, MA 01805. E-mail: email@example.com
Received for publication October 27, 2010; revision April 28, 2011; accepted November 30, 2011.
Disclosure: No support was received for this research article.