At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Pulsed Electromagnetic Fields for Postoperative and Post-Amputation Analgesia: A Randomized, Participant- and Observer-Masked, Sham-Controlled Pilot Study
In Brief
A clinical study evaluating Active Pulsed Shortwave Treatment and Sham Treatment for Postoperative Pain, Acute. Completed, enrolled 70 participants across 1 site.
Detailed Summary
Pulsed shortwave (radiofrequency) therapy is a possible method of pain control involving the application of electromagnetic energy (also termed pulsed electromagnetic fields). Food and Drug Administration-cleared devices have been in clinical use for over 70 years. For decades, available devices consisted of a large signal generator and bulky coil applicator that were not portable and produced significant electromagnetic interference, making them impractical for common use. However, small, lightweight, relatively inexpensive, noninvasive, Food and Drug Administration-cleared devices that function for 8 days are now available to treat acute and chronic pain, decrease inflammation and edema, and hasten wound healing and bone regeneration. Therefore, it has the potential to concurrently improve analgesia and decrease or even negate opioid requirements, only without the limitations of opioids and peripheral nerve blocks. The purpose of this study is to explore the possibility of treating acute postoperative pain with nonthermal, pulsed shortwave (radiofrequency) therapy, optimize the study protocol, and estimate the treatment effect.
Study Details
Timeline
Interventions
Application of 8 days of nonthermal, pulsed shortwave (radiofrequency) therapy with Endonovo Therapeutics SofPulse
Application of 8 days of a nonfunctional sham device