At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years
- ✓Undergoing one of specified primary surgical procedures (breast, cholecystectomy, gastrectomy, nephrolithotomy, hernia repair, arthroplasty, foot/ankle, shoulder, hand/forearm/elbow, or spinal surgery)
- ✕Implanted pulse generator (e.g., cardiac pacemaker)
- ✕Pregnancy
- ✕Incarceration
- ✕Chronic opioid or tramadol use (daily use within 2 weeks prior to surgery with duration >4 weeks)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Pulsed Electromagnetic Fields for Postoperative Analgesia: A Randomized, Triple-Masked, Sham-Controlled Pilot Study
In Brief
A clinical study evaluating Active Pulsed Shortwave Treatment with BioElectronics Model 088 and Sham Treatment for Postoperative Pain, Acute. Completed, enrolled 119 participants across 1 site.
Detailed Summary
Pulsed electromagnetic field therapy is a possible method of pain control involving the application of electromagnetic energy (also termed nonthermal, pulsed, shortwave radiofrequency therapy). 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 30 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 pilot 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 in preparation for developing subsequent definitive clinical trials.
Study Details
Timeline
Interventions
Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
Application of 7-30 days of a nonfunctional sham device(s)