At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Pulsed Electromagnetic Fields for Post-Amputation Pain: A Randomized, Triple-Masked, Sham-Controlled, Crossover Pilot Study
In Brief
A clinical study evaluating Active then Sham Treatment and Sham then Active Treatment for Phantom Limb Pain and Residual Limb Pain. Completed, enrolled 14 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 chronic post-amputation 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 30 days of nonthermal, pulsed shortwave (radiofrequency) therapy; then sham treatment after a 7-day "washout" period
Application of 30 days of sham treatment; then 30 days of nonthermal, pulsed shortwave (radiofrequency) therapy after a 7-day "washout" period