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NCT05399355 · ClinicalTrials.gov registry record · NA
Pulsed Electromagnetic Fields for Postoperative Analgesia: A Randomized, Triple-Masked, Sham-Controlled Pilot Study
A NA study of Postoperative Pain, Acute, sponsored by University of California, San Diego.
- Completed
- Registry status
- NA
- Development phase
- 119
- Enrollment target
- 1
- Study location
NCT05399355: Completed NA study of Postoperative Pain, Acute, sponsored by University of California, San Diego.
NCT05399355 is a NA study of Postoperative Pain, Acute that has completed, run by University of California, San Diego. The registered enrollment target is 119 participants, below the 189-participant average among 7 other Postoperative Pain, Acute trials with a reported enrollment target (37% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05399355, a NA study of Postoperative Pain, Acute, has completed, sponsored by University of California, San Diego.
- COMPLETED
- Registry status
- NA
- Development phase
- 119 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale. The outcome will the mean value of daily average pain scores measured with the Numeric Rating Scale
Conditions Studied
Interventions
- DEVICE Active Pulsed Shortwave Treatment with BioElectronics Model 088
- DEVICE Sham Treatment
Study Locations (1)
California
- University of California, San Diego - San Diego
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 119 participants |
| Start Date | 2022-07-18 |
| Est. Completion | 2024-04-03 |
| Phase | NA |
What the finished NCT05399355 record still lists
NCT05399355 is an interventional study that assigns participants to a tested intervention. The registered 119 participants enrollment target is mid-sized for trials with a published cap, below the 189-participant average among 7 other Postoperative Pain, Acute trials with a reported enrollment target (37% lower).
The record links to 1 condition, with Postoperative Pain, Acute appearing as the primary indexed condition, and to 2 interventions - of which Active Pulsed Shortwave Treatment with BioElectronics Model 088 is the first listed.
NCT05399355 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05399355 about?
NCT05399355 is a clinical study titled "Pulsed Electromagnetic Fields for Postoperative Analgesia: A Randomized, Triple-Masked, Sham-Controlled Pilot Study". 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, ava...
What is the current status of trial NCT05399355?
This trial is currently completed. It is a NA study. The enrollment target is 119 participants. The study started on 2022-07-18. Estimated completion is 2024-04-03.
What conditions does trial NCT05399355 study?
This clinical trial studies the following conditions: Postoperative Pain, Acute.
What interventions are being tested in trial NCT05399355?
The interventions under investigation include: Active Pulsed Shortwave Treatment with BioElectronics Model 088 (DEVICE), Sham Treatment (DEVICE).
Who is sponsoring clinical trial NCT05399355?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05399355 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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