Active Pulsed Shortwave Treatment with BioElectronics Model 088 for Acute Pain

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of California, San Diego, San Diego, CA
Acute Pain+2 More
Active Pulsed Shortwave Treatment with BioElectronics Model 088 - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions

  • Acute Pain
  • Pain

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 15 Secondary · Reporting Duration: Intraoperative (within the operating room)

Day 1
Total OPIOID consumption from recovery room discharge until the data collection phone call on postoperative day 7 (measured in oral oxycodone equivalents)
Intraoperative (within the operating room)
Surgical duration
Surgical start as recorded using military time format
Surgical stop as recorded using military time format
Day 14
Passive flexion (knee and hip arthroplasty patients only)
One single measure recorded following the day of surgery
Day stopped using intervention
One single measure recorded on or following the day of surgery (whichever day patient is discharged)
Hospitalization duration measured in days
Postoperative day 28
Device location changes
postoperative day 180
AVERAGE pain measured with the Numeric Rating Scale
Opioid consumption of the previous 24 hours (measured in oral oxycodone equivalents)
WORST pain measured with the Numeric Rating Scale
postoperative day 28
Awakenings due to pain
Brief pain Inventory, short form (interference subscale)
CURRENT pain measured with the Numeric Rating Scale
LEAST pain measured with the Numeric Rating Scale
Day 28
Desire use of device in hypothetical future surgery?

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Active Pulsed Shortwave Treatment with BioElectronics Model 088
1 of 2
Sham Treatment
1 of 2
Active Control
Non-Treatment Group

200 Total Participants · 2 Treatment Groups

Primary Treatment: Active Pulsed Shortwave Treatment with BioElectronics Model 088 · Has Placebo Group · N/A

Active Pulsed Shortwave Treatment with BioElectronics Model 088
Device
ActiveComparator Group · 1 Intervention: Active Pulsed Shortwave Treatment with BioElectronics Model 088 · Intervention Types: Device
Sham Treatment
Device
ShamComparator Group · 1 Intervention: Sham Treatment · Intervention Types: Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: intraoperative (within the operating room)
Closest Location: University of California, San Diego · San Diego, CA
Photo of san diego 1Photo of san diego 2Photo of san diego 3
2022First Recorded Clinical Trial
5 TrialsResearching Acute Pain
290 CompletedClinical Trials

Who is running the clinical trial?

University of California, San DiegoLead Sponsor
1,007 Previous Clinical Trials
1,792,964 Total Patients Enrolled
9 Trials studying Acute Pain
706 Patients Enrolled for Acute Pain

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have knee or hip replacement surgery.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.