Pulsed Electromagnetic Fields for Postoperative Analgesia: A Randomized, Triple-Masked, Sham-Controlled Pilot Study

NCT05399355 | Completed Results FDA Device

• 1 other identifier: PEMF Surgical Pilot
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Pain, Acute

Outcome Measures

Primary Outcomes (3)

• AVERAGE Pain Measured With the Numeric Rating Scale

  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

  Mean value of the average daily pain measured on postoperative days 1, 2, 3, and 7

• WORST Pain Measured With the Numeric Rating Scale

  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 worst pain scores measured with the Numeric Rating Scale

  Mean value of the worst daily pain measured on postoperative days 1, 2, 3, and 7

• Total OPIOID Consumption From Recovery Room Discharge Until the Data Collection Phone Call on Postoperative Day 7 (Measured in Oral Oxycodone Equivalents)

  Total opioid consumption from recovery room discharge until the data collection phone call on postoperative day 7 (measured in oral oxycodone equivalents).

  Cumulative opioid consumption queried on postoperative days 1, 2, 3, and 7

Secondary Outcomes (57)

• AVERAGE Pain Measured With the Numeric Rating Scale

  postoperative day 1

• AVERAGE Pain Measured With the Numeric Rating Scale

  postoperative day 2

• AVERAGE Pain Measured With the Numeric Rating Scale

  postoperative day 3

• AVERAGE Pain Measured With the Numeric Rating Scale

  postoperative day 7

• AVERAGE Pain Measured With the Numeric Rating Scale

  postoperative day 14

Study Arms (2)

Active Pulsed Shortwave Treatment with BioElectronics Model 088

ACTIVE COMPARATOR

Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088

Device: Active Pulsed Shortwave Treatment with BioElectronics Model 088

Sham Treatment

SHAM COMPARATOR

Application of 7-30 days of a nonfunctional sham device.

Device: Sham Treatment

Interventions

Active Pulsed Shortwave Treatment with BioElectronics Model 088 DEVICE

Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088

Also known as: nonthermal, pulsed shortwave (radiofrequency) therapy, pulsed electromagnetic fields therapy

Active Pulsed Shortwave Treatment with BioElectronics Model 088

Sham Treatment DEVICE

Application of 7-30 days of a nonfunctional sham device(s)

Also known as: Placebo treatment

Sham Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients of at least 18 years of age undergoing one of these primary surgical procedures:
• non-mastectomy breast surgery with a single-injection paravertebral nerve block
• laparoscopic cholecystectomy
• laparoscopic sleeve gastrectomy
• percutaneous nephrolithotomy
• ventral hernia repair
• inguinal hernia repair
• knee or hip arthroplasty
• foot/ankle surgery with at least moderate pain anticipated
• shoulder acromioclavicular joint repair, labral repair, subacromial decompression, or Bankart repair (without rotator cuff repair)
• hand/forearm/elbow surgery with at least moderate pain anticipated
• spinal surgery with at least moderate pain anticipated

You may not qualify if:

• concurrent use of an implanted pulse generator (e.g., cardiac pacemaker)
• pregnancy
• incarceration
• chronic opioid/tramadol use (daily use within the 2 weeks prior to surgery and duration of use \> 4 weeks)
• neuro-muscular deficit of the surgical area/limb
• a planned postoperative perineural local anesthetic infusion

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California, San Diego

San Diego, California, 92103, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Results Point of Contact

• Title: Brian Ilfeld, MD, MS
• Organization: University of California San Diego

baabdullah@health.ucsd.edu

(858) 220-5714

Study Officials

• Brian M Ilfeld, MD, MS

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The Investigational Drug Service will create the randomization tables and provide the investigators with the appropriate device (active or sham), leaving all participants, investigators, and the statistician masked to treatment group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Anesthesiology, In Residence

Model Details: Parallel Assignment: Randomized, Triple-Masked, Placebo-Controlled, Parallel-Arm Human Subjects Clinical Trial

Study Record Dates

• First Submitted: May 19, 2022
• First Posted: June 1, 2022
• Study Start: July 18, 2022
• Primary Completion: October 10, 2023
• Study Completion: April 3, 2024
• Last Updated: July 31, 2024
• Results First Posted: July 31, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Following publication of the final dataset.
• Access Criteria: contact the Principal Investigator, Dr. Brian Ilfeld

Locations

US (1)