Pulsed Shortwave Therapy for Postoperative Analgesia

NCT05796583 | Completed Results FDA Device

• 1 other identifier: PSWT SofPulse
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Pulsed shortwave (radiofrequency) therapy is a possible method of pain control involving the application of electromagnetic energy (also termed pulsed electromagnetic fields). 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 8 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 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.

Conditions

Postoperative Pain, Acute

Outcome Measures

Primary Outcomes (1)

• 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 primary outcome calculated as follows: for each participant all of the "average" and "worst" daily pain scores collected within the first 7 postoperative days will be summed: specifically on Days 1, 2, 3, and 7, resulting in a scale of 0-80.

  First postoperative week

Secondary Outcomes (40)

• 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 SofPulse

ACTIVE COMPARATOR

Application of 8 days of nonthermal, pulsed shortwave (radiofrequency) therapy with Endonovo Therapeutics SofPulse

Device: Active Pulsed Shortwave Treatment

Sham Treatment

SHAM COMPARATOR

Application of 8 days of sham device

Device: Sham Treatment

Interventions

Active Pulsed Shortwave Treatment DEVICE

Application of 8 days of nonthermal, pulsed shortwave (radiofrequency) therapy with Endonovo Therapeutics SofPulse

Also known as: non thermal, pulsed shortwave (radio frequency) therapy, pulsed electromagnetic fields therapy

Active Pulsed Shortwave Treatment with SofPulse

Sham Treatment DEVICE

Application of 8 days of a nonfunctional sham device

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 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

Related Publications (1)

• Ilfeld BM, Finneran JJ 4th, Said ET, Ball ST, Sandler BJ, Broderick RC, Gonzales FB, Lau NJ, Schaar A, Abdullah B. Pulsed Shortwave (Radiofrequency) Therapy With a Noninvasive, Wearable, Disposable Device: A Randomized, Participant- and Assessor-Masked, Sham-Controlled Pilot Study. Neuromodulation. 2025 Jun;28(4):682-689. doi: 10.1016/j.neurom.2025.01.008. Epub 2025 Feb 20.

  PMID: 39985539 DERIVED

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: Professor of Anesthesiology
• Organization: University of California San Diego

bilfeld@health.ucsd.edu

(858) 220-5714

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, 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 with the exception of the study coordinator who receives the study device from the Investigational Drug Service.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology, In Residence

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

Study Record Dates

• First Submitted: March 20, 2023
• First Posted: April 3, 2023
• Study Start: April 4, 2023
• Primary Completion: May 2, 2024
• Study Completion: October 20, 2024
• Last Updated: March 17, 2025
• Results First Posted: March 17, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)