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Pulsed Electromagnetic Fields for Post-Amputation Pain

NCT05392803 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2024-09-19

Study results available
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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.

Conditions

  • Phantom Limb Pain
  • Residual Limb Pain

Interventions

DEVICE

Active then Sham Treatment

Application of 30 days of nonthermal, pulsed shortwave (radiofrequency) therapy; then sham treatment after a 7-day "washout" period

DEVICE

Sham then Active Treatment

Application of 30 days of sham treatment; then 30 days of nonthermal, pulsed shortwave (radiofrequency) therapy after a 7-day "washout" period

Sponsors & Collaborators

Principal Investigators

  • Brian Ilfeld, MD, MS · University of California, San Diego

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-05
Primary Completion
2023-08-10
Completion
2023-08-17
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05392803 on ClinicalTrials.gov