Active then Sham Treatment for Residual Limb Pain

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Univerity of California San Diego, San Diego, CA
Residual Limb Pain+2 More
Active then Sham Treatment - 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 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.

Eligible Conditions

  • Residual Limb Pain
  • Pain

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

4 Primary · 15 Secondary · Reporting Duration: Days 2, 4, 7, 21, 28, and 35 for both initial and crossover treatments

Baseline and Day 28
Change in average PHANTOM limb pain scores between baseline and Day 28 of the initial treatment as measured with the Numeric Rating Scale
Change in average RESIDUAL limb pain scores between baseline and Day 28 of the initial treatment as measured with the Numeric Rating Scale
Day 28
Patient Global Impression of Change for PHANTOM limb pain between baseline and Day 28 of the initial treatment
Patient Global Impression of Change for RESIDUAL limb pain between baseline and Day 28 of the initial treatment
Day 2
Change in AVERAGE PHANTOM pain from baseline measured with the Numeric Rating Scale
Change in AVERAGE RESIDUAL pain from baseline measured with the Numeric Rating Scale
Change in WORST PHANTOM pain from baseline measured with the Numeric Rating Scale
Change in WORST RESIDUAL pain from baseline measured with the Numeric Rating Scale
Patient Global Impression of Change for PHANTOM limb pain
Patient Global Impression of Change for RESIDUAL limb pain
Day 28
Change in CURRENT PHANTOM pain from baseline measured with the Numeric Rating Scale
Change in CURRENT RESIDUAL pain from baseline measured with the Numeric Rating Scale
Change in LEAST PHANTOM pain from baseline measured with the Numeric Rating Scale
Change in LEAST RESIDUAL pain from baseline measured with the Numeric Rating Scale
Day 2
As-needed (non-scheduled) analgesic use
Day 35
Does patient want to continue using device?
Day 2
Device location changes
Day 2
Awakenings due to pain the previous evening
Day 28
Brief pain inventory, short form (interference sub scale)

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Active then Sham Treatment
1 of 2
Sham then Active Treatment
1 of 2
Experimental Treatment

40 Total Participants · 2 Treatment Groups

Primary Treatment: Active then Sham Treatment · No Placebo Group · N/A

Active then Sham Treatment
Device
Experimental Group · 1 Intervention: Active then Sham Treatment · Intervention Types: Device
Sham then Active Treatment
Device
Experimental Group · 1 Intervention: Sham then Active Treatment · Intervention Types: Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: days 2, 4, 7, 21, 28, and 35 for both initial and crossover treatments
Closest Location: Univerity of California San Diego · San Diego, CA
Photo of san diego 1Photo of san diego 2Photo of san diego 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Residual Limb Pain
0 CompletedClinical Trials

Who is running the clinical trial?

University of California, San DiegoLead Sponsor
1,007 Previous Clinical Trials
1,793,124 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have an upper or lower limb amputation at least 12 weeks prior to enrollment distal to the shoulder or hip, respectively, and including at least one metacarpal or metatarsal bone, respectively.
You have experienced pain in your amputated limb for at least 2 months.
You are willing to avoid both changes to your analgesic regimen as well as elective surgical procedures for 70 days after initiation of treatment with PEMF therapy.

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.