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Electromagnetic Field Therapy
Active then Sham Treatment for Phantom Limb Pain
N/A
Waitlist Available
Led By Brian Ilfeld, MD, MS
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 2, 4, 7, 21, 28, and 35 for both initial and crossover treatments
Awards & highlights
Study Summary
This trial is testing if a non-invasive, painless electromagnetic therapy can help relieve chronic pain for people who have had an amputation.
Eligible Conditions
- Phantom Limb Pain
- Residual Limb Pain
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ days 2, 4, 7, 21, 28, and 35 for both initial and crossover treatments
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 2, 4, 7, 21, 28, and 35 for both initial and crossover treatments
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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
Patient Global Impression of Change for PHANTOM limb pain between baseline and Day 28 of the initial treatment
+1 moreSecondary outcome measures
As-needed (non-scheduled) analgesic use
Awakenings due to pain the previous evening
Brief pain inventory, short form (interference sub scale)
+12 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Sham then Active TreatmentExperimental Treatment1 Intervention
Application of 30 days of a nonfunctional sham device, 7 day "washout", then 30 days of nonthermal, pulsed shortwave (radiofrequency) therapy
Group II: Active then Sham TreatmentExperimental Treatment1 Intervention
Application of 30 days of nonthermal, pulsed shortwave (radiofrequency) therapy, 7 day "washout", 30 days of sham.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Active then Sham Treatment
2022
N/A
~30
Sham then Active Treatment
2022
N/A
~30
Find a Location
Who is running the clinical trial?
University of California, San DiegoLead Sponsor
1,130 Previous Clinical Trials
1,552,833 Total Patients Enrolled
Brian Ilfeld, MD, MSPrincipal InvestigatorUniversity of California, San Diego
4 Previous Clinical Trials
263 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been feeling moderate pain or discomfort in a missing limb or body part, with a score of 3 or higher on a scale of 0 to 10, for at least the past two months.You cannot change your pain medication or have any elective surgeries for 70 days after starting PEMF therapy, and you agree to this.You are pregnant.You had an amputation in your arm or leg below the shoulder or hip, which occurred at least 12 weeks ago and involved at least one bone in your hand or foot.
Research Study Groups:
This trial has the following groups:- Group 1: Active then Sham Treatment
- Group 2: Sham then Active Treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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