Status:
COMPLETED
Pulsed Electromagnetic Fields for Post-Amputation Pain
Lead Sponsor:
University of California, San Diego
Conditions:
Phantom Limb Pain
Residual Limb Pain
Eligibility:
All Genders
18+ years
Phase:
NA
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 a...
Detailed Description
The proposed study will be a randomized, participant- and observer-masked, sham-controlled, crossover, human participants pilot study with two primary aims: Specific Aim 1: To determine the feasibili...
Eligibility Criteria
Inclusion
- adult patients of at least 18 years of age \[19 years in Alabama and Nebraska\]
- with an upper or lower limb amputation at least 12 weeks prior to enrollment distal to the shoulder or hip (femoral head remaining), respectively, and including at least one metacarpal or metatarsal bone, respectively
- experience at least moderate residual and/or phantom limb pain-defined as a 3 or higher on the Numeric Rating Scale (NRS; 0-10, 0= no pain; 10=worst imaginable pain)-at least daily for the previous 2 months
- willing to avoid both changes to their analgesic regimen as well as elective surgical procedures for 70 days after initiation of treatment with PEMF therapy
Exclusion
- concurrent use of an implanted pulse generator (e.g., cardiac pacemaker)
- pregnancy
- incarceration
Key Trial Info
Start Date :
August 5 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 17 2023
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT05392803
Start Date
August 5 2022
End Date
August 17 2023
Last Update
September 19 2024
Active Locations (1)
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1
Univerity of California San Diego
San Diego, California, United States, 92103