N/A N=14 Randomized Quadruple-blind Treatment

Pulsed Electromagnetic Fields for Post-Amputation Pain

Phantom Limb Pain · Residual Limb Pain

Bottom Line

View on ClinicalTrials.gov: NCT05392803 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2024

Primary outcome: Primary: Change in Average RESIDUAL Limb Pain Scores Between Baseline and Day 28 of the Initial Treatment as Measured With the Numeric Rating Scale — 2.5; 0 score on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Active then Sham Treatment (Device); Sham then Active Treatment (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of California, San Diego
Primary completion: Aug 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Average RESIDUAL Limb Pain Scores Between Baseline and Day 28 of the Initial Treatment as Measured With the Numeric Rating Scale	2.5; 0	—
PRIMARY Change in Average PHANTOM Limb Pain Scores Between Baseline and Day 28 of the Initial Treatment as Measured With the Numeric Rating Scale	2.3; 0	—
PRIMARY Patient Global Impression of Change for RESIDUAL Limb Pain Between Baseline and Day 28 of the Initial Treatment	7; 4	—
PRIMARY Patient Global Impression of Change for PHANTOM Limb Pain Between Baseline and Day 28 of the Initial Treatment	6.5; 4	—
SECONDARY Patient Global Impression of Change for RESIDUAL Limb Pain	4; 4; 5; 4; 5; 4	—
SECONDARY Patient Global Impression of Change for PHANTOM Limb Pain	5; 4; 5; 4; 6.5; 4	—
SECONDARY Change in AVERAGE RESIDUAL Pain From Baseline Measured With the Numeric Rating Scale	2.5; 4; 3; 4; 2; 4	—
SECONDARY Change in WORST RESIDUAL Pain From Baseline Measured With the Numeric Rating Scale	3.5; 5; 3; 5; 3; 5	—
SECONDARY Change in LEAST RESIDUAL Pain From Baseline Measured With the Numeric Rating Scale	0; 3.5; 0; 0	—
SECONDARY Change in CURRENT RESIDUAL Pain From Baseline Measured With the Numeric Rating Scale	0; 4; 1; 1	—
SECONDARY Change in AVERAGE PHANTOM Pain From Baseline Measured With the Numeric Rating Scale	4.5; 3; 4; 3.5; 2; 4	—
SECONDARY Change in WORST PHANTOM Pain From Baseline Measured With the Numeric Rating Scale	6; 5; 4.7; 6.5; 3.5; 5	—
SECONDARY Change in LEAST PHANTOM Pain From Baseline Measured With the Numeric Rating Scale	0; 0; 0; 1	—
SECONDARY Change in CURRENT PHANTOM Pain From Baseline Measured With the Numeric Rating Scale	3; 3; 3.5; 4	—
SECONDARY As-needed (Non-scheduled) Analgesic Use	—	—
SECONDARY Brief Pain Inventory, Short Form (Interference Sub Scale)	19.7; 20.9; 34; 28	—
SECONDARY Awakenings Due to Pain the Previous Evening	0; .1; .6; 1.9; .4; .1	—
SECONDARY Does Patient Want to Continue Using Device (Participants Answering "Yes")?	7; 2	—
SECONDARY Device Location Changes	0; 0; 1; 0; 1; 0	—

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.

Eligibility Criteria

Inclusion Criteria

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 Criteria

concurrent use of an implanted pulse generator (e.g., cardiac pacemaker)
pregnancy
incarceration

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05392803). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.