Pulsed Electromagnetic Fields for Post-Amputation Pain

NCT05392803 | Completed Results FDA Device

• 1 other identifier: PEMF Amputee Pilot
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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 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

Outcome Measures

Primary Outcomes (4)

• Change in Average RESIDUAL Limb Pain Scores Between Baseline and Day 28 of the Initial Treatment as Measured With the Numeric Rating Scale

  The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale. The outcome will be the difference between the baseline and Day 28 timepoints.

  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

  The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale. The outcome will be the difference between the baseline and Day 28 timepoints.

  Baseline and Day 28

• Patient Global Impression of Change for RESIDUAL Limb Pain Between Baseline and Day 28 of the Initial Treatment

  A 7-point Likert scale with 1 equivalent to "much worse", 4 equivalent to "no change", and 7 equivalent to "much improved". Patients compare their current pain level with baseline using this scale.

  Day 28

• Patient Global Impression of Change for PHANTOM Limb Pain Between Baseline and Day 28 of the Initial Treatment

  A 7-point Likert scale with 1 equivalent to "much worse", 4 equivalent to "no change", and 7 equivalent to "much improved". Patients compare their current pain level with baseline using this scale.

  Day 28

Secondary Outcomes (15)

• Patient Global Impression of Change for RESIDUAL Limb Pain

  Days 2, 4, 7, 21, 28, and 35

• Patient Global Impression of Change for PHANTOM Limb Pain

  Days 2, 4, 7, 21, 28, and 35

• Change in AVERAGE RESIDUAL Pain From Baseline Measured With the Numeric Rating Scale

  Days 2, 4, 7, 21, 28, and 35

• Change in WORST RESIDUAL Pain From Baseline Measured With the Numeric Rating Scale

  Days 2, 4, 7, 21, 28, and 35

• Change in LEAST RESIDUAL Pain From Baseline Measured With the Numeric Rating Scale

  Days 28 and 35

Study Arms (2)

Active then Sham Treatment

EXPERIMENTAL

Application of 30 days of nonthermal, pulsed shortwave (radiofrequency) therapy, 7 day "washout", 30 days of sham.

Device: Active then Sham Treatment

Sham then Active Treatment

EXPERIMENTAL

Application of 30 days of a nonfunctional sham device, 7 day "washout", then 30 days of nonthermal, pulsed shortwave (radiofrequency) therapy

Device: Sham then Active Treatment

Interventions

Active then Sham Treatment DEVICE

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

Also known as: nonthermal, pulsed shortwave (radiofrequency) therapy then sham, pulsed electromagnetic fields therapy then sham

Active then Sham Treatment

Sham then Active Treatment DEVICE

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

Also known as: Sham then nonthermal, pulsed shortwave (radiofrequency) therapy, Sham then pulsed electromagnetic fields therapy

Sham then Active Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

Univerity of California San Diego

San Diego, California, 92103, United States

Location

MeSH Terms

Conditions

Phantom Limb

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain

Results Point of Contact

• Title: Brian Ilfeld, MD, MS
• Organization: University of California San Diego

baabdullah@health.ucsd.edu

(858) 220-5714

Study Officials

• Brian Ilfeld, MD, MS

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The Investigational Drug Service will create the randomization tables and provide the investigators with the appropriate device (active or sham), leaving all participants, investigators, and the statistician masked to treatment group assignment.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology, In Residence

Model Details: Participants will be randomized to either active or sham treatment for 30 days; and will then crossover and receive the alternative treatment for 30 additional days. The primary analysis will compare the initially-randomized active and sham treatment groups--thus, a parallel group (inter-participant) comparison; but secondary analyses will compare intra-participant changes as well.

Study Record Dates

• First Submitted: May 19, 2022
• First Posted: May 26, 2022
• Study Start: August 5, 2022
• Primary Completion: August 10, 2023
• Study Completion: August 17, 2023
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)