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Pulsed Electromagnetic Fields for Post-Amputation Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05392803
Recruitment Status : Recruiting
First Posted : May 26, 2022
Last Update Posted : May 31, 2022
Sponsor:
Information provided by (Responsible Party):
Brian M. Ilfeld, MD, MS, University of California, San Diego

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.

Condition or disease Intervention/treatment Phase
Phantom Limb Pain Residual Limb Pain Device: Active then Sham Treatment Device: Sham then Active Treatment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: 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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Pulsed Electromagnetic Fields for Post-Amputation Pain: A Randomized, Triple-Masked, Sham-Controlled, Crossover Pilot Study
Actual Study Start Date : May 19, 2022
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : March 2023

Arm Intervention/treatment
Experimental: Active then Sham Treatment
Application of 30 days of nonthermal, pulsed shortwave (radiofrequency) therapy, 7 day "washout", 30 days of sham.
Device: Active then Sham Treatment
Application of 30 days of nonthermal, pulsed shortwave (radiofrequency) therapy; then sham treatment after a 7-day "washout" period
Other Names:
  • nonthermal, pulsed shortwave (radiofrequency) therapy then sham
  • pulsed electromagnetic fields therapy then sham

Experimental: Sham then Active Treatment
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
Application of 30 days of sham treatment; then 30 days of nonthermal, pulsed shortwave (radiofrequency) therapy after a 7-day "washout" period
Other Names:
  • Sham then nonthermal, pulsed shortwave (radiofrequency) therapy
  • Sham then pulsed electromagnetic fields therapy




Primary Outcome Measures :
  1. Change in average RESIDUAL limb pain scores between baseline and Day 28 of the initial treatment as measured with the Numeric Rating Scale [ Time Frame: Baseline and Day 28 ]
    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.

  2. Change in average PHANTOM limb pain scores between baseline and Day 28 of the initial treatment as measured with the Numeric Rating Scale [ Time Frame: Baseline and Day 28 ]
    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.

  3. Patient Global Impression of Change for RESIDUAL limb pain between baseline and Day 28 of the initial treatment [ Time Frame: Day 28 ]
    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.

  4. Patient Global Impression of Change for PHANTOM limb pain between baseline and Day 28 of the initial treatment [ Time Frame: Day 28 ]
    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.


Secondary Outcome Measures :
  1. Patient Global Impression of Change for RESIDUAL limb pain [ Time Frame: Days 2, 4, 7, 21, 28, and 35 for both initial and crossover treatments ]
    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.

  2. Patient Global Impression of Change for PHANTOM limb pain [ Time Frame: Days 2, 4, 7, 21, 28, and 35 for both initial and crossover treatments ]
    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.

  3. Change in AVERAGE RESIDUAL pain from baseline measured with the Numeric Rating Scale [ Time Frame: Days 2, 4, 7, 21, 28, and 35 for both initial and crossover treatments ]
    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 the difference between the baseline and current pain level measured with the Numeric Rating Scale

  4. Change in WORST RESIDUAL pain from baseline measured with the Numeric Rating Scale [ Time Frame: Days 2, 4, 7, 21, 28, and 35 for both initial and crossover treatments ]
    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 the difference between the baseline and current pain level measured with the Numeric Rating Scale

  5. Change in LEAST RESIDUAL pain from baseline measured with the Numeric Rating Scale [ Time Frame: Days 28 and 35 for both initial and crossover treatments ]
    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 the difference between the baseline and current pain level measured with the Numeric Rating Scale

  6. Change in CURRENT RESIDUAL pain from baseline measured with the Numeric Rating Scale [ Time Frame: Days 28 and 35 for both initial and crossover treatments ]
    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 the difference between the baseline and current pain level measured with the Numeric Rating Scale

  7. Change in AVERAGE PHANTOM pain from baseline measured with the Numeric Rating Scale [ Time Frame: Days 2, 4, 7, 21, 28, and 35 for both initial and crossover treatments ]
    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 the difference between the baseline and current pain level measured with the Numeric Rating Scale

  8. Change in WORST PHANTOM pain from baseline measured with the Numeric Rating Scale [ Time Frame: Days 2, 4, 7, 21, 28, and 35 for both initial and crossover treatments ]
    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 the difference between the baseline and current pain level measured with the Numeric Rating Scale

  9. Change in LEAST PHANTOM pain from baseline measured with the Numeric Rating Scale [ Time Frame: Days 28 and 35 for both initial and crossover treatments ]
    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 the difference between the baseline and current pain level measured with the Numeric Rating Scale

  10. Change in CURRENT PHANTOM pain from baseline measured with the Numeric Rating Scale [ Time Frame: Days 28 and 35 for both initial and crossover treatments ]
    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 the difference between the baseline and current pain level measured with the Numeric Rating Scale

  11. As-needed (non-scheduled) analgesic use [ Time Frame: Inquired on Day 2, 4, 7, 21, 28 and 35 for both initial and crossover treatments ]
    Patient's perception of requirements over the previous 24 hours of as-needed (non-scheduled) analgesic use

  12. Brief pain inventory, short form (interference sub scale) [ Time Frame: Inquired on Days 28 and 35 for both initial and crossover treatments ]
    The Brief pain Inventory (short form) is an instrument specifically designed to assess pain and its impact on physical and emotional functioning. The brief Inventory is comprised of three domains: (1) pain, with four questions involving "worst", "average" and "current" pain levels using a 0-10 numeric rating scale;(2) percentage of relief provided by pain treatments with one question [reported score is the percentage divided by 10 and then subtracted from 10: 0=complete relief,10=no relief] and, (3) interference with 7 questions involving physical and emotional functioning using a 0-10 Likert scale [0=no interference;10=complete interference]: general activity, mood, walking ability, normal work, relations with other people, sleep and enjoyment of life. This outcome will include the interference subscale.

  13. Awakenings due to pain the previous evening [ Time Frame: Inquired on Days 2, 4, 7, 21, 28, and 35 for both initial and crossover treatments ]
    The number of awakenings due to pain that occurred the previous evening

  14. Does patient want to continue using device? [ Time Frame: Inquired on Day 35 for both initial and crossover treatments ]
    Does the patient want to continue using device answered as "yes", "no" or "unsure"

  15. Device location changes [ Time Frame: Inquired on Days 2, 4, 7, 21, 28 and 35 for both initial and crossover treatments ]
    If a patient moves the anatomic location of one or both of the intervention devices (and where the device is moved to) since the last contact



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05392803


Contacts
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Contact: Baharin Abdullah, MD (858) 220-5714 baabdullah@health.ucsd.edu
Contact: Brian Ilfeld, MD, MS (858) 242-6017 bilfeld@health.ucsd.edu

Locations
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United States, California
Univerity of California San Diego Recruiting
San Diego, California, United States, 92103
Contact: Baharin Abdullah, MD    858-220-5714    baabdullah@health.ucsd.edu   
Contact: Brian Ilfeld, MD, MS    (858) 242-6017    bilfeld@health.ucsd.edu   
Sponsors and Collaborators
University of California, San Diego
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Responsible Party: Brian M. Ilfeld, MD, MS, Professor of Anesthesiology, In Residence, University of California, San Diego
ClinicalTrials.gov Identifier: NCT05392803    
Other Study ID Numbers: PEMF Amputee Pilot
First Posted: May 26, 2022    Key Record Dates
Last Update Posted: May 31, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Phantom Limb
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain