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Electrical Stimulus Therapy for Chronic Phantom Limb Pain

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ClinicalTrials.gov Identifier: NCT03030079
Recruitment Status : Enrolling by invitation
First Posted : January 24, 2017
Last Update Posted : June 4, 2020
Sponsor:
Collaborator:
Hanger Clinic: Prosthetics & Orthotics
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:
The goal of this pilot study is to assess the effectiveness of an electrical stimulation therapy option for the treatment of chronic phantom limb pain in upper or lower limb amputees. This therapy has been previously used for sports and joint injuries and is marketed for relaxation of muscle spasms, re-education of muscle action, prevention of disuse atrophy, increased local blood circulation, and maintaining or increasing range of motion. The investigators would like to explore the idea that physically exercising the muscles of the residual limb and increasing blood flow to the site of amputation through the promotion of motor contraction using electrical stimulation decreases chronic phantom limb pain.

Condition or disease Intervention/treatment Phase
Phantom Limb Pain Device: Experimental Electrical Stimulation Regimen Not Applicable

Detailed Description:
There are a large number of people living with an amputation due mainly to cardiovascular disease, diabetes, and trauma; and of these there is evidence to show that up to 80% of amputees experience phantom limb pain (PLP). PLP is classified as cramping, burning, shooting, or stabbing pain in the missing limb following an amputation. Current treatments include pharmacological drugs, anesthesia, additional surgery, mirror therapy, transcutaneous electrical nerve stimulation (TENS) and others. TENS, as usually implemented, has been used to effectively reduce pain in multiple spots of the body, but has shown little effect in reducing phantom limb pain especially long term even with varying the frequency and intensity of the electrical stimulation. These current treatments can be invasive, costly, and have shown only to offer immediate relief. Using an electrical stimulator at a higher intensity has proven to to reduce pain and increase healing in numerous sports and joint related injuries. Anecdotally, the investigators have learned that a similar treatment protocol when applied to persons with phantom limb pain can mitigate their pain. The goal of this pilot study is to assess the effectiveness of higher intensity electrical stimulation in the management of PLP and also to acquire data to inform the investigators to the most appropriate study design and power for a future more formal clinical trial. To accomplish this the investigators will utilize the ACP Omnistim FX2 Pro electrical stimulator, that has been provided to us by Accelerated Care Plus (ACP) Corporation, to physically exercise the muscles of the residual limb and hence increase the local blood flow and explore it's potential for treatment of PLP both short and long term. The self-identified subject will be hooked up to the ACP electrical stimulator using surface electrodes that will pass a current through the skin first at a low intensity for 5 minutes to allow the subject to adjust to the tingling sensation. The current will then be gradually increased to a level sufficient to elicit a non-painful motor contraction for 15 minutes. Using a numerical pain scale and short answer questions about the characteristics of the pain the investigators will track both short term and long term changes in pain.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Exploratory Study of Electrical Stimulus as a Treatment Option for Chronic Phantom Limb Pain
Study Start Date : January 2017
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2026

Arm Intervention/treatment
Experimental: Experimental Electrical stimulation Regimen
Explore the efficacy of an electrical stimulus regimen on the treatment of chronic phantom limb pain using a standard-of-care electrical stimulation system
Device: Experimental Electrical Stimulation Regimen
The electrodes will pass an electrical current through the skin and into the muscle first at a low intensity for 5 minutes to allow the subject to adjust to the sensation. The current will then be gradually increased to a level sufficient to elicit a non-painful motor contraction. The subject will sit in a relaxed position as the electrical stimulator contracts the muscles for a duration of 15 minutes.
Other Name: Device: Omnistim FX2 Pro




Primary Outcome Measures :
  1. Use of electrical stimulus medium frequency alternating current for short term decreased Phantom Limb Pan [ Time Frame: After each 20 minute treatment session up to 5 weeks ]
    Pain level data will be taken before and after each session to analyze any short term decreases in pain using a self-reported numeric 10-point pain scale. T- tests will be used for within subject testing looking at pre and post treatment measures to quantify a decrease in pain.

  2. Assess the effectiveness of reducing chronic phantom limb pain long term. [ Time Frame: Weekly for 5 weeks ]
    An overall sustained decrease in phantom limb pain will be assessed weekly using a self-reported numeric 10-point pain scale. ANOVAs will be used to look at trends in post treatment measures over time.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Self-identified adult volunteers with a limb deficiency with a well-healed site of amputation
  • Subjects experiencing at least a 4 out of 10 of chronic phantom limb pain based on a numeric 10-point pain scale.
  • Any ethnicity and gender
  • Age (18-85 years)
  • Able to understand and follow directions in English, assessed by their ability to respond during the recruitment and consent processes.

Exclusion Criteria:

  • Subjects that are not able to understand the procedures and who are unable to come to the facility.
  • Any individual whose amputation site is not completely healed
  • Anyone with cardiac demand pacemakers and/or implanted defibrillator.

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): NCT03030079


Locations
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United States, Colorado
Children's Hospital Colorado Research Institute
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Hanger Clinic: Prosthetics & Orthotics
Investigators
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Principal Investigator: Richard Weir, PhD University of Colorado, Denver
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03030079    
Other Study ID Numbers: 16-1063
First Posted: January 24, 2017    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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.: No
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