Electrical Stimulus Therapy for Chronic Phantom Limb Pain
|ClinicalTrials.gov Identifier: NCT03030079|
Recruitment Status : Enrolling by invitation
First Posted : January 24, 2017
Last Update Posted : June 4, 2020
|Condition or disease||Intervention/treatment||Phase|
|Phantom Limb Pain||Device: Experimental Electrical Stimulation Regimen||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|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|
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
- 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.
- 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.
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
|United States, Colorado|
|Children's Hospital Colorado Research Institute|
|Aurora, Colorado, United States, 80045|
|Principal Investigator:||Richard Weir, PhD||University of Colorado, Denver|