- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03030079
Electrical Stimulus Therapy for Chronic Phantom Limb Pain
December 8, 2023 updated by: University of Colorado, Denver
Exploratory Study of Electrical Stimulus as a Treatment Option for Chronic Phantom Limb Pain
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Colorado
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Aurora, Colorado, United States, 80045
- Children's Hospital Colorado Research Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Device Feasibility
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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
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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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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.
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After each 20 minute treatment session up to 5 weeks
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Assess the effectiveness of reducing chronic phantom limb pain long term.
Time Frame: Weekly for 5 weeks
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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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Weekly for 5 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Richard Weir, PhD, University of Colorado, Denver
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2017
Primary Completion (Actual)
June 27, 2023
Study Completion (Actual)
June 28, 2023
Study Registration Dates
First Submitted
January 13, 2017
First Submitted That Met QC Criteria
January 19, 2017
First Posted (Estimated)
January 24, 2017
Study Record Updates
Last Update Posted (Estimated)
December 11, 2023
Last Update Submitted That Met QC Criteria
December 8, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16-1063
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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