Phantom Limb PainNCT03030079
Electrical Stimulus Therapy for Chronic Phantom Limb Pain
A study testing Experimental Electrical Stimulation Regimen in people with Phantom Limb Pain, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Phantom Limb Pain
- What is being tested?
- Experimental Electrical Stimulation Regimen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2017to 28 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Colorado Research Institute
Aurora, Colorado, 80045
About this study
Official title: 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.
Read the 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.
- Conditions
- Phantom Limb Pain
- Being tested
- Experimental Electrical Stimulation Regimen
- Medical subject headings
- Phantom Limb
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental Electrical Stimulation RegimenDevice
Also called Device: Omnistim FX2 Pro
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Electrical stimulation Regimen | Experimental | Explore the efficacy of an electrical stimulus regimen on the treatment of chronic phantom limb pain using a standard-of-care electrical stimulation system Receives: Device: Experimental Electrical Stimulation Regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of electrical stimulus medium frequency alternating current for short term decreased Phantom Limb Pan
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.
Measured: After each 20 minute treatment session up to 5 weeks
Assess the effectiveness of reducing chronic phantom limb pain long term.
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.
Measured: Weekly for 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2017 (estimated)
- Study start1 Jan 2017
- Primary completion27 Jun 2023
- Study completion28 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Phantom Limb PainStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Hanger Clinic: Prosthetics & Orthotics
- Responsible party
- Sponsor
- Investigators
- Richard Weir, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03030079
- Sponsor's protocol ID
- 16-1063
- Status last verified
- Dec 2023
- First submitted
- 13 Jan 2017
- Last updated
- 11 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study of Electrical Stimulus as a Treatment Option for Chronic Phantom Limb Pain
- ClinicalTrials.gov ID
- NCT03030079
- Acronym / sponsor ID
- 16-1063
- Conditions
- Phantom Limb Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Hanger Clinic: Prosthetics & Orthotics
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 27 Jun 2023 (actual)
- Study completion
- 28 Jun 2023 (actual)
- First posted
- 24 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Electrical stimulation Regimen | Experimental | Device: Experimental Electrical Stimulation RegimenExplore the efficacy of an electrical stimulus regimen on the treatment of chronic phantom limb pain using a standard-of-care electrical stimulation system |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental Electrical Stimulation RegimenAlso: Device: Omnistim FX2 ProThe 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. | Device | Experimental Electrical stimulation Regimen |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Weir, PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Electrical Stimulation Regimen in people with Phantom Limb Pain, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2023.