Amputation PainSTAMPNCT07759219
Stimulation for Amputation Pain Management
A study testing Strong But Comfortable TENS and Just Perceptible TENS in people with Amputation Pain, run by University of Delaware at 1 site in United States.
Trial summary
The goal of this clinical trial is to see if electrical stimulation applied through the application of a wearable suit improves pain and function among adults with lower-limb amputation who report pain in two or more body regions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amputation Pain
- What is being tested?
- Strong But Comfortable TENS and Just Perceptible TENS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English-speaking and reading to enable informed consent and participation
- Report of pain in 2/more body regions for at least 3 months duration per site • Report of at least moderate intensity pain over the past 7 days
Who cannot join
- An amputation of the contralateral lower-limb > toe-level
- Do not currently use a prosthesis to ambulate
- Diagnosed cognitive impairment (e.g., dementia, traumatic brain injury)
- Severe vision (e.g., blind) or hearing loss (e.g., deaf)
- Are currently pregnant
- Active cancer/malignancy
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- Open wound in any area that is covered by the suit
- An acute infection or injury (e.g., fracture)
- Deep vein thrombosis
- Bowel and/or bladder incontinence
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
International Institute of Orthotics and Prosthetics
Tampa, Florida, 33634
Arlene Gillis, 813-517-1740
Michael Hoggatt, PT, DPT, MSPO
About this study
Official title: STAMP Study: Stimulation for Amputation Pain Management
The goal of this clinical trial is to see if electrical stimulation applied through the application of a wearable suit improves pain and function among adults with lower-limb amputation who report pain in two or more body regions. The main questions this study seeks to answer are:
- Does the suit provide a viable treatment option for pain management?
- Does the intensity of electrical stimulation matter? Researchers will compare two different intensities of electrical stimulation applied through application of a wearable suit to see the immediate, sustained and cumulative effects on pain and function among adults with lower-limb amputation.
Read more
Participants will:
- Fill out questionnaires online.
- Undergo two onsite clinical examinations.
- Complete 10 treatment sessions over 2-3 weeks.
Read the detailed description
Persistent post-amputation pain affects >50% of adults with lower-limb amputation, has significant functional consequences including negative effects on mobility, and lacks effective treatment options. Persistent phantom limb pain is defined as chronic, post-amputation sensations that are described as episodic, painful stabbing, electric shock, or cramping in the absent limb region, and/or feeling as if the phantom limb is 'frozen in an awkward position'. Pain in the remaining portion of the amputation limb is also possible (termed residual limb pain), as well as pain in other body regions, such as the low back and hips. In fact, prior research has found that 60% of adults with lower-limb amputation have pain in multiple regions, which is termed 'multisite' pain. Among adults with lower-limb amputation, the Delaware Limb Loss Studies research laboratory found multisite pain is associated with greater activity restrictions, falls, and more recently, found that multisite pain is associated with worse mobility, specifically reduced walking speed and endurance. Electrical stimulation is a treatment technique commonly used in physical therapy for pain management. Electrical current applied to the skin is used to stimulate nerves and muscles. Electrical stimulation has been shown to be an effective treatment for pain in adults with bone and joint conditions, like knee arthritis and hip fractures. In this treatment trial, the immediate (short-term) effects of multiple sessions of multiple body region electrical stimulation on pain and function among adults with lower-limb amputation will be evaluated. The primary goal of this project is to determine if multisite electrical stimulation may improve pain and/or function among adults with lower-limb amputation who report moderate-intensity, multisite pain.
- Conditions
- Amputation Pain
- Being tested
- Strong But Comfortable TENS, Just Perceptible TENS
- Keywords
- pain, amputation, electrical stimulation
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strong But Comfortable TENSDevice
All pads of the electrical stimulation suit will be turned on to an intensity that is perceived as 'strong but comfortable', but without a muscle contraction. Transcutaneous electrical stimulation (TENS) intensities will be recorded each visit and determined at each treatment session, without referencing prior stimulation intensities. TENS will be applied for 40 minutes.
Just Perceptible TENSDevice
All pads of the electrical stimulation suit will be turned on to a 'just perceptible' intensity. Transcutaneous electrical stimulation (TENS) intensities will be recorded each visit and determined at each treatment session, without referencing prior stimulation intensities. TENS will be applied for 40 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Strong but Comfortable TENS | Experimental | Participants in this group will received 'strong but comfortable' intensity transcutaneous electrical stimulation (TENS) for up to 10 treatment sessions over 2 weeks. Receives: Device: Strong But Comfortable TENS |
| Just Perceptible TENS | Experimental | Participants in this group will receive 'just perceptible' intensity transcutaneous electrical stimulation (TENS) for up to 10 treatment sessions over 2 weeks. Receives: Device: Just Perceptible TENS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
Using Numeric Pain Rating Scale, where 0=no pain and 10=worst imaginable pain
Measured: Immediately following treatment sessions 2-3 weeks post-baseline
Pain Interference
Patient Reported Outcome Measurement Information System (PROMIS) 29-item: Pain Interference Subscale: reported as a T-score where 50 represents the mean of the United States (US) population and every 10 points above 50 represents one standard deviation above the US mean (more pain interference) and every 10 points below 50 represents one standard deviation below the US mean (less pain interference)
Measured: Immediately following treatment sessions 2-3 weeks post-baseline
Global Rating of Change
Participants will rate their overall improvement on a 15-point scale that ranges from -7 (a very great deal worse) to +7 (a very great deal better).
Measured: Immediately following treatment sessions 2-3 weeks post-baseline
Secondary outcomes (8)
Self-Reported Physical Function
Prosthetic Limb Users Survey of Mobility: a 12-item measure evaluating mobility in the home and community, where T-scores of 50 represent that mean mobility of a reference sample of >1000 adults with lower-limb amputation using a prosthesis and higher scores indicate better prosthesis-enabled mobility
Measured: Immediately following treatment sessions 2-3 weeks post-baseline
6-Minute Walk Test
Participants cover as much ground as possible in 6-minutes, with greater distances in meters indicating better walking endurance
Measured: Immediately following treatment sessions 2-3 weeks post-baseline
Self-Selected Gait Speed
10-Meter Walk Test: Following a practice trial, two trials will be averaged to determine gait speed in meters/second over the central 6 meters of the course, where higher speeds indicate faster gait
Measured: Immediately following treatment sessions 2-3 weeks post-baseline
Fast Gait Speed
10-Meter Walk Test: Following a practice trial, two trials will be averaged to determine gait speed in meters/second over the central 6 meters of the course, where higher speeds indicate faster gait
Measured: Immediately following treatment sessions 2-3 weeks post-baseline
Chair Rise
30-Second Chair Rise Test: Asks participants to stand up and sit down as many times as possible in 30 seconds with their arms crossed over their chest from a standard height chair; a greater number of repetitions indicates better physical performance
Measured: Immediately following treatment sessions 2-3 weeks post-baseline
Functional Reach
Participants will complete 5 trials reaching with their upper limb on their prosthetic side, with the latter three trials recorded and averaged in centimeters. Greater distances reached indicate better balance.
Measured: Immediately following treatment sessions 2-3 weeks post-baseline
Pain Extent
Pain Body Diagrams: Participants will mark all locations of pain on figures sectioned into 59 distinct regions; a greater number of painful locations indicates greater extent of pain
Measured: Immediately following treatment sessions 2-3 weeks post-baseline
Sleep Quality
Pittsburgh Sleep Quality Index: a 19-item measure of sleep quality and sleep disturbances, providing a score from 0 to 21, where lower scores denote better sleep
Measured: Immediately following treatment sessions 2-3 weeks post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amputation PainStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Random assignment, stratified by sex given sex-specific differences in pain following lower-limb amputation, will be used. Participants will be randomly allocated to each of the treatment arms, i.e., 'strong but comfortable' transcutaneous electrical stimulation or 'just perceptible' transcutaneous electrical stimulation at a 2:1 ratio.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Delaware
- Sponsor type
- University, hospital or other
- Collaborators
- International Institute of Orthotics and Prosthetics
- Responsible party
- Principal investigator, Jaclyn Sions, University of Delaware
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07759219
- Sponsor's protocol ID
- 2317118
- Acronym
- STAMP
- Status last verified
- Aug 2026
- First submitted
- 3 Aug 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Deidentified patient participant data are available from the corresponding author upon reasonable request and with completion of a data use agreement to protect participant confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STAMP Study: Stimulation for Amputation Pain Management
- ClinicalTrials.gov ID
- NCT07759219
- Acronym / sponsor ID
- STAMP / 2317118
- Conditions
- Amputation Pain
- Keywords
- pain, amputation, electrical stimulation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of DelawareUniversity, hospital or other
- Collaborators
- International Institute of Orthotics and Prosthetics
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 12 Aug 2026 (actual)
- 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 clinical trial is to see if electrical stimulation applied through the application of a wearable suit improves pain and function among adults with lower-limb amputation who report pain in two or more body regions. The main questions this study seeks to answer are:
- Does the suit provide a viable treatment option for pain management?
- Does the intensity of electrical stimulation matter? Researchers will compare two different intensities of electrical stimulation applied through application of a wearable suit to see the immediate, sustained and cumulative effects on pain and function among adults with lower-limb amputation.
Participants will:
- Fill out questionnaires online.
- Undergo two onsite clinical examinations.
- Complete 10 treatment sessions over 2-3 weeks.
Detailed description
Persistent post-amputation pain affects >50% of adults with lower-limb amputation, has significant functional consequences including negative effects on mobility, and lacks effective treatment options. Persistent phantom limb pain is defined as chronic, post-amputation sensations that are described as episodic, painful stabbing, electric shock, or cramping in the absent limb region, and/or feeling as if the phantom limb is 'frozen in an awkward position'. Pain in the remaining portion of the amputation limb is also possible (termed residual limb pain), as well as pain in other body regions, such as the low back and hips. In fact, prior research has found that 60% of adults with lower-limb amputation have pain in multiple regions, which is termed 'multisite' pain. Among adults with lower-limb amputation, the Delaware Limb Loss Studies research laboratory found multisite pain is associated with greater activity restrictions, falls, and more recently, found that multisite pain is associated with worse mobility, specifically reduced walking speed and endurance. Electrical stimulation is a treatment technique commonly used in physical therapy for pain management. Electrical current applied to the skin is used to stimulate nerves and muscles. Electrical stimulation has been shown to be an effective treatment for pain in adults with bone and joint conditions, like knee arthritis and hip fractures. In this treatment trial, the immediate (short-term) effects of multiple sessions of multiple body region electrical stimulation on pain and function among adults with lower-limb amputation will be evaluated. The primary goal of this project is to determine if multisite electrical stimulation may improve pain and/or function among adults with lower-limb amputation who report moderate-intensity, multisite pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Random assignment, stratified by sex given sex-specific differences in pain following lower-limb amputation, will be used. Participants will be randomly allocated to each of the treatment arms, i.e., 'strong but comfortable' transcutaneous electrical stimulation or 'just perceptible' transcutaneous electrical stimulation at a 2:1 ratio.
| Arm | Type | Receives |
|---|---|---|
| Strong but Comfortable TENS | Experimental | Device: Strong But Comfortable TENSParticipants in this group will received 'strong but comfortable' intensity transcutaneous electrical stimulation (TENS) for up to 10 treatment sessions over 2 weeks. |
| Just Perceptible TENS | Experimental | Device: Just Perceptible TENSParticipants in this group will receive 'just perceptible' intensity transcutaneous electrical stimulation (TENS) for up to 10 treatment sessions over 2 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- English-speaking and reading to enable informed consent and participation
- Report of pain in 2/more body regions for at least 3 months duration per site • Report of at least moderate intensity pain over the past 7 days
Key exclusion criteria (10 listed)
- An amputation of the contralateral lower-limb > toe-level
- Do not currently use a prosthesis to ambulate
- Diagnosed cognitive impairment (e.g., dementia, traumatic brain injury)
- Severe vision (e.g., blind) or hearing loss (e.g., deaf)
- Are currently pregnant
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 |
|---|---|---|
| Strong But Comfortable TENSAll pads of the electrical stimulation suit will be turned on to an intensity that is perceived as 'strong but comfortable', but without a muscle contraction. Transcutaneous electrical stimulation (TENS) intensities will be recorded each visit and determined at each treatment session, without referencing prior stimulation intensities. TENS will be applied for 40 minutes. | Device | Strong but Comfortable TENS |
| Just Perceptible TENSAll pads of the electrical stimulation suit will be turned on to a 'just perceptible' intensity. Transcutaneous electrical stimulation (TENS) intensities will be recorded each visit and determined at each treatment session, without referencing prior stimulation intensities. TENS will be applied for 40 minutes. | Device | Just Perceptible TENS |
Primary outcome
Pain Intensity
Time frame: Immediately following treatment sessions 2-3 weeks post-baseline
Using Numeric Pain Rating Scale, where 0=no pain and 10=worst imaginable pain
Pain Interference
Time frame: Immediately following treatment sessions 2-3 weeks post-baseline
Patient Reported Outcome Measurement Information System (PROMIS) 29-item: Pain Interference Subscale: reported as a T-score where 50 represents the mean of the United States (US) population and every 10 points above 50 represents one standard deviation above the US mean (more pain interference) and every 10 points below 50 represents one standard deviation below the US mean (less pain interference)
Global Rating of Change
Time frame: Immediately following treatment sessions 2-3 weeks post-baseline
Participants will rate their overall improvement on a 15-point scale that ranges from -7 (a very great deal worse) to +7 (a very great deal better).
8 secondary outcomes
Self-Reported Physical Function
Time frame: Immediately following treatment sessions 2-3 weeks post-baseline
6-Minute Walk Test
Time frame: Immediately following treatment sessions 2-3 weeks post-baseline
Self-Selected Gait Speed
Time frame: Immediately following treatment sessions 2-3 weeks post-baseline
Fast Gait Speed
Time frame: Immediately following treatment sessions 2-3 weeks post-baseline
Chair Rise
Time frame: Immediately following treatment sessions 2-3 weeks post-baseline
Functional Reach
Time frame: Immediately following treatment sessions 2-3 weeks post-baseline
Pain Extent
Time frame: Immediately following treatment sessions 2-3 weeks post-baseline
Sleep Quality
Time frame: Immediately following treatment sessions 2-3 weeks post-baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: Yes. Deidentified patient participant data are available from the corresponding author upon reasonable request and with completion of a data use agreement to protect participant confidentiality.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strong But Comfortable TENS and Just Perceptible TENS in people with Amputation Pain, run by University of Delaware 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 2 inclusion and 10 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: opening soon, as of the sponsor's last update on 12 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact J. Megan Sions, PT, DPT, PhD (302-831-7231, megsions@udel.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (time frame: Immediately following treatment sessions 2-3 weeks post-baseline). The study lists 3 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 12 Aug 2026.