An interventional study of Strong But Comfortable TENS and Just Perceptible TENS in Amputation Pain, sponsored by University of Delaware. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by University of Delaware · Not applicable, Interventional, and Treatment
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:
Participants will:
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.
10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.
This study's planned enrollment of 40 is below the median of 66 across 8,493 interventional studies indexed under Pain.
Browse Pain studies →University of Delaware is the lead sponsor of 128 studies on the registry; 22 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this group will received 'strong but comfortable' intensity transcutaneous electrical stimulation (TENS) for up to 10 treatment sessions over 2 weeks.
Device: Strong But Comfortable TENS
Participants in this group will receive 'just perceptible' intensity transcutaneous electrical stimulation (TENS) for up to 10 treatment sessions over 2 weeks.
Device: Just Perceptible TENS
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.
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.
Pain Intensity
Using Numeric Pain Rating Scale, where 0=no pain and 10=worst imaginable pain
Time frame: 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)
Time frame: 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).
Time frame: Immediately following treatment sessions 2-3 weeks post-baseline
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: Immediately following treatment sessions 2-3 weeks post-baseline
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Individual patient participant data that underlie results will be available beginning 3 months following publication of the primary results and ending 5 years following publication of the primary results to researchers who provide a methodologically sound proposal and complete a data sharing agreement.
Access criteria: Proposals should be directed to J. Megan Sions, PT, DPT, PhD, the study's principal investigator, in writing at megsions@udel.edu. To gain access to individual patient participant data, requestors will need to sign a data access agreement with the principal investigator's home institution, i.e., the University of Delaware.
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Aug 2028, 23 months later.
Of 3,731 non-industry interventional studies with no phase under Pain, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 23. This study's planned 23 months is above that.
Counting every sponsor, half of 3,830 studies reached it within 10 months; a quarter within 4 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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