Stimulation for Amputation Pain Management
Part of paid clinical trials in Tampa, Florida.
- Sponsor
- University of Delaware
- Study ID
- NCT07759219
- Status
- Not Yet Recruiting
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Conditions
- Amputation Pain
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Strong But Comfortable TENS — DEVICEAll 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 TENS — DEVICEAll 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 Details
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.
Key Dates
- First listed
- Aug 12, 2026
- Start date
- Sep 1, 2026
- Status verified
- Aug 2026
- Primary completion
- Aug 31, 2028
- Completion
- Aug 31, 2028
Study Design
- Enrollment
- 40 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: 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.
- Experimental: Just Perceptible TENSParticipants in this group will receive 'just perceptible' intensity transcutaneous electrical stimulation (TENS) for up to 10 treatment sessions over 2 weeks.
Primary Outcome Measure
Pain Intensity [ Time Frame: Immediately following treatment sessions 2-3 weeks post-baseline ]
Central Contacts
- J. Megan Sions, PT, DPT, PhD302-831-7231
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| International Institute of Orthotics and Prosthetics | Tampa | Florida | 33634 | Arlene Gillis 813-517-1740 Michael Hoggatt, PT, DPT, MSPO (SUB_INVESTIGATOR) |