STAMP Study: Stimulation for Amputation Pain Management
University of Delaware
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. 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.
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, s…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Open wound in any area that is covered…
Interventions
- DeviceStrong But Comfortable 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.
- DeviceJust Perceptible TENS
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.
Location
- International Institute of Orthotics and ProstheticsTampa, Florida