Stimulation for Amputation Pain Management
ConditionAmputation Pain
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Delaware
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Strong But Comfortable TENS
- Just Perceptible TENS
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Delaware
Lead sponsor
International Institute of Orthotics and Prosthetics
Collaborator
Source ClinicalTrials.gov