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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Strong but Comfortable TENSExperimental treatment 1 intervention
Group B: Just Perceptible TENSExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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-baseline2
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-baseline3
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-baselineSecondary outcomes
1
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-baseline2
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-baseline3
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-baseline4
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-baselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Delaware
Lead sponsor
International Institute of Orthotics and Prosthetics
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: