Amputation Pain
Conditions
Keywords
pain, amputation, electrical stimulation
Brief 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.
Detailed 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, 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.
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.
Sponsors
University of Delaware
International Institute of Orthotics and Prosthetics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Random assignment, stratified by sex given sex-specific differences in pain following lower-limb amputation, will be used. Participants will be randomly allocated to each of the treatment arms, i.e., 'strong but comfortable' transcutaneous electrical stimulation or 'just perceptible' transcutaneous electrical stimulation at a 2:1 ratio.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 by the suit * An acute infection or injury (e.g., fracture) * Deep vein thrombosis * Bowel and/or bladder incontinence
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity | Immediately following treatment sessions 2-3 weeks post-baseline | Using Numeric Pain Rating Scale, where 0=no pain and 10=worst imaginable pain |
| Pain Interference | Immediately following treatment sessions 2-3 weeks post-baseline | 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) |
| Global Rating of Change | Immediately following treatment sessions 2-3 weeks post-baseline | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-Reported Physical Function | Immediately following treatment sessions 2-3 weeks post-baseline | 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 |
| 6-Minute Walk Test | Immediately following treatment sessions 2-3 weeks post-baseline | Participants cover as much ground as possible in 6-minutes, with greater distances in meters indicating better walking endurance |
| Self-Selected Gait Speed | Immediately following treatment sessions 2-3 weeks post-baseline | 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 |
| Fast Gait Speed | Immediately following treatment sessions 2-3 weeks post-baseline | 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 |
| Chair Rise | Immediately following treatment sessions 2-3 weeks post-baseline | 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 |
| Functional Reach | Immediately following treatment sessions 2-3 weeks post-baseline | 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. |
| Pain Extent | Immediately following treatment sessions 2-3 weeks post-baseline | 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 |
| Sleep Quality | Immediately following treatment sessions 2-3 weeks post-baseline | 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 |
Countries
United States
Contacts
CONTACTJ. Megan Sions, PT, DPT, PhD
Outcome results
None listed